WO2023200837A1

WO2023200837A1 - Compositions and methods of treating inflammation using prevotella histicola

Info

Publication number: WO2023200837A1
Application number: PCT/US2023/018282
Authority: WO
Inventors: Duncan MCHALE
Original assignee: Evelo Biosciences, Inc.
Priority date: 2022-04-13
Filing date: 2023-04-12
Publication date: 2023-10-19

Abstract

Provided herein are solid dosage forms containing Prevotella bacteria useful as therapeutics, e.g., for the treatment of inflammatory disease.

Description

COMPOSITIONS AND METHODS OF TREATING INFLAMMATION USING

PREVOTELLA HISTICOLA

CROSS-REFERENCE TO RELATED APPLICATIONS

[1] This application claims the benefit of U.S. Provisional Application No. 63/330,498, filed on April 13, 2022, the content of which is hereby incorporated by reference in its entirety.

SUMMARY

[2] In some aspects, provided herein are bacterial compositions (e.g., pharmaceutical compositions) comprising Prevotella histicola useful for the treatment and/or prevention of an inflammatory disease. In some embodiments, the inflammatory disease is a Thl, Th2, or Thl7 inflammatory disease. In some aspects, provided herein are bacterial compositions (e.g, pharmaceutical compositions) comprising Prevotella histicola useful for the treatment and/or prevention of an immune disorder. As described herein, the bacterial compositions can be used for at least 8 weeks, for example, the bacterial compositions can be used for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The bacterial composition is prepared as a solid dosage form (also referred to as a solid dose form), such as a capsule. In some embodiments, the solid dosage form is enteric coated. In some embodiments, the enteric coating is at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dose form (e.g., per capsule (e.g., between about 5 mg to about 31 mg per size 0 capsule)). In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² (e.g., about 5 mg per size 0 capsule); about 1.7 mg/cm² (e.g., about 9 mg per size 0 capsule); about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule); about 3.7 mg/cm² (e.g., about 19 mg per size 0 capsule); about 4.8 mg/cm² (e.g., about 25 mg per size 0 capsule); or about 6 mg/cm² (e.g., about 31 mg per size 0 capsule) per solid dose form (such as a capsule).

[3] In some aspects, provided herein are bacterial compositions (e.g., pharmaceutical compositions) comprising Prevotella histicola useful for the treatment and/or prevention of psoriasis (e.g., mild to moderate psoriasis, or mild, moderate, or severe psoriasis) (e.g., in a subject, e.g., a human subject) and methods of using such bacterial compositions (e.g., for the treatment of psoriasis, for the reduction of Lesion Severity Scores (LSS), and/or for the reduction of Psoriasis Area Severity Index (PASI) scores). In some embodiments, the bacterial compositions comprise whole Prevotella histicola bacteria (e.g., live bacteria, non-live bacteria, killed bacteria, and/or attenuated bacteria). As described herein, the bacterial compositions can be used for at least 8 weeks, for example, the bacterial compositions can be used for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The bacterial composition is prepared as a solid dosage form (also referred to as a solid dose form), such as a capsule. In some embodiments, the solid dosage form is enteric coated. In some embodiments, the enteric coating is at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dose form (e.g., per capsule (e.g., between about 5 mg to about 31 mg per size 0 capsule)). In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² (e.g., about 5 mg per size 0 capsule); about 1.7 mg/cm² (e.g., about 9 mg per size 0 capsule); about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule); about 3.7 mg/cm² (e.g., about 19 mg per size 0 capsule); about 4.8 mg/cm² (e.g., about 25 mg per size 0 capsule); or about 6 mg/cm² (e.g., about 31 mg per size 0 capsule) per solid dose form (such as a capsule).

[4] In some aspects, provided herein are bacterial compositions (e.g., pharmaceutical compositions) comprising Prevotella histicola useful for the treatment and/or prevention of atopic dermatitis (e.g., mild to moderate atopic dermatitis, or mild, moderate, or severe atopic dermatitis) (e.g., in a subject, e.g., a human subject) and methods of using such bacterial compositions (e.g., for the treatment of atopic dermatitis and/or for an improvement in EASI score). In some embodiments, the bacterial compositions comprise whole Prevotella histicola bacteria (e.g., live bacteria, non-live bacteria, killed bacteria, and/or attenuated bacteria). As described herein, the bacterial compositions can be used for at least 8 weeks, for example, the bacterial compositions can be used for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The bacterial composition is prepared as a solid dosage form (also referred to as a solid dose form), such as a capsule. In some embodiments, the solid dosage form is enteric coated. In some embodiments, the enteric coating is at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dose form (e.g., per capsule (e.g., between about 5 mg to about 31 mg per size 0 capsule)). In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² (e.g., about 5 mg per size 0 capsule); about 1.7 mg/cm² (e.g., about 9 mg per size 0 capsule); about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule); about 3.7 mg/cm² (e.g., about 19 mg per size 0 capsule); about 4.8 mg/cm² (e.g., about 25 mg per size 0 capsule); or about 6 mg/cm² (e.g., about 31 mg per size 0 capsule) per solid dose form (such as a capsule).

[5] In some aspects, provided herein are bacterial compositions (e.g., pharmaceutical compositions) comprising Prevotella histicola useful for the treatment and/or prevention of psoriatic arthritis (e.g., mild to moderate psoriatic arthritis, or mild, moderate, or severe psoriatic arthritis) (e.g., in a subject, e.g., a human subject) and methods of using such bacterial compositions (e.g., for the treatment of psoriatic arthritis). In some embodiments, the bacterial compositions comprise whole Prevotella histicola bacteria (e.g., live bacteria, non-live bacteria, killed bacteria, and/or attenuated bacteria). As described herein, the bacterial compositions can be used for at least 8 weeks, for example, the bacterial compositions can be used for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The bacterial composition is prepared as a solid dosage form (also referred to as a solid dose form), such as a capsule. In some embodiments, the solid dosage form is enteric coated. In some embodiments, the enteric coating is at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dose form (e.g., per capsule (e.g., between about 5 mg to about 31 mg per size 0 capsule)). In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² (e.g., about 5 mg per size 0 capsule); about 1.7 mg/cm² (e.g., about 9 mg per size 0 capsule); about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule); about 3.7 mg/cm² (e.g., about 19 mg per size 0 capsule); about 4.8 mg/cm² (e.g., about 25 mg per size 0 capsule); or about 6 mg/cm² (e.g., about 31 mg per size 0 capsule) per solid dose form (such as a capsule).

[6] In some aspects, provided herein are bacterial compositions e.g., pharmaceutical compositions) comprising Prevotella histicola useful for the treatment and/or prevention of an autoimmune disease, (e.g., in a subject, e.g., a human subject) and methods of using such bacterial compositions (e.g., for the treatment of an autoimmune disease). In some embodiments, the bacterial compositions comprise whole Prevotella histicola bacteria (e.g., live bacteria, non-live bacteria, killed bacteria, and/or attenuated bacteria). As described herein, the bacterial compositions can be used for at least 8 weeks, for example, the bacterial compositions can be used for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The bacterial composition is prepared as a solid dosage form (also referred to as a solid dose form), such as a capsule. In some embodiments, the solid dosage form is enteric coated. In some embodiments, the enteric coating is at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dose form (e.g., per capsule (e.g., between about 5 mg to about 31 mg per size 0 capsule)). In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² (e.g., about 5 mg per size 0 capsule); about 1.7 mg/cm² (e.g., about 9 mg per size 0 capsule); about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule); about 3.7 mg/cm² (e.g., about 19 mg per size 0 capsule); about 4.8 mg/cm² (e.g., about 25 mg per size 0 capsule); or about 6 mg/cm² (e.g., about 31 mg per size 0 capsule) per solid dose form (such as a capsule).

[7] In some aspects, provided herein are bacterial compositions e.g., pharmaceutical compositions) comprising Prevotella histicola useful for the treatment and/or prevention of an inflammatory disease, (e.g., in a subject, e.g., a human subject) and methods of using such bacterial compositions (e.g., for the treatment of an inflammatory disease). In some embodiments, the bacterial compositions comprise whole Prevotella histicola bacteria (e.g., live bacteria, non-live bacteria, killed bacteria, and/or attenuated bacteria). As described herein, the bacterial compositions can be used for at least 8 weeks, for example, the bacterial compositions can be used for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The bacterial composition is prepared as a solid dosage form (also referred to as a solid dose form), such as a capsule. In some embodiments, the solid dosage form is enteric coated. In some embodiments, the enteric coating is at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dose form (e.g., per capsule (e.g., between about 5 mg to about 31 mg per size 0 capsule)). In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² (e.g., about 5 mg per size 0 capsule); about 1.7 mg/cm² (e.g., about 9 mg per size 0 capsule); about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule); about 3.7 mg/cm² (e.g., about 19 mg per size 0 capsule); about 4.8 mg/cm² (e.g., about 25 mg per size 0 capsule); or about 6 mg/cm² (e.g., about 31 mg per size 0 capsule) per solid dose form (such as a capsule).

[8] In some aspects, provided herein are bacterial compositions (e.g., pharmaceutical compositions) comprising Prevotella histicola useful for the treatment and/or prevention of a metabolic disease, (e.g., in a subject, e.g., a human subject) and methods of using such bacterial compositions (e.g., for the treatment of a metabolic disease). In some embodiments, the bacterial compositions comprise whole Prevotella histicola bacteria (e.g., live bacteria, non-live bacteria, killed bacteria, attenuated and/or bacteria). As described herein, the bacterial compositions can be used for at least 8 weeks, for example, the bacterial compositions can be used for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The bacterial composition is prepared as a solid dosage form (also referred to as a solid dose form), such as a capsule. In some embodiments, the solid dosage form is enteric coated. In some embodiments, the enteric coating is at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dose form (e.g., per capsule (e.g., between about 5 mg to about 31 mg per size 0 capsule)). In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² (e.g., about 5 mg per size 0 capsule); about 1.7 mg/cm² (e.g., about 9 mg per size 0 capsule); about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule); about 3.7 mg/cm² (e.g., about 19 mg per size 0 capsule); about 4.8 mg/cm² (e.g., about 25 mg per size 0 capsule); or about 6 mg/cm² (e.g., about 31 mg per size 0 capsule) per solid dose form (such as a capsule).

[9] In some aspects, provided herein are bacterial compositions (e.g., pharmaceutical compositions) comprising Prevotella histicola useful for the treatment and/or prevention of a dysbiosis, (e.g., in a subject, e.g., a human subject) and methods of using such bacterial compositions (e.g., for the treatment of a dysbiosis). In some embodiments, the bacterial compositions comprise whole Prevotella histicola bacteria (e.g., live bacteria, non-live bacteria, killed bacteria, and/or attenuated bacteria). As described herein, the bacterial compositions can be used for at least 8 weeks, for example, the bacterial compositions can be used for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The bacterial composition is prepared as a solid dosage form (also referred to as a solid dose form), such as a capsule. In some embodiments, the solid dosage form is enteric coated. In some embodiments, the enteric coating is at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dose form (e.g., per capsule (e.g., between about 5 mg to about 31 mg per size 0 capsule)). In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² (e.g., about 5 mg per size 0 capsule); about 1.7 mg/cm² (e.g., about 9 mg per size 0 capsule); about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule); about 3.7 mg/cm² (e.g., about 19 mg per size 0 capsule); about 4.8 mg/cm² (e.g., about 25 mg per size 0 capsule); or about 6 mg/cm² (e.g., about 31 mg per size 0 capsule) per solid dose form (such as a capsule).

[10] In some aspects, provided herein are bacterial compositions (e.g., pharmaceutical compositions) comprising Prevotella histicola useful for decreasing inflammatory cytokine expression (e.g., decreased IL-8, IL-6, IL-ip, and/or TNFa expression levels), (e.g., in a subject, e.g., a human subject) and methods of using such bacterial compositions (e.g., for decreasing inflammatory cytokine expression (e.g., decreased IL-8, IL-6, IL-ip, and/or TNFa expression levels)). In some embodiments, the bacterial compositions comprise whole Prevotella histicola bacteria (e.g., live bacteria, non-live bacteria, killed bacteria, and/or attenuated bacteria). As described herein, the bacterial compositions can be used for at least 8 weeks, for example, the bacterial compositions can be used for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The bacterial composition is prepared as a solid dosage form (also referred to as a solid dose form), such as a capsule. In some embodiments, the solid dosage form is enteric coated. In some embodiments, the enteric coating is at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dose form (e.g., per capsule (e.g., between about 5 mg to about 31 mg per size 0 capsule)). In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² (e.g., about 5 mg per size 0 capsule); about 1.7 mg/cm² (e.g., about 9 mg per size 0 capsule); about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule); about 3.7 mg/cm² (e.g., about 19 mg per size 0 capsule); about 4.8 mg/cm² (e.g., about 25 mg per size 0 capsule); or about 6 mg/cm² (e.g., about 31 mg per size 0 capsule) per solid dose form (such as a capsule).

[11] In some aspects, provided herein are bacterial compositions (e.g., pharmaceutical compositions) comprising Prevotella histicola useful for decreasing IgE levels (e.g., mRNA or protein levels) (e.g., in a subject, e.g., a human subject), and methods of using such bacterial compositions (e.g., for decreasing IgE levels (e.g., mRNA or protein levels)). In some embodiments, the bacterial compositions comprise whole Prevotella histicola bacteria (e.g., live bacteria, non-live bacteria, killed bacteria, and/or attenuated bacteria). As described herein, the bacterial compositions can be used for at least 8 weeks, for example, the bacterial compositions can be used for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The bacterial composition is prepared as a solid dosage form (also referred to as a solid dose form), such as a capsule. In some embodiments, the solid dosage form is enteric coated. In some embodiments, the enteric coating is at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dose form (e.g., per capsule (e.g., between about 5 mg to about 31 mg per size 0 capsule)). In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² (e.g., about 5 mg per size 0 capsule); about 1.7 mg/cm² (e.g., about 9 mg per size 0 capsule); about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule); about 3.7 mg/cm² (e.g., about 19 mg per size 0 capsule); about 4.8 mg/cm² (e.g., about 25 mg per size 0 capsule); or about 6 mg/cm² (e.g., about 31 mg per size 0 capsule) per solid dose form (such as a capsule).

[12] In some aspects, provided herein are bacterial compositions (e.g., pharmaceutical compositions) comprising Prevotella histicola useful for the treatment and/or prevention of bacterial septic shock, cytokine storm and/or viral infection, (e.g., in a subject, e.g., a human subject) and methods of using such bacterial compositions (e.g., for the treatment of bacterial septic shock, cytokine storm and/or viral infection). In some embodiments, the bacterial compositions comprise whole Prevotella histicola bacteria (e.g., live bacteria, non-live bacteria, killed bacteria, and/or attenuated bacteria). As described herein, the bacterial compositions can be used for at least 8 weeks, for example, the bacterial compositions can be used for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The bacterial composition is prepared as a solid dosage form (also referred to as a solid dose form), such as a capsule. In some embodiments, the solid dosage form is enteric coated. In some embodiments, the enteric coating is at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dose form (e.g., per capsule (e.g., between about 5 mg to about 31 mg per size 0 capsule)). In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² (e.g., about 5 mg per size 0 capsule); about 1.7 mg/cm² (e.g., about 9 mg per size 0 capsule); about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule); about 3.7 mg/cm² (e.g., about 19 mg per size 0 capsule); about 4.8 mg/cm² (e.g., about 25 mg per size 0 capsule); or about 6 mg/cm² (e.g., about 31 mg per size 0 capsule) per solid dose form (such as a capsule).

[13] In some aspects, provided herein are bacterial compositions (e.g., pharmaceutical compositions) comprising Prevotella histicola useful for the treatment and/or prevention of a viral infection, (e.g., in a subject, e.g., a human subject) and methods of using such bacterial compositions (e.g., for the treatment of a viral infection). In some embodiments, the viral infection is a coronavirus infection, an influenza infection, and/or a respiratory syncytial virus infection. In some embodiments, the viral infection is a SARS-CoV-2 infection. In some embodiments, the bacterial compositions comprise whole Pre votella histicola bacteria (e.g., live bacteria, non-live bacteria, killed bacteria, and/or attenuated bacteria). As described herein, the bacterial compositions can be used for at least 8 weeks, for example, the bacterial compositions can be used for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The bacterial composition is prepared as a solid dosage form (also referred to as a solid dose form), such as a capsule. In some embodiments, the solid dosage form is enteric coated. In some embodiments, the enteric coating is at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dose form (e.g., per capsule (e.g., between about 5 mg to about 31 mg per size 0 capsule)). In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² (e.g., about 5 mg per size 0 capsule); about 1.7 mg/cm² (e.g., about 9 mg per size 0 capsule); about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule); about 3.7 mg/cm² (e.g., about 19 mg per size 0 capsule); about 4.8 mg/cm² (e.g., about 25 mg per size 0 capsule); or about 6 mg/cm² (e.g., about 31 mg per size 0 capsule) per solid dose form (such as a capsule). [14] In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² per solid dose form (such as a capsule). In some embodiments, the enteric coating is at a coating level of about 1.7 mg/cm² per solid dose form (such as a capsule). In some embodiments, the enteric coating is at a coating level of about 2.7 mg/cm² per solid dose form (such as a capsule). In some embodiments, the enteric coating is at a coating level of about 3.7 mg/cm² per solid dose form (such as a capsule). In some embodiments, the enteric coating is at a coating level of about 4.8 mg/cm² per solid dose form (such as a capsule). In some embodiments, the enteric coating is at a coating level of about 6 mg/cm² per solid dose form (such as a capsule). In some embodiments, the enteric coating comprises a methacrylic acid ethyl acrylate (MAE) copolymer (1 : 1). In some embodiments, the enteric coating comprises a methacrylic acid ethyl acrylate (MAE) copolymer (1 : 1) such as Eudragit L copolymer, such as Eudragit L 30 D-55. In some embodiments, the enteric coating comprises a methacrylic acid ethyl acrylate (MAE) copolymer (1 :1) such as such as Kollicoat MAE 100P. As provided herein, the enteric coating at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dose form (e.g., per capsule (e.g., between about 5 mg to about 31 mg per size 0 capsule)) results in release of the pharmaceutical agent from the solid dosage form in the small intestine.

[15] In some embodiments, the enteric coating level results in release of the pharmaceutical agent from the solid dosage form beyond the duodenum, for example, downstream of bile duct juncture. In some embodiments, the enteric coating level results in release of the pharmaceutical agent from the solid dosage form in the jejunum. In some embodiments, the enteric coating level results in release of the pharmaceutical agent from the solid dosage form in the ileum. In some embodiments, the enteric coating level results in more release of the pharmaceutical agent from the solid dosage form in the jejunum than in the ileum. In some embodiments, the enteric coating level results in median time from gastric emptying to start of release of the pharmaceutical agent from the solid dosage form of less than about 50 minutes. In some embodiments, the enteric coating level results in median time from gastric emptying to start of release of the pharmaceutical agent from the solid dosage form of between about 15 minutes and about 50 minutes. In some embodiments, the enteric coating level results in a mean time from gastric emptying to release of the pharmaceutical agent from the solid dosage form of about 20 minutes to about 40 minutes. In some embodiments, the enteric coating level results in a median time from gastric emptying to release of the pharmaceutical agent from the solid dosage form of about 15 minutes to about 35 minutes. In some embodiments, the solid dosage form is administered to a subject in a fasted state. In some embodiments, the solid dosage form is administered to a subject in a fed state. As used herein, reference to a coating level amount in milligrams (mg) refers to the milligram weight gain on the solid dosage form as a result of the coating. For example, a coating level of 14 mg on a size 0 capsule indicates that the weight of the capsule increases by 14 mg upon application of the coating.

[16] In some embodiments, the enteric coating comprises a combination of two copolymers (e.g., a first copolymer and a second copolymer). In some embodiments, the combination of two copolymers comprises a combination of a methacrylic acid-ethyl acrylate copolymer (1 : 1) and a poly(methyl acrylate-co-methyl methacrylate-co- methacrylic acid) copolymer. In some embodiments, the combination of two copolymers comprises a combination of a Eudragit L copolymer and a Eudragit FS copolymer. In some embodiments, the combination of two copolymers comprises a combination of a methacrylic acid-ethyl acrylate copolymer (1 : 1) (such as Eudragit L copolymer, such as Eudragit L 30 D-55), and a poly(methyl acrylate-co-methyl methacrylate-co-methacrylic acid) copolymer (such as Eudragit FS copolymer, such as Eudragit FS 30 D). In some embodiments, the ratio of the first copolymer to the second copolymer is between about 100%:0% to about 0%: 100%. In some embodiments, the ratio of the first copolymer to the second copolymer is between about 75%:25% to about 25%:75%. In some embodiments, the ratio of the first copolymer to the second copolymer is about 100%:0; about 75%:25%; about 50%:50%; about 25%:75%; about 17.5%:82.5%; or about 0: 100%. In some embodiments, the first copolymer comprises a Eudragit L copolymer, such as Eudragit L 30 D-55 and the second copolymer comprises a Eudragit FS copolymer, such as Eudragit FS 30 D.

[17] In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola is administered to the subject for at least 8 weeks, for example, the bacterial compositions can be used for at least 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola is administered to the subject for at least 8 weeks. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola is administered to the subject for at least 12 weeks. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola is administered to the subject for at least 16 weeks. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola is administered to the subject for at least 20 weeks. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola is administered to the subject for at least 24 weeks. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola is administered to the subject for at least 28 weeks. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola is administered to the subject for at least 32 weeks. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola is administered to the subject for at least 36 weeks. In some embodiments, bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola is administered to the subject for at least 40 weeks. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola is administered to the subject for at least 44 weeks. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola is administered to the subject for at least 48 weeks. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola is administered to the subject for at least 52 weeks. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola is administered to the subject for at least 56 weeks. For example, in some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola is administered to the subject once daily for the given number of weeks. For example, in some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola is administered to the subject twice daily for the given number of weeks.

[18] In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola is administered to the subject for at least 8 weeks, for example, the bacterial compositions can be used for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola is administered to the subject for 8 weeks. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola is administered to the subject for 12 weeks. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola is administered to the subject for 16 weeks. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola is administered to the subject for 20 weeks. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola is administered to the subject for 24 weeks. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola is administered to the subject for 28 weeks. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola is administered to the subject for 32 weeks. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola is administered to the subject for 36 weeks. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola is administered to the subject for 40 weeks. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola is administered to the subject for 44 weeks. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola is administered to the subject for 48 weeks. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola is administered to the subject for 52 weeks. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola is administered to the subject for 56 weeks. For example, in some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola is administered to the subject once daily for the given number of weeks. For example, in some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola is administered to the subject twice daily for the given number of weeks.

[19] In some embodiments, the Prevotella histicola is Prevotella Strain B 50329 (NRRL accession number B 50329; Strain B). In some embodiments, the Prevotella strain is a strain comprising at least 85%, at least 86%, at least 87%, at least 88%, at least 89%, at least 90%, at least 91%, at least 92%, at least 93%, at least 94%, at least 95%, at least 96%, at least 97%, at least 98%, or at least 99% sequence identity (e.g., at least 99.5% sequence identity, at least 99.6% sequence identity, at least 99.7% sequence identity, at least 99.8% sequence identity, at least 99.9% sequence identity) to the nucleotide sequence (e.g., genomic sequence, 16S sequence, CRISPR sequence) of the Prevotella Strain B 50329. [20] In some embodiments, the bacterial composition comprises one strain of bacteria, wherein the one strain of bacteria is a strain comprising at least 99.9% sequence identity to the nucleotide sequence of the Prevotella histicola Strain B 50329 (NRRL accession number B 50329). In some embodiments, the bacterial composition comprises one strain of bacteria, wherein the one strain of bacteria is the Prevotella histicola Strain B 50329 (NRRL accession number B 50329).

[21] In some embodiments, provided herein are solid dosage forms comprising the Prevotella histicola bacteria. In some embodiments, the solid dosage form comprises an enteric coating. In some embodiments, the enteric coating is at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dose form (e.g., per capsule (e.g., between about 5 mg to about 31 mg per size 0 capsule)). In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² (e.g., about 5 mg per size 0 capsule); about 1.7 mg/cm² (e.g., about 9 mg per size 0 capsule); about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule); about 3.7 mg/cm² (e.g., about 19 mg per size 0 capsule); about 4.8 mg/cm² (e.g., about 25 mg per size 0 capsule); or about 6 mg/cm² (e.g., about 31 mg per size 0 capsule) per solid dose form (such as a capsule). In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² per solid dose form (such as a capsule). In some embodiments, the enteric coating is at a coating level of about 1.7 mg/cm² per solid dose form (such as a capsule). In some embodiments, the enteric coating is at a coating level of about 2.7 mg/cm² per solid dose form (such as a capsule). In some embodiments, the enteric coating is at a coating level of about 3.7 mg/cm² per solid dose form (such as a capsule). In some embodiments, the enteric coating is at a coating level of about 4.8 mg/cm² per solid dose form (such as a capsule).

[22] In some embodiments, the solid dosage form is a tablet, e.g., an enteric coated tablet. In some embodiments, the tablet (e.g., enterically coated tablet) is a 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, or 18 mm tablet. In some embodiments, the tablet (e.g., enterically coated tablet) is a 17mm tablet. In some embodiments, each tablet comprises about 3.2 x 10¹¹ total cells of the Prevotella histicola bacteria. In some embodiments, the solid dosage form is a capsule e.g., an enteric coated capsule. In some embodiments, the capsule is a size 00, size 0, size 1, size 2, size 3, size 4, or size 5 capsule. In some embodiments, the capsule is a size 0 capsule. In some embodiments, each capsule comprises about 8 x 10¹⁰ total cells of the Prevotella histicola bacteria. In some embodiments, each capsule comprises about 1.6 x 10¹¹ total cells of the Prevotella histicola bacteria. In some embodiments, each capsule comprises about 3.2 x 10¹¹ total cells (e.g., 3.35 x 10¹¹ total cells) of the Prevotella histicola bacteria.

[23] In some embodiments, from 1.6 x IO¹⁰ cells to 16 x 10¹¹ cells of the

Prevotella histicola strain are administered to the subject daily, e.g., in a solid dosage form. In some embodiments, from 8 x 10¹¹ cells to 16 x 10¹¹ cells of the Prevotella histicola strain are administered to the subject daily, e.g., in a solid dosage form. In some embodiments, from 8 x IO¹⁰ cells to 8 x 10¹¹ cells of the Prevotella histicola strain are administered to the subject daily, e.g., in a solid dosage form. In some embodiments, from 3.2 x IO¹⁰ cells to 9.6 x IO¹⁰ cells of the Prevotella histicola strain are administered to the subject daily, e.g., in a solid dosage form. In some embodiments, from 4.8 x IO¹⁰ cells to

9.6 x IO¹⁰ cells of the Prevotella histicola strain are administered to the subject daily, e.g., in a solid dosage form. In some embodiments, from 6.4 x IO¹⁰ cells to 9.6 x IO¹⁰ cells of the Prevotella histicola strain are administered to the subject daily, e.g., in a solid dosage form. In some embodiments, from 8 x IO¹⁰ cells to 1.6 x 10¹¹ cells of the Prevotella histicola strain are administered to the subject daily, e.g., in a solid dosage form. In some embodiments, from 1.6 x 10¹¹ cells to 8 x 10¹¹ cells of the Prevotella histicola strain are administered to the subject daily, e.g., in a solid dosage form. In some embodiments, about 8 x IO¹⁰ cells of the Prevotella histicola strain are administered to the subject daily, e.g., in a solid dosage form. In some embodiments, about 1.6 x 10¹¹ cells of the Prevotella histicola strain are administered to the subject daily, e.g., in a solid dosage form. In some embodiments, about 3.2 x 10¹¹ cells of the Prevotella histicola strain are administered to the subject daily, e.g., in a solid dosage form. In some embodiments, about 6.4 x 10¹¹ cells of the Prevotella histicola strain are administered to the subject daily, e.g., in a solid dosage form. In some embodiments, about 8 x 10¹¹ cells of the Prevotella histicola strain are administered to the subject daily, e.g., in a solid dosage form. In some embodiments, about

1.6 x 10¹¹ cells of the Prevotella histicola strain are administered to the subject once daily, e.g., in a solid dosage form. In some embodiments, about 1.6 x 10¹¹ cells of the Prevotella histicola strain are administered to the subject twice daily, e.g., in a solid dosage form. In some embodiments, about 1.6 x 10¹¹ cells of the Prevotella histicola strain are administered to the subject twice daily (e.g., for 1-7 days, 3 days, 7 days, 10 days, or 14 days), and then about 1.6 x 10¹¹ cells of the Prevotella histicola strain are administered to the subject once daily, e.g., for the duration of the treatment period (e.g., up to 14 days of total treatment), e.g., in a solid dosage form. [24] In some embodiments, about 8 x IO¹⁰ total cells of the Prevotella histicola strain (e.g., in a solid dosage form) are administered to the subject daily.

[25] In some embodiments, about 1.6 x 10¹¹ total cells of the Prevotella histicola strain (e.g., in a solid dosage form) are administered to the subject daily.

[26] In some embodiments, about 3.2 x 10¹¹ total cells of the Prevotella histicola strain (e.g., in a solid dosage form) are administered to the subject daily.

[27] In some embodiments, about 6.4 x 10¹¹ total cells of the Prevotella histicola strain (e.g., in a solid dosage form) are administered to the subject daily.

[28] In some embodiments, about 9.6 x 10¹¹ total cells of the Prevotella histicola strain (e.g., in a solid dosage form) are administered to the subject daily.

[29] In some embodiments, about 12.8 x 10¹¹ total cells of the Prevotella histicola strain (e.g., in a solid dosage form) are administered to the subject daily.

[30] In some embodiments, about 16 x 10¹¹ total cells of the Prevotella histicola strain (e.g., in a solid dosage form) are administered to the subject daily.

[31] In some embodiments, about 3.2 x IO¹⁰ to about 9.6 x IO¹⁰ total cells of the Prevotella histicola strain (e.g., in a solid dosage form) are administered to the subject daily.

[32] In some embodiments, about 4.8 x IO¹⁰ to about 9.6 x IO¹⁰ total cells of the Prevotella histicola strain (e.g., in a solid dosage form) are administered to the subject daily.

[33] In some embodiments, about 6.4 x IO¹⁰ to about 9.6 x IO¹⁰ total cells of the Prevotella histicola strain (e.g., in a solid dosage form) are administered to the subject daily.

[34] In some embodiments, about 1.6 x 10¹¹ to about 6.4 x 10¹¹ total cells of the Prevotella histicola strain (e.g., in a solid dosage form) are administered to the subject daily.

[35] In some embodiments, about 8 x IO¹⁰ to about 8 x 10¹¹ total cells of the Prevotella histicola strain (e.g., in a solid dosage form) are administered to the subject daily.

[36] In some embodiments, about 9.6 x 10¹¹ to about 16 x 10¹¹ total cells of the Prevotella histicola strain (e.g., in a solid dosage form) are administered to the subject daily.

[37] In some embodiments, about 9.6 x 10¹¹ to about 12.8 x 10¹¹ total cells of the Prevotella histicola strain are administered to the subject daily. [38] In some embodiments, about 12.8 x 10¹¹ to about 16 x 10¹¹ total cells of the Prevotella histicola strain (e.g., in a solid dosage form) are administered to the subject daily.

[39] In some embodiments, the bacterial composition comprises about 1.6 x IO¹⁰ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329 (e.g., in a solid dosage form).

[40] In some embodiments, the bacterial composition comprises about 8 x IO¹⁰ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329 (e.g., in a solid dosage form).

[41] In some embodiments, the bacterial composition comprises about 1.6 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329 (e.g., in a solid dosage form).

[42] In some embodiments, the bacterial composition comprises about 3.2 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329 (e.g., in a solid dosage form).

[43] In some embodiments, the bacterial composition comprises about 6.4 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329 (e.g., in a solid dosage form).

[44] In some embodiments, the bacterial composition comprises about 8 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329 (e.g., in a solid dosage form).

[45] In some embodiments, the bacterial composition comprises about 3.2 x 10¹⁰ to about

9.6 x 10¹⁰ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329 (e.g., in a solid dosage form).

[46] In some embodiments, the bacterial composition comprises about 4.8 x 10¹⁰ to about

[47] In some embodiments, the bacterial composition comprises about 6.4 x 10¹⁰ to about

[48] In some embodiments, the bacterial composition comprises about 1.6 x 10¹⁰ to about 8 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329 (e.g., in a solid dosage form). [49] In some embodiments, the bacterial composition comprises about 1.6 x IO¹⁰ to about 16 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329 (e.g., in a solid dosage form).

[50] In some embodiments, the bacterial composition comprises about 1.6 x IO¹⁰ to about 1.6 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329 (e.g., in a solid dosage form).

[51] In some embodiments, the bacterial composition comprises about 1.6 x 10¹¹ to about 8 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329 (e.g., in a solid dosage form).

[52] In some embodiments, the bacterial composition comprises about 1.6 x 10¹¹ to about 6.4 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329 (e.g., in a solid dosage form).

[53] In some embodiments, the bacterial composition comprises about 8 x 10¹⁰ to about 8 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329 (e.g., in a solid dosage form).

[54] In some embodiments, the bacterial composition is provided as a solid dosage form (also referred to as a solid dose form). In some embodiments, provided herein are solid dosage forms comprising the Prevotella bacteria. In some embodiments, the solid dosage form comprises an enteric coating (e.g., HPMC coat).

[55] In some embodiments, the solid dosage form comprises between about 3.2 x 10¹⁰ and about 9.6 x 10¹⁰ total cells of the Prevotella bacteria (e.g., total dose of a solid dosage form or plurality of solid dosage forms).

[56] In some embodiments, the solid dosage form comprises between about 4.8 x 10¹⁰ and about 9.6 x 10¹⁰ total cells of the Prevotella bacteria (e.g., total dose of a solid dosage form or plurality of solid dosage forms).

[57] In some embodiments, the solid dosage form comprises between about 6.4 x 10¹⁰ and about 9.6 x 10¹⁰ total cells of the Prevotella bacteria (e.g., total dose of a solid dosage form or plurality of solid dosage forms).

[58] In some embodiments, the solid dosage form comprises between about 8 x 10¹⁰ and about 3.2 x 10ⁿtotal cells of the Prevotella bacteria (e.g., total dose of a solid dosage form or plurality of solid dosage forms). [59] In some embodiments, the solid dosage form comprises about 8 x IO¹⁰ total cells of the Prevotella bacteria (e.g., total dose of a solid dosage form or plurality of solid dosage forms).

[60] In some embodiments, the solid dosage form comprises about 1.6 x 10¹¹ total cells of the Prevotella bacteria (e.g., total dose of a solid dosage form or plurality of solid dosage forms).

[61] In some embodiments, the solid dosage form comprises about 3.2 x 10¹¹ total cells of the Prevotella bacteria (e.g., total dose of a solid dosage form or plurality of solid dosage forms).

[62] In some embodiments, the solid dosage form comprises about 6.4 x 10¹¹ total cells of the Prevotella bacteria (e.g., total dose of a solid dosage form or plurality of solid dosage forms).

[63] In some embodiments, the solid dosage form comprises about 8 x 10¹¹ total cells of the Prevotella bacteria (e.g., total dose of a solid dosage form or plurality of solid dosage forms).

[64] In some embodiments, the solid dosage form comprises about 9.6 x 10¹¹ total cells of the Prevotella bacteria (e.g., total dose of a solid dosage form or plurality of solid dosage forms).

[65] In some embodiments, the solid dosage form comprises about 12.8 x 10¹¹ total cells of the Prevotella bacteria (e.g., total dose of a solid dosage form or plurality of solid dosage forms).

[66] In some embodiments, the solid dosage form comprises about 16 x 10¹¹ total cells of the Prevotella bacteria (e.g., total dose of a solid dosage form or plurality of solid dosage forms).

[67] In some embodiments, the solid dosage form comprises a capsule. In some embodiments, the capsule is an enteric coated capsule. In some embodiments, the enteric coating comprises HPMC. In some embodiments, the enteric coating comprises a polymethacrylate-based copolymer. In some embodiments, the enteric coating comprises a methacrylic acid ethyl acrylate (MAE) copolymer (1 : 1). In some embodiments, the enteric coating comprises methacrylic acid ethyl acrylate (MAE) copolymer (1 : 1) such as Kollicoat MAE 100P or a Eudragit L copolymer, such as Eudragit L 30 D-55.

[68] In some embodiments, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 capsules are administered, e.g., once or twice daily to a subject. In some embodiments, 1 capsule is administered, e.g., once or twice daily to a subject. In some embodiments, 2 capsules are administered, e.g., once or twice daily to a subject.

[69] In some embodiments, the Prevotella bacteria in the capsule are lyophilized (e.g., in a powder). In some embodiments, the Prevotella bacteria in the capsule are lyophilized in a powder, and the powder further comprises mannitol, magnesium stearate, and/or colloidal silicon dioxide.

[70] In some embodiments, the capsule comprises about 8 x IO¹⁰ total cells of the Prevotella bacteria (e.g., total dose of a capsule or plurality of capsules).

[71] In some embodiments, the capsule comprises about 1.6 x 10¹¹ total cells of the Prevotella bacteria (e.g., total dose of a capsule or plurality of capsules).

[72] In some embodiments, the capsule comprises about 3.2 x 10¹¹ total cells of the Prevotella bacteria (e.g., total dose of a capsule or plurality of capsules).

[73] In some embodiments, the capsule comprises about 6.4 x 10¹¹ total cells of the Prevotella bacteria (e.g., total dose of a capsule or plurality of capsules).

[74] In some embodiments, the capsule comprises about 8 x 10¹¹ total cells of the Prevotella bacteria (e.g., total dose of a capsule or plurality of capsules).

[75] In some embodiments, the capsule comprises about 9.6 x 10¹¹ total cells of the Prevotella bacteria (e.g., total dose of a capsule or plurality of capsules).

[76] In some embodiments, the capsule comprises about 12.8 x 10¹¹ total cells of the Prevotella bacteria (e.g., total dose of a capsule or plurality of capsules).

[77] In some embodiments, the capsule comprises about 16 x 10¹¹ total cells of the Prevotella bacteria (e.g., total dose of a capsule or plurality of capsules).

[78] In some embodiments, each capsule comprises about 1.6 x IO¹⁰ total cells of the Prevotella bacteria. In some embodiments, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 capsules are administered, e.g., once or twice daily to a subject. In some embodiments, 1 capsule (e.g., comprising about 1.6 x IO¹⁰ total cells) is administered, e.g., once or twice daily to a subject. In some embodiments, 2 capsules (e.g., each comprising about 1.6 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 3 capsules (e.g., each comprising about 1.6 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 4 capsules (e.g., each comprising about 1.6 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 5 capsules (e.g., each comprising about 1.6 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 6 capsules (e.g., each comprising about 1.6 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 8 capsules (e.g., each comprising about 1.6 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 10 capsules (e.g., each comprising about 1.6 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject.

[79] In some embodiments, each capsule comprises about 8 x IO¹⁰ total cells of the Prevotella bacteria. In some embodiments, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 capsules are administered, e.g., once or twice daily to a subject. In some embodiments, 1 capsule (e.g., comprising about 8 x IO¹⁰ total cells) is administered, e.g., once or twice daily to a subject. In some embodiments, 2 capsules (e.g., each comprising about 8 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 3 capsules (e.g., each comprising about 8 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 4 capsules (e.g., each comprising about 8 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 5 capsules (e.g., each comprising about 8 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 6 capsules (e.g., each comprising about 8 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 8 capsules (e.g., each comprising about 8 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 10 capsules (e.g., each comprising about 8 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject.

[80] In some embodiments, each capsule comprises about 1.6 x 10¹¹ total cells of the Prevotella bacteria. In some embodiments, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 capsules are administered, e.g., once or twice daily to a subject. In some embodiments, 1 capsule (e.g., comprising about 1.6 x 10¹¹ total cells) is administered, e.g., once or twice daily to a subject. In some embodiments, 2 capsules (e.g., each comprising about 1.6 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 3 capsules (e.g., each comprising about 1.6 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 4 capsules (e.g., each comprising about 1.6 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 5 capsules (e.g., each comprising about 1.6 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 6 capsules (e.g., each comprising about 1.6 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 8 capsules (e.g., each comprising about 1.6 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 10 capsules (e.g., each comprising about 1.6 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject.

[81] In some embodiments, each capsule comprises about 3.2 x 10¹¹ total cells of the Prevotella bacteria. In some embodiments, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 capsules are administered, e.g., once or twice daily to a subject. In some embodiments, 1 capsule (e.g., comprising about 3.2 x 10¹¹ total cells) is administered, e.g., once or twice daily to a subject. In some embodiments, 2 capsules (e.g., each comprising about 3.2 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 3 capsules (e.g., each comprising about 3.2 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 4 capsules (e.g., each comprising about 3.2 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 5 capsules (e.g., each comprising about 3.2 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 6 capsules (e.g., each comprising about 3.2 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 8 capsules (e.g., each comprising about 3.2 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 10 capsules (e.g., each comprising about 3.2 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject.

[82] In some embodiments, the solid dosage form comprises a tablet. In some embodiments, the tablet is an enteric coated tablet. In some embodiments, the tablet is from 5mm to 18mm in diameter. In some embodiments, the enteric coating comprises HPMC. In some embodiments, the enteric coating comprises a polymethacrylate-based copolymer. In some embodiments, the enteric coating comprises a methacrylic acid ethyl acrylate (MAE) copolymer (1 : 1). In some embodiments, the enteric coating comprises methacrylic acid ethyl acrylate (MAE) copolymer (1 : 1) (such as Kollicoat MAE 100P).

[83] In some embodiments, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 tablets are administered, e.g., once or twice daily to a subject. In some embodiments, 1 tablet is administered, e.g., once or twice daily to a subject. In some embodiments, 2 tablets are administered, e.g., once or twice daily to a subject.

[84] In some embodiments, the Prevotella bacteria in the tablet are lyophilized. In some embodiments, the Prevotella bacteria in the tablet are lyophilized (e.g., in a powder). In some embodiments, the Prevotella bacteria in the tablet are lyophilized in a powder, and the powder further comprises mannitol, magnesium stearate, and/or colloidal silicon dioxide.

[85] In some embodiments, the tablet comprises about 8 x IO¹⁰ total cells of the Prevotella bacteria (e.g., total dose of a tablet or plurality of tablets).

[86] In some embodiments, the tablet comprises about 1.6 x 10¹¹ total cells of the Prevotella bacteria (e.g., total dose of a tablet or plurality of tablets).

[87] In some embodiments, the tablet comprises about 3.2 x 10¹¹ total cells of the Prevotella bacteria (e.g., total dose of a tablet or plurality of tablets).

[88] In some embodiments, the tablet comprises about 6.4 x 10¹¹ total cells of the Prevotella bacteria (e.g., total dose of a tablet or plurality of tablets).

[89] In some embodiments, the tablet comprises about 8 x 10¹¹ total cells of the Prevotella bacteria (e.g., total dose of a tablet or plurality of tablets).

[90] In some embodiments, the tablet comprises about 9.6 x 10¹¹ total cells of the Prevotella bacteria (e.g., total dose of a tablet or plurality of tablets).

[91] In some embodiments, the tablet comprises about 12.8 x 10¹¹ total cells of the Prevotella bacteria (e.g., total dose of a tablet or plurality of tablets).

[92] In some embodiments, the tablet comprises about 16 x 10¹¹ total cells of the Prevotella bacteria (e.g., total dose of a tablet or plurality of tablets).

[93] In some embodiments, each tablet comprises about 8 x IO¹⁰ total cells of the Prevotella bacteria. In some embodiments, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 tablets are administered, e.g., once or twice daily to a subject. In some embodiments, 1 tablet (e.g., comprising about 8 x IO¹⁰ total cells) is administered, e.g., once or twice daily to a subject. In some embodiments, 2 tablets (e.g., each comprising about 8 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 3 tablets (e.g., each comprising about 8 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 4 tablets (e.g., each comprising about 8 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 5 tablets (e.g., each comprising about 8 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 6 tablets (e.g., each comprising about 8 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 8 tablets (e.g., each comprising about 8 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 10 tablets (e.g., each comprising about 8 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. [94] In some embodiments, each tablet comprises about 1.6 x 10¹¹ total cells of the Prevotella bacteria. In some embodiments, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 tablets are administered, e.g., once or twice daily to a subject. In some embodiments, 1 tablet (e.g., comprising about 1.6 x 10¹¹ total cells) is administered, e.g., once or twice daily to a subject. In some embodiments, 2 tablets (e.g., each comprising about 1.6 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 3 tablets (e.g., each comprising about 1.6 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 4 tablets (e.g., each comprising about 1.6 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 5 tablets (e.g., each comprising about 1.6 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 6 tablets (e.g., each comprising about 1.6 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 8 tablets (e.g., each comprising about 1.6 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 10 tablets (e.g., each comprising about 1.6 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject.

[95] In some embodiments, each tablet comprises about 3.2 x 10ⁿtotal cells of the Prevotella bacteria. In some embodiments, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 tablets are administered, e.g., once or twice daily to a subject. In some embodiments, 1 tablet (e.g., comprising about 3.2 x 10¹¹ total cells) is administered, e.g., once or twice daily to a subject. In some embodiments, 2 tablets (e.g., each comprising about 3.2 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 3 tablets (e.g., each comprising about 3.2 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 4 tablets (e.g., each comprising about 3.2 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 5 tablets (e.g., each comprising about 3.2 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 6 tablets (e.g., each comprising about 3.2 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 8 tablets (e.g., each comprising about 3.2 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 10 tablets (e.g., each comprising about 3.2 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. [96] In some embodiments, the bacterial composition comprising Pre votella bacteria is prepared as a powder (e.g., for resuspension or for use in a solid dose form (such as a capsule)) or as a solid dose form, such as a tablet, a mini-tablet, a capsule, a pill, or a powder; or a combination of these forms (e.g., mini-tablets comprised in a capsule). The powder can comprise lyophilized bacteria. In some embodiments, the powder further comprises mannitol, magnesium stearate, and/or colloidal silicon dioxide.

[97] In some embodiments, the bacterial composition (e.g., prepared as a solid dosage form) (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 8 x IO¹⁰ total cells of the Prevotella bacteria.

[98] In some embodiments, the bacterial composition (e.g., prepared as a solid dosage form) (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 1.6 x 10¹¹ total cells the Prevotella bacteria.

[99] In some embodiments, the bacterial composition (e.g., prepared as a solid dosage form) (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 3.2 x 10¹¹ total cells the Prevotella bacteria.

[100] In some embodiments, the bacterial composition (e.g., prepared as a solid dosage form) (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 6.4 x 10¹¹ total cells the Prevotella bacteria.

[101] In some embodiments, the bacterial composition (e.g., prepared as a solid dosage form) (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 8 x 10¹¹ total cells of the Prevotella bacteria.

[102] In some embodiments, the bacterial composition (e.g., prepared as a solid dosage form) (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 3.2 x 10¹⁰to about 9.6 x IO¹⁰ total cells of the Prevotella bacteria.

[103] In some embodiments, the bacterial composition (e.g., prepared as a solid dosage form) (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 4.8 x 10¹⁰to about 9.6 x 10¹⁰ total cells of the Prevotella bacteria.

[104] In some embodiments, the bacterial composition (e.g., prepared as a solid dosage form) (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 6.4 x 10¹⁰to about 9.6 x 10¹⁰ total cells of the Prevotella bacteria.

[105] In some embodiments, the bacterial composition (e.g., prepared as a solid dosage form) (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 1.6 x 10¹⁰to about 8 x 10¹¹ total cells of the Prevotella bacteria. [106] In some embodiments, the bacterial composition (e.g., prepared as a solid dosage form) (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 1.6 x 10¹⁰to about 1.6 x 10¹¹ total cells of the Prevotella bacteria.

[107] In some embodiments, the bacterial composition (e.g., prepared as a solid dosage form) (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 1.6 x IO¹⁰ to about 16 x 10¹¹ total cells of the Prevotella bacteria.

[108] In some embodiments, the bacterial composition (e.g., prepared as a solid dosage form) (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 8 x 10¹⁰to about 8 x 10¹¹ total cells of the Prevotella bacteria.

[109] In some embodiments, the bacterial composition (e.g., prepared as a solid dosage form) (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 1.6 x 10¹¹ to about 6.4 x 10¹¹ total cells of the Prevotella bacteria.

[HO] In some embodiments, the bacterial composition (e.g., prepared as a solid dosage form) (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 1.6 x 10¹¹ to about 8 x 10¹¹ total cells of the Prevotella bacteria.

[Hl] In some embodiments, the bacterial composition (e.g., prepared as a solid dosage form) (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 1.6 x 10¹¹ to about 16 x 10¹¹ total cells of the Prevotella bacteria.

[112] In some embodiments, the bacterial composition (e.g., prepared as a solid dosage form) (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 8 x 10¹⁰to about 8 x 10¹¹ total cells of the Prevotella bacteria.

[113] In some embodiments, the bacterial composition (e.g., prepared as a solid dosage form) (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 8 x 10¹⁰ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[114] In some embodiments, the bacterial composition (e.g., prepared as a solid dosage form) (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 1.6 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[115] In some embodiments, the bacterial composition (e.g., prepared as a solid dosage form) (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 3.2 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[116] In some embodiments, the bacterial composition (e.g., prepared as a solid dosage form) (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 6.4 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329. [117] In some embodiments, the bacterial composition (e.g., prepared as a solid dosage form) (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 8 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[118] In some embodiments, the bacterial composition (e.g., prepared as a solid dosage form) (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 9.6 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[119] In some embodiments, the bacterial composition (e.g., prepared as a solid dosage form) (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 12.8 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[120] In some embodiments, the bacterial composition (e.g., prepared as a solid dosage form) (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 16 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[121] In some embodiments, the bacterial composition (e.g., prepared as a solid dosage form) (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 9.6 x 10¹¹ to about 16 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[122] In some embodiments, the bacterial composition (e.g., prepared as a solid dosage form) (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 9.6 x 10¹¹ to about 12.8 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[123] In some embodiments, the bacterial composition (e.g., prepared as a solid dosage form) (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 12.8 x 10¹¹ to about 16 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[124] In some embodiments, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 solid dosage forms are administered, e.g., once or twice daily to a subject.

[125] In some embodiments, the solid dosage form comprises about 8 x 10¹⁰to about 3.2 x 10¹¹ cells per solid dosage form.

[126] In some embodiments, the solid dosage form comprises about 3.2 x 10¹⁰to about 9.6 x 10¹⁰ cells per solid dosage form.

[127] In some embodiments, the solid dosage form comprises about 4.8 x 10¹⁰to about 9.6 x 10¹⁰ cells per solid dosage form. [128] In some embodiments, the solid dosage form comprises about 6.4 x 10¹⁰to about 9.6 x IO¹⁰ cells per solid dosage form.

[129] In some embodiments, the solid dosage form comprises about 1.6xlO¹⁰ cells per solid dosage form.

[130] In some embodiments, the solid dosage form comprises about 8xlO¹⁰ cells per solid dosage form.

[131] In some embodiments, the solid dosage form comprises about 1.6xlOⁿ cells per solid dosage form.

[132] In some embodiments, the solid dosage form comprises about 3.2xlOⁿ cells per solid dosage form.

[133] In some embodiments, one solid dosage form is administered to the subject once daily.

[134] In some embodiments, one solid dosage form is administered to the subject twice daily.

[135] In some embodiments, two solid dosage forms are administered to the subject once daily.

[136] In some embodiments, two solid dosage forms are administered to the subject twice daily.

[137] In some embodiments, three solid dosage forms are administered to the subject once daily.

[138] In some embodiments, three solid dosage forms are administered to the subject twice daily.

[139] In some embodiments, four solid dosage forms are administered to the subject once daily.

[140] In some embodiments, four solid dosage forms are administered to the subject twice daily.

[141] In some embodiments, five solid dosage forms are administered to the subject once daily.

[142] In some embodiments, five solid dosage forms are administered to the subject twice daily.

[143] In some embodiments, 1 solid dosage form (e.g., tablet or capsule) is administered (e.g., is for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 1.6 x IO¹⁰ total cells. In some embodiments, 2 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form (e.g., each solid dose form) comprises a dose of bacteria of about 1.6 x IO¹⁰ total cells. In some embodiments, 3 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 1.6 x IO¹⁰ total cells. In some embodiments, 4 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 1.6 x IO¹⁰ total cells. In some embodiments, 5 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 1.6 x IO¹⁰ total cells. In some embodiments, 6 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 1.6 x IO¹⁰ total cells. In some embodiments, 8 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 1.6 x IO¹⁰ total cells. In some embodiments, 10 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 1.6 x 10¹⁰total cells.

[144] In some embodiments, 1 solid dosage form (e.g., tablet or capsule) is administered (e.g., is for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 8 x IO¹⁰ total cells. In some embodiments, 2 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form (e.g., each solid dose form) comprises a dose of bacteria of about 8 x IO¹⁰ total cells. In some embodiments, 3 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 8 x IO¹⁰ total cells. In some embodiments, 4 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 8 x IO¹⁰ total cells. In some embodiments, 5 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 8 x IO¹⁰ total cells. In some embodiments, 6 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 8 x IO¹⁰ total cells. In some embodiments, 8 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 8 x IO¹⁰ total cells. In some embodiments, 10 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 8 x IO¹⁰ total cells.

[145] In some embodiments, 1 solid dosage form (e.g., tablet or capsule) is administered (e.g., is for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 1.6 x 10¹¹ total cells. In some embodiments, 2 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form (e.g., each solid dose form) comprises a dose of bacteria of about 1.6 x 10¹¹ total cells. In some embodiments, 3 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 1.6 x 10¹¹ total cells. In some embodiments, 4 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 1.6 x 10¹¹ total cells. In some embodiments, 5 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 1.6 x 10¹¹ total cells. In some embodiments, 6 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 1.6 x 10¹¹ total cells. In some embodiments, 8 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 1.6 x 10¹¹ total cells. In some embodiments, 10 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 1.6 x 10¹¹ total cells. [146] In some embodiments, 1 solid dosage form (e.g., tablet or capsule) is administered (e.g., is for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 3.2 x 10¹¹ total cells. In some embodiments, 2 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form (e.g., each solid dose form) comprises a dose of bacteria of about 3.2 x 10¹¹ total cells. In some embodiments, 3 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 3.2 x 10¹¹ total cells. In some embodiments, 4 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 3.2 x 10¹¹ total cells. In some embodiments, 5 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 3.2 x 10ⁿtotal cells. In some embodiments, 6 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 3.2 x 10¹¹ total cells. In some embodiments, 8 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 3.2 x 10¹¹ total cells. In some embodiments, 10 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 3.2 x 10¹¹ total cells. For clarity, about 3.2 x 10¹¹ total cells includes total cell counts within ± 5% of 3.2 x 10¹¹ total cells e.g., 3.35 x 10¹¹ total cells.

[147] In some embodiments, the solid dosage form is a tablet. In some embodiments, the tablet is an enteric coated tablet. In some embodiments, the enteric coated tablet is from 5 mm to 18 mm in diameter. In some embodiments, the tablet (e.g., enterically coated tablet) is a 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, or 18 mm tablet. In some embodiments, the tablet (e.g., enterically coated tablet) is a 17 mm tablet. In some embodiments, the tablet comprises about 8 x IO¹⁰ total cells of the Prevotella bacteria. In some embodiments, the tablet comprises about 1.6 x 10¹¹ total cells of the Prevotella bacteria. In some embodiments, the tablet comprises about 3.2 x 10¹¹ total cells of the Prevotella bacteria. In some embodiments, the Prevotella bacteria in the tablet are lyophilized.

[148] In some embodiments, the solid dosage form is a capsule. In some embodiments, the capsule is an enteric coated capsule. In some embodiments, the capsule (e.g., enteric coated capsule) is a size 00, size 0, size 1, size 2, size 3, size 4, or size 5 capsule. In some embodiments, the capsule is a size 0 capsule. In some embodiments, the capsule comprises about 1.6 x IO¹⁰ total cells of the Prevotella bacteria. In some embodiments, the capsule comprises about 8 x IO¹⁰ total cells of the Prevotella bacteria. In some embodiments, the capsule comprises about 1.6 x 10¹¹ total cells of the Prevotella bacteria. In some embodiments, the capsule comprises about 3.2 x 10¹¹ total cells of the Prevotella bacteria. In some embodiments, the Prevotella bacteria in the capsule are lyophilized.

[149] In some embodiments, provided herein are solid dosage forms comprising the Prevotella bacteria. In some embodiments, the solid dosage form is a tablet, e.g., an enteric coated tablet. In some embodiments, the solid dosage form is a mini-tablet, e.g., an enteric coated mini-tablet. In some embodiments, the solid dosage form is a capsule, e.g., an enteric coated capsule. In some embodiments, the enteric coating comprises a polymethacrylate-based copolymer. In some embodiments, the enteric coating comprises a methacrylic acid ethyl acrylate (MAE) copolymer (1 : 1). In some embodiments, the enteric coating comprises methacrylic acid ethyl acrylate (MAE) copolymer (1 : 1) (such as Kollicoat MAE 100P or Eudragit L30-D55).

[150] In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella bacteria is prepared as a powder. The powder can comprise lyophilized bacteria. In some embodiments, the powder further comprises mannitol, magnesium stearate, and/or colloidal silicon dioxide. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprises a powder comprising Prevotella bacteria. In some embodiments, the powder comprising Prevotella bacteria (e.g., at a dose provided herein) is resuspended (e.g., in a liquid such as a solution, buffer, water or other beverage, or a food), e.g., for use in the methods provided herein.

[151] In some embodiments, the Prevotella histicola strain is administered in a bacterial composition (e.g., pharmaceutical composition) (e.g., a pharmaceutical composition provided herein). In some embodiments the bacterial composition (e.g., pharmaceutical composition) is a solid dose form provided herein. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprises a blend of freeze- dried powder of Prevotella histicola and excipients (e.g., an encapsulated freeze-dried powder of Prevotella histicola strain provided herein and excipients). In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprises freeze-dried (e.g., lyophilized) powder of bacteria in a capsule. In some embodiments, the capsule is enteric coated. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprises an enteric coated hydroxylpropyl methylcellulose (HPMC) hard capsule. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprises a formulation of Prevotella histicola Strain B comprising freeze-dried powder of Prevotella histicola and excipients. In some embodiments, the excipients include mannitol, magnesium stearate and colloidal silicon dioxide. In some embodiments, each capsule contains about 8.0 x 1O¹⁰ cells of a. Prevotella histicola strain provided herein (e.g., Prevotella histicola Strain B). In some embodiments, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 powder-containing capsules are administered to a subject daily. In some embodiments, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 powder-containing capsules (e.g., each containing about 8.0 x 1O¹⁰ cells of a Prevotella histicola strain provided herein (e.g., Prevotella histicola Strain B)) are administered to a subject once daily. In some embodiments, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 powder-containing capsules (e.g., each containing about 8.0 x 1O¹⁰ cells of a Prevotella histicola strain provided herein (e.g., Prevotella histicola Strain B)) are administered to a subject twice daily. In some embodiments, 2 powder-containing capsules are administered to the subject daily. In some embodiments, 1 powder-containing capsule is administered to the subject daily. In some embodiments, each powder-containing capsule contains about 8.0 x io¹⁰ cells of a Prevotella histicola strain provided herein (e.g., Prevotella histicola Strain B). In some embodiments, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 powder-containing capsules are administered to a subject daily. In some embodiments, 2 powder-containing enteric coated capsules (e.g., each containing about 8.0 x 1O¹⁰ cells of a Prevotella histicola strain provided herein (e.g., Prevotella histicola Strain B)) are administered to the subject daily. In some embodiments, 4 powder-containing enteric coated capsules (e.g., each containing about 8.0 x io¹⁰ cells of a Prevotella histicola strain provided herein (e.g., Prevotella histicola Strain B)) are administered to the subject daily. In some embodiments, 2 powder-containing enteric coated capsules (e.g., each containing about 8.0 x 1O¹⁰ cells of a Prevotella histicola strain provided herein (e.g., Prevotella histicola Strain B)) are administered to the subject once daily. In some embodiments, 2 powder-containing enteric coated capsules (e.g., each containing about 8.0 x 1O¹⁰ cells of a Prevotella histicola strain provided herein (e.g., Prevotella histicola Strain B)) are administered to the subject twice daily. In some embodiments, 2 powder-containing enteric coated capsules (e.g., each containing about 8.0 x 1O¹⁰ cells of a Prevotella histicola strain provided herein (e.g., Prevotella histicola Strain B)) are administered to the subject twice daily (e.g., for 1-7 days, 3 days, 7 days, 10 days, or 14 days), and then 2 powder-containing enteric coated capsules (e.g., each containing about 8.0 x 1O¹⁰ cells of a Prevotella histicola strain provided herein (e.g., Prevotella histicola Strain B)) are administered to the subject once daily, e.g., for the duration of the treatment period (e.g., up to 14 days of total treatment). In some embodiments, 1 powder-containing enteric coated capsule (e.g., containing about 8.0 x io¹⁰ cells of a Prevotella histicola strain provided herein (e.g., Prevotella histicola Strain B)) is administered to the subject daily.

[152] In some embodiments, 1 powder-containing enteric coated capsule (e.g., containing about 8.0 x 1O¹⁰ cells of a Prevotella histicola strain provided herein (e.g., Prevotella histicola Strain B)) is administered to the subject daily. In some embodiments, 1 powder-containing enteric coated capsule (e.g., containing about 8.0 x io¹⁰ cells of a Prevotella histicola strain provided herein (e.g., Prevotella histicola Strain B)) is administered to the subject once daily. In some embodiments, 1 powder-containing enteric coated capsule (e.g., containing about 8.0 x 1O¹⁰ cells of a Prevotella histicola strain provided herein (e.g., Prevotella histicola Strain B)) is administered to the subject twice daily.

[153] In some embodiments, 1 powder-containing enteric coated capsule (e.g., containing about 3.2 x 10¹¹ cells of a Prevotella histicola strain provided herein (e.g., Prevotella histicola Strain B)) is administered to the subject daily. In some embodiments, 1 powder-containing enteric coated capsule (e.g., containing about 3.2 x io¹¹ cells of a Prevotella histicola strain provided herein (e.g., Prevotella histicola Strain B)) is administered to the subject once daily. In some embodiments, 1 powder-containing enteric coated capsule (e.g., containing about 3.2 x 10¹¹ cells of a. Prevotella histicola strain provided herein (e.g., Prevotella histicola Strain B)) is administered to the subject twice daily.

[154] In some embodiments, 2 powder-containing enteric coated capsules (e.g., each containing about 8.0 x 1O¹⁰ cells of a Prevotella histicola strain provided herein (e.g., Prevotella histicola Strain B)) are administered to the subject daily. In some embodiments, 2 powder-containing enteric coated capsules (e.g., each containing about 8.0 x io¹⁰ cells of a Prevotella histicola strain provided herein (e.g., Prevotella histicola Strain B)) are administered to the subject once daily. In some embodiments, 2 powder-containing enteric coated capsules (e.g., each containing about 8.0 x 1O¹⁰ cells of a Prevotella histicola strain provided herein (e.g., Prevotella histicola Strain B)) are administered to the subject twice daily.

[155] In some embodiments, 2 powder-containing enteric coated capsules (e.g., each containing about 3.2 x 10¹¹ cells of a Prevotella histicola strain provided herein (e.g., Prevotella histicola Strain B)) are administered to the subject daily. In some embodiments, 2 powder-containing enteric coated capsules (e.g., each containing about 3.2 x io¹¹ cells of a Prevotella histicola strain provided herein (e.g., Prevotella histicola Strain B)) are administered to the subject once daily. In some embodiments, 2 powder-containing enteric coated capsules (e.g., each containing about 3.2 x 10¹¹ cells of a Prevotella histicola strain provided herein (e.g., Prevotella histicola Strain B)) are administered to the subject twice daily.

[156] In some embodiments, the bacterial composition comprising Pre votella bacteria is prepared as a solid dose form, such as a tablet, capsule, or a powder. The powder can comprise lyophilized bacteria. In some embodiments, the powder further comprises mannitol, magnesium stearate, and/or colloidal silicon dioxide. In some embodiments, the bacterial composition comprises a powder comprising Prevotella bacteria. In some embodiments, the powder comprising Prevotella bacteria (e.g., at a dose provided herein) is resuspended (e.g., in a liquid such as a solution, buffer, water or other beverage, or a food), e.g., for use in the methods provided herein.

[157] In some embodiments, the bacterial composition is administered orally. In some embodiments, the solid dosage form is administered to a subject in a fasted state. In some embodiments, the solid dosage form is administered to a subject in a fed state.

[158] In some embodiments, the administration to the subject is once daily. In some embodiments, the administration to the subject is twice daily.

[159] In some embodiments, the bacterial composition is administered once daily for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. In some embodiments, the bacterial composition is administered once daily for at least 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. In some embodiments, the bacterial composition is administered once daily for at least 8 weeks. In some embodiments, the bacterial composition is administered once daily for at least 12 weeks. In some embodiments, the bacterial composition is administered once daily for at least 16 weeks. In some embodiments, the bacterial composition is administered once daily for at least 20 weeks. In some embodiments, the bacterial composition is administered once daily for at least 24 weeks. In some embodiments, the bacterial composition is administered once daily for at least 28 weeks. In some embodiments, the bacterial composition is administered once daily for at least 32 weeks. In some embodiments, the bacterial composition is administered once daily for at least 36 weeks. In some embodiments, the bacterial composition is administered once daily for at least 40 weeks. In some embodiments, the bacterial composition is administered once daily for at least 44 weeks. In some embodiments, the bacterial composition is administered once daily for at least 48 weeks. In some embodiments, the bacterial composition is administered once daily for at least 52 weeks.

[160] In some embodiments, the bacterial composition comprises lyophilized Pre votella bacteria, e.g., in a powder. In some embodiments, the lyophilized Prevotella bacteria is formulated into a solid dose form, such as a tablet or capsule. In some embodiments, the powder further comprises mannitol, magnesium stearate, and/or colloidal silicon dioxide.

[161] In some embodiments, the bacterial composition is formulated as a tablet. In some embodiments, the bacterial formulation (e.g., composition) comprises an enteric coating or micro encapsulation.

[162] In some embodiments, the bacterial composition is formulated as a capsule. In some embodiments, the bacterial formulation (e.g., composition) comprises an enteric coating or micro encapsulation.

[163] In some embodiments, the subject is a mammal. In some embodiments, the subject is a human. In some embodiments, the subject is a non-human mammal (e.g., a dog, a cat, a cow, a horse, a pig, a donkey, a goat, a camel, a mouse, a rat, a guinea pig, a sheep, a llama, a monkey, a gorilla, or a chimpanzee).

[164] In some aspects, the disclosure provides use of a. Prevotella histicola strain provided herein and/or a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein (e.g., in an amount described herein) for the preparation of a medicament for the performance of a therapeutic method provided herein. [165] In some aspects, the disclosure provides a Prevotella histicola strain provided herein and/or a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein (e.g., in an amount described herein) for use in the performance of a therapeutic method provided herein.

[166] In some embodiments, provided herein are methods of treating a subject who has a Thl mediated inflammatory disease comprising administering to the subject a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein.

[167] In some embodiments, provided herein is a method of treating a Thl mediated inflammatory disease comprising administering (e.g., orally administering) to a human subject (e.g., a subject with a Thl mediated inflammatory disease) a strain of a Prevotella histicola and/or a composition (e.g., a bacterial composition (e.g., pharmaceutical composition) and/or a solid dosage form) comprising a strain of a. Prevotella histicola provided herein.

[168] In some embodiments, provided herein are methods of treating a subject who has a Th2 mediated inflammatory disease (such as asthma or atopic dermatitis) comprising administering to the subject a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein.

[169] In some embodiments, provided herein is a method of treating a Th2 mediated inflammatory disease (such as asthma or atopic dermatitis) comprising administering (e.g., orally administering) to a human subject (e.g., a subject with a Th2 mediated inflammatory disease (such as asthma or atopic dermatitis)) a strain of a Prevotella histicola and/or a composition (e.g., a bacterial composition (e.g., pharmaceutical composition) and/or a solid dosage form) comprising a strain of a Prevotella histicola provided herein.

[170] In some embodiments, provided herein are methods of treating a subject who has a Thl7 mediated inflammatory disease (such as psoriasis) comprising administering to the subject a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein.

[171] In some embodiments, provided herein is a method of treating a Thl7 mediated inflammatory disease (such as psoriasis) comprising administering (e.g., orally administering) to a human subject (e.g., a subject with a Thl7 mediated inflammatory disease (such as psoriasis)) a strain of a Prevotella histicola and/or a composition (e.g., a bacterial composition (e.g., pharmaceutical composition) and/or a solid dosage form) comprising a strain of a Prevotella histicola provided herein. [172] In some embodiments, provided herein are methods of treating a subject who has psoriasis (e.g., mild to moderate psoriasis, or mild, moderate, or severe psoriasis) comprising administering to the subject a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein.

[173] In some embodiments, provided herein are methods of decreasing Lesion Severity Score (LSS) (e.g., mean LSS) (e.g., as compared to baseline or placebo control) in a subject (e.g., a subject with psoriasis) comprising administering to the subject a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein. In some embodiments, the LSS in the subject is reduced by at least 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, or more (e.g., by week 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 of treatment). In some embodiments, the LSS in the subject is reduced by at least 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, or more after dosing is stopped (e.g., 24 weeks after treatment has stopped).

[174] In some embodiments, provided herein are methods of decreasing Psoriasis Area and Severity Index (PASI) score (e.g., mean PASI score) (e.g., as compared to baseline or placebo control) in a subject (e.g., a subject with psoriasis) comprising administering to the subject a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein. In some embodiments, the PASI score in the subject is reduced by at least 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, or more (e.g., by week 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 of treatment). In some embodiments, the PASI score in the subject is reduced by at least 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, or more after dosing is stopped (e.g., 24 weeks after treatment has stopped).

[175] In some embodiments, provided herein are methods of increasing a sustained clinical effect (e.g., continued reductions from baseline (or placebo) in mean LSS and/or PASI e.g., as compared to baseline or placebo control), e.g., 24 or more weeks after completion of dosing) in a subject (e.g., a subject with psoriasis) comprising administering to the subject a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein. In some embodiments, the LSS and/or PASI score in the subject is reduced by at least 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, or more (e.g., by week 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 of treatment). [176] In some embodiments, provided herein are methods of enhancing anti-inflammatory cytokine production (e.g., increasing as compared to amount produced (e.g., mRNA and/or protein) in the absence of the bacterial composition) in a subject, the method comprising administering a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein. In some embodiments, the anti-inflammatory cytokine is IL- 10, IL- 27, and/or IL1RA. In some embodiments, the anti-inflammatory cytokine is expressed by Ml -type APCs. In some embodiments, enhancing anti-inflammatory cytokine production comprises an increase in anti-inflammatory cytokine (e.g., IL-10, IL-27, and/or IL1RA) mRNA levels (e.g., in skin biopsies). In some embodiments, enhancing anti-inflammatory cytokine production comprises an increase in anti-inflammatory cytokine (e.g., IL- 10, IL- 27, and/or IL IRA) protein levels (e.g., in blood samples).

[177] In some embodiments, provided herein are methods of inhibiting pro-inflammatory cytokine production (e.g., decreasing as compared to amount produced (e.g., mRNA and/or protein) in the absence of the bacterial composition) in a subject, the method comprising administering a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein. In some embodiments, the pro-inflammatory cytokine is GM-CSF, IL-17A, and/or IL-13. In some embodiments, the pro-inflammatory cytokine is IL-6, TNF, and/or IL-12p70. In some embodiments, the pro-inflammatory cytokine is IL-23p40, IL-17, IL-6, TNF, and/or IL-13. In some embodiments, the pro-inflammatory cytokine is IL-31, IL-23p40, IL- 17, and/or IL-13. In some embodiments, the pro-inflammatory cytokine is IL- 4, IL-5, and/or IL-13. In some embodiments, inhibiting pro-inflammatory cytokine production comprises inhibiting pro-inflammatory cytokine production in a draining lymph node (e.g., cervical lymph node). In some embodiments, inhibiting pro-inflammatory cytokine production comprises inhibiting pro-inflammatory cytokine production in the spleen. In some embodiments, inhibiting pro-inflammatory cytokine production comprises a decrease in pro-inflammatory cytokine (e.g., 1117a) mRNA levels (e.g., in skin biopsies). In some embodiments, inhibiting pro-inflammatory cytokine production comprises a decrease in pro-inflammatory cytokine (e.g., IL-17A) protein levels (e.g., in blood samples).

[178] In some embodiments, provided herein are methods of inhibiting pro-inflammatory chemokines production (e.g., decreasing as compared to amount produced (e.g., mRNA and/or protein) in the absence of the bacterial composition) in a subject, the method comprising administering a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein. In some embodiments, the pro-inflammatory chemokine is keratinocyte chemoattractant (KC).

[179] In some embodiments, provided herein are methods of altering cytokine production or chemokine production (e.g., altering as compared to amount produced (e.g., mRNA and/or protein) in the absence of the bacterial composition) in a subject, the method comprising administering a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein. In some embodiments, blood samples from the subject are stimulated ex vivo and analyzed for levels of cytokines and/or chemokines. In some embodiments, the level of IL-1 beta, IL-2, IL-4, IL-6, IL-8, IL- 10, IL-12p40, IL- 17 A, TNFa, and/or IFNy is analyzed.

[180] In some embodiments, provided herein is a method of treating psoriasis comprising administering (e.g., orally administering) to a human subject a strain of a Prevotella histicola and/or a composition (e.g., a pharmaceutical composition and/or a solid dosage form) comprising a strain of Prevotella histicola provided herein. In some embodiments, the human subject has a confirmed diagnosis of mild to moderate plaque-type psoriasis for at least 6 months involving no more than 10% of body surface area (BSA) (excluding the scalp). In some embodiments, the human subject has a minimum of 2 psoriatic lesions. In some embodiments, the subject has not received systemic non-biologic psoriasis therapy (methotrexate [MTX], steroids, cyclophosphamide) or psoralen plus ultraviolet A (PUVA)/ultraviolet A (UVA) phototherapy within 4 weeks prior to dosing. In some embodiments, subject has not received treatment with biologic agents within 12 months prior to first dose. In some embodiments, the subject is not continuing use of topical or oral pharmacologically active agents 2 weeks prior to the start of dosing. In some embodiments, the human subject has a documented diagnosis of plaque psoriasis for >6 months. In some embodiments, the psoriasis comprises mild psoriasis. In some embodiments, the psoriasis comprises moderate psoriasis. In some embodiments, the psoriasis comprises severe psoriasis.

[181] In some embodiments, the human subject has had mild to moderate plaque psoriasis with plaque covering BSA of >3% and <10% and meet both of the following additional criteria: (i) PASI score of >6 and <15, and (ii) PGA score of 2 or 3.

[182] In some embodiments, the method decreases the PASI (Psoriasis Area and Severity Index) score in the subject, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s PASI score prior to the commencement of treatment).

[183] In some embodiments, the method increases a PASI percentage response rate (e.g., PASI-50, PASI-75, PASI-90, or PASI-100), e.g., as described herein. For example, the percentage of subjects who achieve a 75% or greater reduction in PASI score from baseline is represented by the PASI-75 value, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment.

[184] In some embodiments, the method decreases the LSS (Lesion Severity Score) in the subject, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s LSS prior to the commencement of treatment), e.g., as described herein.

[185] In some embodiments, the method decreases the PGA (Physician’s Global Assessment) score in the subject, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s PGA score prior to the commencement of treatment), e.g., as described herein.

[186] In some embodiments, the method decreases the percent of BSA (Body Surface Area) involvement in the subject, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s percent involvement prior to the commencement of treatment), e.g., as described herein.

[187] In some embodiments, the method decreases the mNAPSI (Modified Nail Psoriasis Severity Index) score in the subject, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s mNAPSI score prior to the commencement of treatment), e.g., as described herein.

[188] In some embodiments, the method improves (e.g., decreases) the DLQI (Dermatology Life Quality Index) score in the subject, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s DLQI score prior to the commencement of treatment), e.g., as described herein.

[189] In some embodiments, the method improves the product of PGA and BSA in the subject, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s product of PGA and BSA prior to the commencement of treatment), e.g., as described herein.

[190] In some embodiments, the method improves (e.g., decreases) the PSI (Psoriasis Symptom Inventory) score in the subject, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s PSI score prior to the commencement of treatment), e.g., as described herein.

[191] In some embodiments, the method decreases pain in the subject, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s pain prior to the commencement of treatment), e.g., as described herein. For example, pain can be assessed by the SF-36 Bodily Pain Scale (SF-36 BPS) or the VAS Pain.

[192] In some embodiments, the method decreases fatigue in the subject, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s fatigue prior to the commencement of treatment), e.g., as described herein.

[193] In some embodiments, provided herein are methods of treating a subject who has atopic dermatitis (e.g., mild to moderate atopic dermatitits, or mild, moderate, or severe atopic dermatitis) comprising administering to the subject a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein.

[194] In some embodiments, provided herein is a method of treating atopic dermatitis comprising administering (e.g., orally administering) to a human subject a strain of a Prevotella histicola and/or a composition (e.g., a pharmaceutical composition and/or a solid dosage form) comprising a strain of Prevotella histicola. In some embodiments, the human subject has a confirmed diagnosis of mild to moderate atopic dermatitis for at least 6 months involving a minimum of 3% to a maximum of 15% body surface area. In some embodiments, the subject has had a confirmed diagnosis of mild to moderate atopic dermatitis with an IGA score of 2 or 3. In some embodiments, the human subject has moderate atopic dermatitis with a minimum of 5% and a maximum of 40% BSA involvement, and an IGA score of 2 or 3. In some embodiments, the human subject has severe atopic dermatitis. In some embodiments, the subject has at least 2 atopic dermatitis lesions with at least 1 in a site suitable for biopsy. In some embodiments, the subject is not receiving systemic non-biologic atopic dermatitis therapy (methotrexate (MTX), steroids, cyclophosphamide, or has received therapy within 4 weeks prior to dosing. In some embodiments, wherein the human subject is not receiving treatment with biologic agents within 12 months prior to first dose. In some embodiments, wherein the human subject is not continuing to use topical or oral pharmacologically active agents 2 weeks prior to the start of dosing. In some embodiments, the atopic dermatitis comprises mild atopic dermatitis. In some embodiments, the atopic dermatitis comprises moderate atopic dermatitis. In some embodiments, the atopic dermatitis comprises mild to moderate atopic dermatitis.

[195] In some embodiments, the method decreases the EASI (Eczema Area and Severity Index) score in the subject, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s EASI score prior to the commencement of treatment), e.g., as described herein. For example, the percentage of subjects achieving EASI-50; EASI-75; or EASI-90.

[196] In some embodiments, the method decreases the SCORAD (SCORing Atopic Dermatitis) score in the subject, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s SCORAD score prior to the commencement of treatment), e.g., as described herein. For example, the percentage of subjects achieving SCORAD-50 or SCORAD-75.

[197] In some embodiments, the method decreases the IGA (Investigator’s Global Assessment) (v-IGA) score in the subject, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s IGA score prior to the commencement of treatment), e.g., as described herein. For example, the percentage of subjects achieving an IGA score or 0 or 1.

[198] In some embodiments, the method decreases the Percentage of Body Surface Area (BSA) affected by disease in the subject, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s BSA percentage prior to the commencement of treatment), e.g., as described herein. For example, the percentage of subjects achieving BSA-50 or BSA-75; or the percentage of subjects achieving BSA reduction to 3% BSA or less.

[199] In some embodiments, the method improves the product of IGA and BSA in the subject, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s IGA x BSA prior to the commencement of treatment), e.g., as described herein.

[200] In some embodiments, the method improves the Dermatology Life Quality Index (DLQI) score in the subject, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s DLQI score prior to the commencement of treatment), e.g., as described herein.

[201] In some embodiments, the method improves the Patient-Oriented Eczema Measure (POEM) score in the subject, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s POEM score prior to the commencement of treatment), e.g., as described herein.

[202] In some embodiments, the method improves the Pruritus Numerical Rating Scale (Pruritus NRS (e.g., Peak Pruritus Numerical Rating Scale (PP-NRS))) score in the subject, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s Pruritus NRS score prior to the commencement of treatment), e.g., as described herein.

[203] In some embodiments, the method improves the number of courses or days of rescue therapy in the subject, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s SD-NRS score prior to the commencement of treatment), e.g., as described herein.

[204] In some embodiments, the method improves the Sleep Disturbance Numerical Rating Scale (SD-NRS) score in the subject, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s number of courses or days of rescue therapy) prior to the commencement of treatment), e.g., as described herein.

[205] In some embodiments, the method improves an AD rating scale score in the subject, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s AD rating scale score prior to the commencement of treatment), e.g., as described herein. In some embodiments, the AD rating scale score comprises IGA, (e.g., vIGA), EASI, BSA, IGAxBSA, and/or SCORAD.

[206] In some embodiments, the method improves patient reported clinical rating scale score in the subject, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s patient reported clinical rating scale score prior to the commencement of treatment), e.g., as described herein. In some embodiments, the patient reported clinical rating scale score comprises POEM, DLQI, ADCT, PP-NRS and/or SD-NRS.

[207] In some embodiments, the method improves the blood eosinophils in the subject, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s blood eosinophils prior to the commencement of treatment), e.g., as described herein.

[208] In some embodiments, the method improves the Sleep Disturbance Numerical Rating Scale (SD-NRS) score in the subject, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s number of courses or days of rescue therapy) prior to the commencement of treatment), e.g., as described herein.

[209] In some embodiments, the method decreases IgE levels in the subject, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s IgE levels prior to the commencement of treatment), e.g., as described herein.

[210] In some embodiments, the strain of a Prevotella histicola and/or a composition (e.g., a bacterial composition (e.g., pharmaceutical composition) and/or a solid dosage form) comprising a strain of a Prevotella histicola provided herein is administered with an additional therapy, wherein the additional therapy comprises an emollient. In some embodiments, the emollient is a bland additive-free, sodium lauryl sulfate (SLS)-free, and fragrance-free emollient cream, gel, or ointment. In some embodiments, the emollient is used at least daily. In some embodiments, the emollient is used at least twice daily.

[211] In some embodiments, provided herein are methods of treating a subject who has psoriatic arthritis (e.g., mild to moderate psoriatic arthritis, or mild, moderate, or severe psoriatic arthritis) comprising administering to the subject a bacterial composition described herein.

[212] In some embodiments, provided herein is a method of treating psoriatic arthritis comprising administering (e.g., orally administering) to a human subject (e.g., a subject with psoriatic arthritis) a strain of a Prevotella histicola and/or a composition (e.g., a bacterial composition (e.g., pharmaceutical composition) and/or a solid dosage form) comprising a strain of a Prevotella histicola provided herein. In some embodiments, the psoriatic arthritis comprises mild psoriatic arthritis. In some embodiments, the psoriatic arthritis comprises moderate psoriatic arthritis. In some embodiments, the psoriatic arthritis comprises severe psoriatic arthritis.

[213] In some embodiments, the method improves (e.g., increases) the percentage of subjects with an ACR20 response, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the percentage prior to the commencement of treatment), e.g., as described herein.

[214] In some embodiments, the method improves (e.g., increases) the percentage of subjects with an ACR50 response, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the percentage prior to the commencement of treatment), e.g., as described herein. [215] In some embodiments, the method improves (e.g., increases) the percentage of subjects with an ACR70 response, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the percentage prior to the commencement of treatment), e.g., as described herein.

[216] In some embodiments, the method improves (e.g., increases) the Modified Psoriatic Arthritis Response Criteria (PsARC) score in the subject, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s PsARC prior to the commencement of treatment), e.g., as described herein.

[217] In some embodiments, the method decreases the dactylitis severity score in the subject, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s dactylitis severity score prior to the commencement of treatment), e.g., as described herein.

[218] In some embodiments, the method decreases the Clinical Disease Activity Index (CD Al) score in the subject, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s CD Al prior to the commencement of treatment), e.g., as described herein.

[219] In some embodiments, the method decreases the DAS28 score in the subject, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s DAS28 prior to the commencement of treatment), e.g., as described herein.

[220] In some embodiments, the method decreases the Maastricht Ankylosing Spondylitis Enthesis Score (MASES) in the subject, e.g., after 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s MASES prior to the commencement of treatment), e.g., as described herein.

[221] In some aspects, the disclosure provides a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein (e.g., in an amount described herein) for use in treating psoriasis (e.g., mild to moderate psoriasis, or mild, moderate, or severe psoriasis).

[222] In some aspects, the disclosure provides a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein (e.g., in an amount described herein) for use in treating atopic dermatitis (e.g., mild to moderate atopic dermatitits, or mild, moderate, or severe atopic dermatitis).

[223] In some aspects, the disclosure provides a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein (e.g., in an amount described herein) for use in treating psoriatic arthritis (e.g., mild to moderate psoriatic arthritis, or mild, moderate, or severe psoriatic arthritis).

[224] In some aspects, the disclosure provides use of a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein (e.g., in an amount described herein) for the preparation of a medicament for the treatment of psoriasis (e.g., mild to moderate psoriasis, or mild, moderate, or severe psoriasis).

[225] In some aspects, the disclosure provides use of a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein (e.g., in an amount described herein) for the preparation of a medicament for the treatment of atopic dermatitis (e.g., mild to moderate atopic dermatitits, or mild, moderate, or severe atopic dermatitis).

[226] In some aspects, the disclosure provides use of a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein (e.g., in an amount described herein) for the preparation of a medicament for the treatment of psoriatic arthritis (e.g., mild to moderate psoriatic arthritis, or mild, moderate, or severe psoriatic arthritis).

[227] In some aspects, the disclosure provides a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein (e.g., in an amount described herein) for use in treating an inflammatory disease. In some embodiments, the inflammatory disease is a Thl, Th2, or Thl7 inflammatory disease.

[228] In some aspects, the disclosure provides a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein (e.g., in an amount described herein) for use in treating an immune disorder.

[229] In some aspects, the disclosure provides use of a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein (e.g., in an amount described herein) for the preparation of a medicament for the treatment of an inflammatory disease. In some embodiments, the inflammatory disease is a Thl, Th2, or Thl7 inflammatory disease.

[230] In some aspects, the disclosure provides use of a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein (e.g., in an amount described herein) for the preparation of a medicament for the treatment of an immune disorder.

[231] In some aspects, the disclosure provides use of a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein (e.g., in an amount described herein) for the preparation of a medicament for the treatment of an autoimmune disease, (e.g., in a subject, e.g., a human subject) and methods of using such bacterial compositions (e.g., for the treatment of an autoimmune disease).

[232] In some aspects, the disclosure provides a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein (e.g., in an amount described herein) for use in treating an autoimmune disease.

[233] In some aspects, the disclosure provides use of a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein (e.g., in an amount described herein) for the preparation of a medicament for the treatment of an inflammatory disease, (e.g., in a subject, e.g., a human subject) and methods of using such bacterial compositions (e.g., for the treatment of an inflammatory disease).

[234] In some aspects, the disclosure provides a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein (e.g., in an amount described herein) for use in treating an inflammatory disease.

[235] In some aspects, the disclosure provides use of a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein (e.g., in an amount described herein) for the preparation of a medicament for the treatment of a metabolic disease, (e.g., in a subject, e.g., a human subject) and methods of using such bacterial compositions (e.g., for the treatment of a metabolic disease).

[236] In some aspects, the disclosure provides a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein (e.g., in an amount described herein) for use in treating a metabolic disease.

[237] In some aspects, the disclosure provides use of a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein (e.g., in an amount described herein) for the preparation of a medicament for the treatment of a dysbiosis, (e.g., in a subject, e.g., a human subject) and methods of using such bacterial compositions (e.g., for the treatment of a dysbiosis).

[238] In some aspects, the disclosure provides a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein (e.g., in an amount described herein) for use in treating a dysbiosis.

[239] In some aspects, the disclosure provides use of a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein (e.g., in an amount described herein) for the preparation of a medicament for decreasing inflammatory cytokine expression (e.g., decreased IL-8, IL-6, IL-ip, and/or TNFa expression levels), (e.g., in a subject, e.g., a human subject) and methods of using such bacterial compositions (e.g., for decreasing inflammatory cytokine expression (e.g., decreased IL-8, IL-6, IL-ip, and/or TNFa expression levels)).

[240] In some aspects, the disclosure provides a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein (e.g., in an amount described herein) for use in decreasing inflammatory cytokine expression (e.g., decreased IL-8, IL-6, IL-ip, and/or TNFa expression levels).

[241] In some aspects, the disclosure provides use of a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein (e.g., in an amount described herein) for the preparation of a medicament for decreasing IgE levels (e.g., in a subject, e.g., a human subject) and methods of using such bacterial compositions (e.g., for decreasing IgE levels).

[242] In some aspects, the disclosure provides a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein (e.g., in an amount described herein) for use in decreasing IgE levels.

[243] In some aspects, the disclosure provides use of a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein (e.g., in an amount described herein) for the preparation of a medicament for decreasing IL-31, IL-23p40, IL- 17, IL-4, IL-5, and/or IL- 13 levels (e.g., in a subject, e.g., a human subject) and methods of using such bacterial compositions (e.g., for decreasing inflammatory cytokine expression (e.g., decreased IL-31, IL-23p40, IL-17, IL-4, IL-5, and/or IL-13 levels)).

[244] In some aspects, the disclosure provides a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein (e.g., in an amount described herein) for use in decreasing IL-31, IL-23p40, IL-17, IL-4, IL-5, and/or IL-13 levels.

[245] In some aspects, the disclosure provides use of a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein (e.g., in an amount described herein) for the preparation of a medicament for the treatment of bacterial septic shock, cytokine storm and/or viral infection, (e.g., in a subject, e.g., a human subject) and methods of using such bacterial compositions (e.g., for the treatment of bacterial septic shock, cytokine storm and/or viral infection).

[246] In some aspects, the disclosure provides a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein (e.g., in an amount described herein) for use in treating bacterial septic shock, cytokine storm and/or viral infection. [247] In some aspects, the disclosure provides use of a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein (e.g., in an amount described herein) for the preparation of a medicament for the treatment of a viral infection, (e.g., in a subject, e.g., a human subject) and methods of using such bacterial compositions (e.g., for the treatment of a viral infection). In some embodiments, the viral infection is a coronavirus infection, an influenza infection, and/or a respiratory syncytial virus infection. In some embodiments the viral infection is a SARS-CoV-2 infection.

[248] In some aspects, the disclosure provides a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein (e.g., in an amount described herein) for use in treating a viral infection. In some embodiments, the viral infection is a coronavirus infection, an influenza infection, and/or a respiratory syncytial virus infection. In some embodiments the viral infection is a SARS-CoV-2 infection.

[249] In some embodiments, provided herein are methods of decreasing inflammation in a subject (e.g., a subject who has psoriasis (e.g., mild to moderate psoriasis, or mild, moderate, or severe psoriasis) and/or atopic dermatitis (e.g., mild to moderate atopic dermatitis, or mild, moderate, or severe atopic dermatitis)) and/or psoriatic arthritis (e.g., mild, moderate, or severe psoriatic arthritis) comprising administering to the subject a bacterial composition (e.g., a bacterial composition and/or a solid dosage form) described herein, wherein the effects on inflammation of the administration of the bacterial composition persist for at least 24 weeks after last dosing the subject (e.g., the level of inflammation is lower 24 weeks after last dosing the subject, as compared to the level of inflammation prior to commencement of dosing the subject ). Persistence can be determined by the decrease in the level of inflammation being greater at 24 weeks after last dosing the subject than the level of inflammation prior to commencement of dosing the subject.

[250] In some aspects, the disclosure provides a method of treating psoriasis (e.g., mild to moderate psoriasis, or mild, moderate, or severe psoriasis) in a human subject comprising orally administering (e.g., once or twice daily) to the human subject a dose of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the dose is formulated in one solid dosage form (e.g., tablet or capsule) and comprises about 3.2 x 10¹¹ total cells of the bacteria. In some embodiments, the dose is administered for at least 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. In some embodiments, the solid dosage form (also referred to as a solid dose form) is a capsule. In some embodiments, the solid dosage form is enteric coated. In some embodiments, the enteric coating is at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dose form (e.g., per capsule (e.g., between about 5 mg to about 31 mg per size 0 capsule)). In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² (e.g., about 5 mg per size 0 capsule); about 1.7 mg/cm² (e.g., about 9 mg per size 0 capsule); about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule); about 3.7 mg/cm² (e.g., about 19 mg per size 0 capsule); about 4.8 mg/cm² (e.g., about 25 mg per size 0 capsule); or about 6 mg/cm² (e.g., about 31 mg per size 0 capsule) per solid dose form (such as a capsule).

[251] In some aspects, the disclosure provides a method of treating psoriasis (e.g., mild to moderate psoriasis, or mild, moderate, or severe psoriasis) in a human subject comprising orally administering (e.g., once or twice daily) to the human subject a dose of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the dose is formulated in two solid dosage forms (e.g., tablets or capsules) and each solid dosage form comprises about 3.2 x 10¹¹ total cells of the bacteria. In some embodiments, the dose is administered for at least 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. In some embodiments, the solid dosage form (also referred to as a solid dose form) is a capsule. In some embodiments, the solid dosage form is enteric coated. In some embodiments, the enteric coating is at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dose form (e.g., per capsule (e.g., between about 5 mg to about 31 mg per size 0 capsule)). In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² (e.g., about 5 mg per size 0 capsule); about 1.7 mg/cm² (e.g., about 9 mg per size 0 capsule); about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule); about 3.7 mg/cm² (e.g., about 19 mg per size 0 capsule); about 4.8 mg/cm² (e.g., about 25 mg per size 0 capsule); or about 6 mg/cm² (e.g., about 31 mg per size 0 capsule) per solid dose form (such as a capsule).

[252] In some aspects, the disclosure provides a method of treating psoriasis (e.g., mild to moderate psoriasis, or mild, moderate, or severe psoriasis) in a human subject comprising orally administering (e.g., once or twice daily) to the human subject a dose of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the dose is formulated in one solid dosage form (e.g., tablet or capsule) and comprises about 8 x 10¹⁰ total cells of the bacteria. In some embodiments, the dose is administered for at least 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. In some embodiments, the solid dosage form (also referred to as a solid dose form) is a capsule. In some embodiments, the solid dosage form is enteric coated. In some embodiments, the enteric coating is at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dose form (e.g., per capsule (e.g., between about 5 mg to about 31 mg per size 0 capsule)). In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² (e.g., about 5 mg per size 0 capsule); about 1.7 mg/cm² (e.g., about 9 mg per size 0 capsule); about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule); about 3.7 mg/cm² (e.g., about 19 mg per size 0 capsule); about 4.8 mg/cm² (e.g., about 25 mg per size 0 capsule); or about 6 mg/cm² (e.g., about 31 mg per size 0 capsule) per solid dose form (such as a capsule).

[253] In some aspects, the disclosure provides a method of treating psoriasis (e.g., mild to moderate psoriasis, or mild, moderate, or severe psoriasis) in a human subject comprising orally administering (e.g., once or twice daily) to the human subject a dose of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the dose is formulated in two solid dosage forms (e.g., tablets or capsules) and each solid dosage form comprises about 8 x IO¹⁰ total cells of the bacteria. In some embodiments, the dose is administered for at least 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. In some embodiments, the solid dosage form (also referred to as a solid dose form) is a capsule. In some embodiments, the solid dosage form is enteric coated. In some embodiments, the enteric coating is at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dose form (e.g., per capsule (e.g., between about 5 mg to about 31 mg per size 0 capsule)). In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² (e.g., about 5 mg per size 0 capsule); about 1.7 mg/cm² (e.g., about 9 mg per size 0 capsule); about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule); about 3.7 mg/cm² (e.g., about 19 mg per size 0 capsule); about 4.8 mg/cm² (e.g., about 25 mg per size 0 capsule); or about 6 mg/cm² (e.g., about 31 mg per size 0 capsule) per solid dose form (such as a capsule).

[254] In some aspects, the disclosure provides a method of treating atopic dermatitis (e.g., mild to moderate atopic dermatitis, or mild, moderate, or severe atopic dermatitis) in a human subject comprising orally administering (e.g., once or twice daily) to the human subject a dose of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the dose is formulated in one solid dosage form (e.g., tablet or capsule) and comprises about 3.2 x 10¹¹ total cells of the bacteria. In some embodiments, the dose is administered for at least 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. In some embodiments, the solid dosage form (also referred to as a solid dose form) is a capsule. In some embodiments, the solid dosage form is enteric coated. In some embodiments, the enteric coating is at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dose form (e.g., per capsule (e.g., between about 5 mg to about 31 mg per size 0 capsule)). In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² (e.g., about 5 mg per size 0 capsule); about 1.7 mg/cm² (e.g., about 9 mg per size 0 capsule); about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule); about 3.7 mg/cm² (e.g., about 19 mg per size 0 capsule); about 4.8 mg/cm² (e.g., about 25 mg per size 0 capsule); or about 6 mg/cm² (e.g., about 31 mg per size 0 capsule) per solid dose form (such as a capsule).

[255] In some aspects, the disclosure provides a method of treating atopic dermatitis (e.g., mild to moderate atopic dermatitis, or mild, moderate, or severe atopic dermatitis) in a human subject comprising orally administering (e.g., once or twice daily) to the human subject a dose of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the dose is formulated in two solid dosage forms (e.g., tablets or capsules) and each solid dosage form comprises about 3.2 x 10¹¹ total cells of the bacteria. In some embodiments, the dose is administered for at least 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. In some embodiments, the solid dosage form (also referred to as a solid dose form) is a capsule. In some embodiments, the solid dosage form is enteric coated. In some embodiments, the enteric coating is at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dose form (e.g., per capsule (e.g., between about 5 mg to about 31 mg per size 0 capsule)). In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² (e.g., about 5 mg per size 0 capsule); about 1.7 mg/cm² (e.g., about 9 mg per size 0 capsule); about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule); about 3.7 mg/cm² (e.g., about 19 mg per size 0 capsule); about 4.8 mg/cm² (e.g., about 25 mg per size 0 capsule); or about 6 mg/cm² (e.g., about 31 mg per size 0 capsule) per solid dose form (such as a capsule).

[256] In some aspects, the disclosure provides a method of treating atopic dermatitis (e.g., mild to moderate atopic dermatitis, or mild, moderate, or severe atopic dermatitis) in a human subject comprising orally administering (e.g., once or twice daily) to the human subject a dose of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the dose is formulated in one solid dosage form (e.g., tablet or capsule) and comprises about 8 x 10¹⁰ total cells of the bacteria. In some embodiments, the dose is administered for at least 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. In some embodiments, the solid dosage form (also referred to as a solid dose form) is a capsule. In some embodiments, the solid dosage form is enteric coated. In some embodiments, the enteric coating is at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dose form (e.g., per capsule (e.g., between about 5 mg to about 31 mg per size 0 capsule)). In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² (e.g., about 5 mg per size 0 capsule); about 1.7 mg/cm² (e.g., about 9 mg per size 0 capsule); about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule); about 3.7 mg/cm² (e.g., about 19 mg per size 0 capsule); about 4.8 mg/cm² (e.g., about 25 mg per size 0 capsule); or about 6 mg/cm² (e.g., about 31 mg per size 0 capsule) per solid dose form (such as a capsule).

[257] In some aspects, the disclosure provides a method of treating atopic dermatitis (e.g., mild to moderate atopic dermatitis, or mild, moderate, or severe atopic dermatitis) in a human subject comprising orally administering (e.g., once or twice daily) to the human subject a dose of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the dose is formulated in two solid dosage forms (e.g., tablets or capsules) and each solid dosage form comprises about 8 x IO¹⁰ total cells of the bacteria. In some embodiments, the dose is administered for at least 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. In some embodiments, the solid dosage form (also referred to as a solid dose form) is a capsule. In some embodiments, the solid dosage form is enteric coated. In some embodiments, the enteric coating is at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dose form (e.g., per capsule (e.g., between about 5 mg to about 31 mg per size 0 capsule)). In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² (e.g., about 5 mg per size 0 capsule); about 1.7 mg/cm² (e.g., about 9 mg per size 0 capsule); about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule); about 3.7 mg/cm² (e.g., about 19 mg per size 0 capsule); about 4.8 mg/cm² (e.g., about 25 mg per size 0 capsule); or about 6 mg/cm² (e.g., about 31 mg per size 0 capsule) per solid dose form (such as a capsule).

[258] In some aspects, the disclosure provides a method of treating psoriatic arthritis (e.g., mild to moderate psoriatic arthritis, or mild, moderate, or severe psoriatic arthritis) in a human subject comprising orally administering (e.g., once or twice daily) to the human subject a dose of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the dose is formulated in one solid dosage form (e.g., tablet or capsule) and comprises about 3.2 x 10¹¹ total cells of the bacteria. In some embodiments, the dose is administered for at least 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. In some embodiments, the solid dosage form (also referred to as a solid dose form) is a capsule. In some embodiments, the solid dosage form is enteric coated. In some embodiments, the enteric coating is at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dose form (e.g., per capsule (e.g., between about 5 mg to about 31 mg per size 0 capsule)). In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² (e.g., about 5 mg per size 0 capsule); about 1.7 mg/cm² (e.g., about 9 mg per size 0 capsule); about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule); about 3.7 mg/cm² (e.g., about 19 mg per size 0 capsule); about 4.8 mg/cm² (e.g., about 25 mg per size 0 capsule); or about 6 mg/cm² (e.g., about 31 mg per size 0 capsule) per solid dose form (such as a capsule).

[259] In some aspects, the disclosure provides a method of treating psoriatic arthritis (e.g., mild to moderate psoriatic arthritis, or mild, moderate, or severe psoriatic arthritis) in a human subject comprising orally administering (e.g., once or twice daily) to the human subject a dose of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the dose is formulated in two solid dosage forms (e.g., tablets or capsules) and each solid dosage form comprises about 3.2 x 10¹¹ total cells of the bacteria. In some embodiments, the dose is administered for at least 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. In some embodiments, the solid dosage form (also referred to as a solid dose form) is a capsule. In some embodiments, the solid dosage form is enteric coated. In some embodiments, the enteric coating is at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dose form (e.g., per capsule (e.g., between about 5 mg to about 31 mg per size 0 capsule)). In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² (e.g., about 5 mg per size 0 capsule); about 1.7 mg/cm² (e.g., about 9 mg per size 0 capsule); about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule); about 3.7 mg/cm² (e.g., about 19 mg per size 0 capsule); about 4.8 mg/cm² (e.g., about 25 mg per size 0 capsule); or about 6 mg/cm² (e.g., about 31 mg per size 0 capsule) per solid dose form (such as a capsule).

[260] In some aspects, the disclosure provides a method of treating psoriatic arthritis (e.g., mild to moderate psoriatic arthritis, or mild, moderate, or severe psoriatic arthritis) in a human subject comprising orally administering (e.g., once or twice daily) to the human subject a dose of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the dose is formulated in one solid dosage form (e.g., tablet or capsule) and comprises about 8 x 10¹⁰ total cells of the bacteria. In some embodiments, the dose is administered for at least 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. In some embodiments, the solid dosage form (also referred to as a solid dose form) is a capsule. In some embodiments, the solid dosage form is enteric coated. In some embodiments, the enteric coating is at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dose form (e.g., per capsule (e.g., between about 5 mg to about 31 mg per size 0 capsule)). In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² (e.g., about 5 mg per size 0 capsule); about 1.7 mg/cm² (e.g., about 9 mg per size 0 capsule); about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule); about 3.7 mg/cm² (e.g., about 19 mg per size 0 capsule); about 4.8 mg/cm² (e.g., about 25 mg per size 0 capsule); or about 6 mg/cm² (e.g., about 31 mg per size 0 capsule) per solid dose form (such as a capsule).

[261] In some aspects, the disclosure provides a method of treating psoriatic arthritis (e.g., mild to moderate psoriatic arthritis, or mild, moderate, or severe psoriatic arthritis) in a human subject comprising orally administering (e.g., once or twice daily) to the human subject a dose of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the dose is formulated in two solid dosage forms (e.g., tablets or capsules) and each solid dosage form comprises about 8 x IO¹⁰ total cells of the bacteria. In some embodiments, the dose is administered for at least 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. In some embodiments, the solid dosage form (also referred to as a solid dose form) is a capsule. In some embodiments, the solid dosage form is enteric coated. In some embodiments, the enteric coating is at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dose form (e.g., per capsule (e.g., between about 5 mg to about 31 mg per size 0 capsule)). In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² (e.g., about 5 mg per size 0 capsule); about 1.7 mg/cm² (e.g., about 9 mg per size 0 capsule); about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule); about 3.7 mg/cm² (e.g., about 19 mg per size 0 capsule); about 4.8 mg/cm² (e.g., about 25 mg per size 0 capsule); or about 6 mg/cm² (e.g., about 31 mg per size 0 capsule) per solid dose form (such as a capsule).

[262] In some aspects, the disclosure provides a method of reducing inflammation in a human subject comprising orally administering (e.g., once or twice daily) to the human subject a dose of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the dose is formulated in one solid dosage form (e.g., tablet or capsule) and comprises about 3.2 x 10¹¹ total cells of the bacteria. In some embodiments, the dose is administered for at least 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. In some embodiments, the solid dosage form (also referred to as a solid dose form) is a capsule. In some embodiments, the In some embodiments, the solid dosage form is enteric coated. In some embodiments, the enteric coating is at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dose form (e.g., per capsule (e.g., between about 5 mg to about 31 mg per size 0 capsule)). In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² (e.g., about 5 mg per size 0 capsule); about 1.7 mg/cm² (e.g., about 9 mg per size 0 capsule); about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule); about 3.7 mg/cm² (e.g., about 19 mg per size 0 capsule); about 4.8 mg/cm² (e.g., about 25 mg per size 0 capsule); or about 6 mg/cm² (e.g., about 31 mg per size 0 capsule) per solid dose form (such as a capsule).

[263] In some aspects, the disclosure provides a method of reducing inflammation in a human subject comprising orally administering (e.g., once or twice daily) to the human subject a dose of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the dose is formulated in two solid dosage forms (e.g., tablets or capsules) and each solid dosage form comprises about 3.2 x 10¹¹ total cells of the bacteria. In some embodiments, the dose is administered for at least 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. In some embodiments, the solid dosage form (also referred to as a solid dose form) is a capsule. In some embodiments, the solid dosage form is enteric coated. In some embodiments, the enteric coating is at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dose form (e.g., per capsule (e.g., between about 5 mg to about 31 mg per size 0 capsule)). In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² (e.g., about 5 mg per size 0 capsule); about 1.7 mg/cm² (e.g., about 9 mg per size 0 capsule); about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule); about 3.7 mg/cm² (e.g., about 19 mg per size 0 capsule); about 4.8 mg/cm² (e.g., about 25 mg per size 0 capsule); or about 6 mg/cm² (e.g., about 31 mg per size 0 capsule) per solid dose form (such as a capsule).

[264] In some aspects, the disclosure provides a method of reducing inflammation in a human subject comprising orally administering (e.g., once or twice daily) to the human subject a dose of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the dose is formulated in one solid dosage form (e.g., tablet or capsule) and comprises about 8 x 10¹⁰ total cells of the bacteria. In some embodiments, the dose is administered for at least 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. In some embodiments, the solid dosage form (also referred to as a solid dose form) is a capsule. In some embodiments, the solid dosage form is enteric coated. In some embodiments, the enteric coating is at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dose form (e.g., per capsule (e.g., between about 5 mg to about 31 mg per size 0 capsule)). In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² (e.g., about 5 mg per size 0 capsule); about 1.7 mg/cm² (e.g., about 9 mg per size 0 capsule); about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule); about 3.7 mg/cm² (e.g., about 19 mg per size 0 capsule); about 4.8 mg/cm² (e.g., about 25 mg per size 0 capsule); or about 6 mg/cm² (e.g., about 31 mg per size 0 capsule) per solid dose form (such as a capsule).

[265] In some aspects, the disclosure provides a method of reducing inflammation in a human subject comprising orally administering (e.g., once or twice daily) to the human subject a dose of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the dose is formulated in two solid dosage forms (e.g., tablets or capsules) and each solid dosage form comprises about 8 x IO¹⁰ total cells of the bacteria. In some embodiments, the dose is administered for at least 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. In some embodiments, the solid dosage form (also referred to as a solid dose form) is a capsule. In some embodiments, the solid dosage form is enteric coated. In some embodiments, the enteric coating is at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dose form (e.g., per capsule (e.g., between about 5 mg to about 31 mg per size 0 capsule)). In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² (e.g., about 5 mg per size 0 capsule); about 1.7 mg/cm² (e.g., about 9 mg per size 0 capsule); about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule); about 3.7 mg/cm² (e.g., about 19 mg per size 0 capsule); about 4.8 mg/cm² (e.g., about 25 mg per size 0 capsule); or about 6 mg/cm² (e.g., about 31 mg per size 0 capsule) per solid dose form (such as a capsule).

[266] In some embodiments, the inflammation comprises Thl inflammation.

[267] In some embodiments, the inflammation comprises Th2 inflammation.

[268] In some embodiments, the inflammation comprises Th 17 inflammation.

DETAILED DESCRIPTION

[269] Prevotella histicola is a natural human commensal organism, commonly found on oral, nasopharyngeal, gastrointestinal (GI), and genito-urinary mucosal surfaces. Preclinical studies using Prevotella histicola Strain B have been carried out across a range of human and mouse primary cell in vitro assays, which support the use of this agent in the treatment of psoriasis, atopic dermatitis, and psoriatic arthritis. As described herein, Prevotella histicola Strain B can be used for at least 8 weeks.

[270] In some aspects, described herein is an oral therapy for treating an inflammatory disease with Prevotella histicola Strain B. In some embodiments, the inflammatory disease is a Thl, Th2, or Thl7 inflammatory disease. In some aspects, described herein is an oral therapy for treating an immune disorder with Prevotella histicola Strain B.

[271] In some aspects, described herein is an oral therapy for treating psoriasis with Prevotella histicola Strain B.

[272] In some aspects, described herein is an oral therapy for treating atopic dermatitis with Prevotella histicola Strain B.

[273] In some aspects, described herein is an oral therapy for treating psoriatic arthritis with Prevotella histicola Strain B.

[274] In some aspects, described herein is an oral therapy for treating an autoimmune disease with Prevotella histicola Strain B.

[275] In some aspects, described herein is an oral therapy for treating a metabolic disease with Prevotella histicola Strain B.

[276] In some aspects, described herein is an oral therapy for treating a dysbiosis with Prevotella histicola Strain B.

[277] In some aspects, described herein is an oral therapy for decreasing inflammatory cytokine expression (e.g., decreased IL-8, IL-6, IL-ip, and/or TNFa expression levels with Prevotella histicola Strain B.

[278] In some aspects, described herein is an oral therapy for decreasing IgE levels with Prevotella histicola Strain B.

[279] In some aspects, described herein is an oral therapy for treating bacterial septic shock with Prevotella histicola Strain B.

[280] In some aspects, described herein is an oral therapy for treating a viral infection with Prevotella histicola Strain B.

[281] In some aspects, described herein is an oral therapy for treating a cytokine storm with Prevotella histicola Strain B.

[282] As demonstrated herein, the coating level (also referred to herein as thickness) of the enteric coating on a solid dosage form influences the site of release of the Prevotella histicola from the solid dosage form after oral administration. For example, a coating level of enteric coating on the solid dosage form is designed to protect the Prevotella histicola from release in the stomach (that is, the enteric coating maintains gastric integrity). After the solid dosage form exits the stomach (that is, after gastric emptying), the coating level of the enteric coat influences the time to release of the Prevotella histicola from the solid dosage form, e.g., the time to release after gastric emptying. For example, a coating level of enteric coating is designed to release the Prevotella histicola from the solid dosage form in the small intestine, such as in the jejunum or the ileum. Release of the Prevotella histicola can be determined by scintigraphy studies, as provided herein. In some embodiments, the solid dosage form releases the Prevotella histicola contained therein in the small intestine. In some embodiments, the solid dosage form releases the Prevotella histicola contained therein beyond the duodenum, for example, downstream of bile duct juncture. In some embodiments, the solid dosage form releases the Prevotella histicola contained therein in the jejunum. In some embodiments, the solid dosage form releases the Prevotella histicola contained therein in the ileum.

Definitions

[283] Unless specifically stated or obvious from context, as used herein, the term "or" is understood to be inclusive (i.e., a composition “comprising elements A, B, or C” would not exclude a composition containing both elements A and B, a composition containing both elements B and C, a composition containing both elements A and C, or a composition containing all of elements A, B, and C). Unless specifically stated or obvious from context, as used herein, the terms “a,” “an,” and “the” are understood to be singular or plural.

[284] The term “about” when used before a numerical value indicates that the value may vary within a reasonable range, such as within ± 10%, ± 5% or ± 1% of the stated value.

[285] “Adjuvant” or “adjuvant therapy” broadly refers to an agent that affects an immunological or physiological response in a patient or subject. For example, an adjuvant might increase the presence of an antigen over time or help absorb an antigen presenting cell antigen, activate macrophages and lymphocytes and support the production of cytokines. By changing an immune response, an adjuvant might permit a smaller dose of an immune interacting agent to increase the effectiveness or safety of a particular dose of the immune interacting agent. For example, an adjuvant might prevent T cell exhaustion and thus increase the effectiveness or safety of a particular immune interacting agent.

[286] “Administration” broadly refers to a route of administration of a composition to a subject. Examples of routes of administration include oral administration, rectal administration, topical administration, inhalation (nasal) or injection. Administration by injection includes intravenous (IV), intramuscular (IM), and subcutaneous (SC) administration. The bacterial compositions described herein can be administered in any form by any effective route, including but not limited to oral, parenteral, enteral, intravenous, intraperitoneal, topical, transdermal (e.g., using any standard patch), intradermal, ophthalmic, (intra)nasally, local, non-oral, such as aerosol, inhalation, subcutaneous, intramuscular, buccal, sublingual, (trans)rectal, vaginal, intra-arterial, and intrathecal, transmucosal (e.g., sublingual, lingual, (trans)buccal, (trans)urethral, vaginal (e.g., trans- and perivaginally), implanted, intravesical, intrapulmonary, intraduodenal, intragastrical, and intrabronchial. In some embodiments, the bacterial compositions described herein are administered orally, rectally, topically, intravesically, by injection into or adjacent to a draining lymph node, intravenously, by inhalation or aerosol, or subcutaneously. In some embodiments, the bacterial compositions described herein are administered orally.

[287] “ Cellular augmentation” broadly refers to the influx of cells or expansion of cells in an environment that are not substantially present in the environment prior to administration of a composition and not present in the composition itself. Cells that augment the environment include immune cells, stromal cells, bacterial and fungal cells.

[288] “ Clade” refers to the OTUs or members of a phylogenetic tree that are downstream of a statistically valid node in a phylogenetic tree. The clade comprises a set of terminal leaves in the phylogenetic tree that is a distinct monophyletic evolutionary unit and that share some extent of sequence similarity. “Operational taxonomic units,” “OTU” (or plural, “OTUs”) refer to a terminal leaf in a phylogenetic tree and is defined by a nucleic acid sequence, e.g., the entire genome, or a specific genetic sequence, and all sequences that share sequence identity to this nucleic acid sequence at the level of species. In some embodiments the specific genetic sequence may be the 16S sequence or a portion of the 16S sequence. In other embodiments, the entire genomes of two entities are sequenced and compared. In another embodiment, select regions such as multilocus sequence tags (MLST), specific genes, or sets of genes may be genetically compared. In 16S embodiments, OTUs that share = 97% average nucleotide identity across the entire 16S or some variable region of the 16S are considered the same OTU (see e.g. Claesson M J, Wang Q, O'Sullivan O, Greene-Diniz R, Cole J R, Ros R P, and O'Toole P W. 2010. Comparison of two next-generation sequencing technologies for resolving highly complex microbiota composition using tandem variable 16S rRNA gene regions. Nucleic Acids Res 38: e200. Konstantinidis K T, Ramette A, and Tiedje J M. 2006. The bacterial species definition in the genomic era. Philos Trans R Soc Lond B Biol Sci 361 : 1929-1940.). In embodiments involving the complete genome, MLSTs, specific genes, or sets of genes OTUs that share = 95% average nucleotide identity are considered the same OTU (see e.g. Achtman M, and Wagner M. 2008. Microbial diversity and the genetic nature of microbial species. Nat. Rev. Microbiol. 6: 431-440. Konstantinidis K T, Ramette A, and Tiedje J M. 2006. The bacterial species definition in the genomic era. Philos Trans R Soc Lond B Biol Sci 361 : 1929-1940.). OTUs are frequently defined by comparing sequences between organisms. Generally, sequences with less than 95% sequence identity are not considered to form part of the same OTU. OTUs may also be characterized by any combination of nucleotide markers or genes, in particular highly conserved genes (e.g., “house-keeping” genes), or a combination thereof. Such characterization employs, e.g., WGS data or a whole genome sequence.

[289] A “combination” of two or more monoclonal microbial strains includes the physical co-existence of the two monoclonal microbial strains, either in the same material or product or in physically connected products, as well as the temporal co-admini strati on or colocalization of the monoclonal microbial strains.

[290] The term “decrease” or “deplete” means a qualitative or quantitative difference between a reference and a value that is less than the reference, such that the difference is, depending on circumstances, at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90% of the reference, or such that the value is 1/100, 1/1000, 1/10,000, 1/100,000, 1/1,000,000 of the reference, or such that the value is undetectable after a treatment when compared to a reference representative of a pre-treatment state. Properties that may be decreased include the number of immune cells, bacterial cells, stromal cells, myeloid derived suppressor cells, fibroblasts, metabolites; the level of a cytokine; or another physical parameter (such as ear thickness (e.g., in a DTH animal model) or tumor size (e.g., in an animal tumor model)).

[291] “Dysbiosis” refers to a state of the microbiota or microbiome of the gut or other body area, including, e.g., mucosal or skin surfaces (or any other microbiome niche) in which the normal diversity and/or function of the host gut microbiome ecological networks “microbiome”) are disrupted. A state of dysbiosis may result in a diseased state, or it may be unhealthy under only certain conditions or only if present for a prolonged period. Dysbiosis may be due to a variety of factors, including, environmental factors, infectious agents, host genotype, host diet and/or stress. A dysbiosis may result in: a change (e.g., increase or decrease) in the prevalence of one or more bacteria types (e.g., anaerobic), species and/or strains, change (e.g., increase or decrease) in diversity of the host microbiome population composition; a change (e.g., increase or reduction) of one or more populations of symbiont organisms resulting in a reduction or loss of one or more beneficial effects; overgrowth of one or more populations of pathogens (e.g., pathogenic bacteria); and/or the presence of, and/or overgrowth of, symbiotic organisms that cause disease only when certain conditions are present.

[292] As used herein, “engineered bacteria” are any bacteria that have been genetically altered from their natural state by human intervention and the progeny of any such bacteria. Engineered bacteria include, for example, the products of targeted genetic modification, the products of random mutagenesis screens and the products of directed evolution.

[293] The term “epitope” means a protein determinant capable of specific binding to an antibody or T cell receptor. Epitopes usually consist of chemically active surface groupings of molecules such as amino acids or sugar side chains. Certain epitopes can be defined by a particular sequence of amino acids to which an antibody is capable of binding.

[294] The term “gene” is used broadly to refer to any nucleic acid associated with a biological function. The term “gene” applies to a specific genomic sequence, as well as to a cDNA or an mRNA encoded by that genomic sequence.

[295] “Identity” as between nucleic acid sequences of two nucleic acid molecules can be determined as a percentage of identity using known computer algorithms such as the “FASTA” program, using for example, the default parameters as in Pearson et al. (1988) Proc. Natl. Acad. Sci. USA 85:2444 (other programs include the GCG program package (Devereux, J., et al., Nucleic Acids Research 12(I):387 (1984)), BLASTP, BLASTN, FASTA Atschul, S. F., et al., J Molec Biol 215:403 (1990); Guide to Huge Computers, Martin J. Bishop, ed., Academic Press, San Diego, 1994, and Carillo et al. (1988) SIAM J Applied Math 48: 1073). For example, the BLAST function of the National Center for Biotechnology Information database can be used to determine identity. Other commercially or publicly available programs include, DNAStar “MegAlign” program (Madison, Wis.) and the University of Wisconsin Genetics Computer Group (UWG) “Gap” program (Madison Wis.)).

[296] As used herein, the term “immune disorder” refers to any disease, disorder or disease symptom caused by an activity of the immune system, including autoimmune diseases, inflammatory diseases and allergies. Immune disorders include, but are not limited to, autoimmune diseases (e.g., Lupus, Scleroderma, hemolytic anemia, vasculitis, type one diabetes, Grave’s disease, rheumatoid arthritis, multiple sclerosis, Goodpasture’s syndrome, pernicious anemia and/or myopathy), inflammatory diseases (e.g., acne vulgaris, asthma, celiac disease, chronic prostatitis, glomerulonephritis, inflammatory bowel disease, pelvic inflammatory disease, reperfusion injury, rheumatoid arthritis, sarcoidosis, transplant rejection, vasculitis and/or interstitial cystitis), and/or an allergies (e.g., food allergies, drug allergies and/or environmental allergies).

[297] “Immunotherapy” is treatment that uses a subject’s immune system to treat disease (e.g., immune disease) and includes, for example, checkpoint inhibitors, cytokines, cell therapy, CAR-T cells, and dendritic cell therapy.

[298] The term “increase” means a qualitative or quantitative difference between a reference and a value that is more than the reference, such that the difference is, depending on circumstances, at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 2-fold, 4- fold, 10-fold, 100-fold, 10^A3 fold, 10^A4 fold, 10^A5 fold, 10^A6 fold, and/or 10^A7 fold of the reference, e.g., where the difference is between a reference representative of a pre-treatment state and a value that is representative of a post-treatment state. Properties that may be increased include the number of immune cells, bacterial cells, stromal cells, myeloid derived suppressor cells, fibroblasts, metabolites; the level of a cytokine; or another physical parameter (such as ear thickness (e.g., in a DTH animal model) or tumor size (e.g., in an animal tumor model).

[299] “Innate immune agonists” or “immuno-adjuvants” are small molecules, proteins, or other agents that specifically target innate immune receptors including Toll-Like Receptors (TLR), NOD receptors, RLRs, C-type lectin receptors, STING-cGAS Pathway components, inflammasome complexes. For example, LPS is a TLR-4 agonist that is bacterially derived or synthesized and aluminum can be used as an immune stimulating adjuvant. Immuno- adjuvants are a specific class of broader adjuvant or adjuvant therapy. Examples of STING agonists include, but are not limited to, 2'3'- cGAMP, 3'3'-cGAMP, c-di-AMP, c-di-GMP, 2'2'-cGAMP, and 2'3'-cGAM(PS)2 (Rp/Sp) (Rp, Sp-isomers of the bis-phosphorothioate analog of 2'3'-cGAMP). Examples of TLR agonists include, but are not limited to, TLR1, TLR2, TLR3, TLR4, TLR5, TLR6, TLR7, TLR8, TLR9, TLR10 and TLR11. Examples of NOD agonists include, but are not limited to, N-acetylmuramyl-L-alanyl-D-isoglutamine (muramyldipeptide (MDP)), gamma-D-glutamyl-meso-diaminopimelic acid (iE-DAP), and desmuramylpeptides (DMP).

[300] The term “isolated” or “enriched” encompasses a microbe, bacteria or other entity or substance that has been (1) separated from at least some of the components with which it was associated when initially produced (whether in nature or in an experimental setting), and/or (2) produced, prepared, purified, and/or manufactured by the hand of man. Isolated microbes may be separated from at least about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, or more of the other components with which they were initially associated. In some embodiments, isolated microbes are more than about 80%, about 85%, about 90%, about 91%, about 92%, about 93%, about 94%, about 95%, about 96%, about 97%, about 98%, about 99%, or more than about 99% pure, e.g., substantially free of other components. The terms “purify,” “purifying” and “purified” refer to a microbe or other material that has been separated from at least some of the components with which it was associated either when initially produced or generated (e.g., whether in nature or in an experimental setting), or during any time after its initial production. A microbe or a microbial population may be considered purified if it is isolated at or after production, such as from a material or environment containing the microbe or microbial population, and a purified microbe or microbial population may contain other materials up to about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, or above about 90% and still be considered “isolated.” In some embodiments, purified microbes or microbial population are more than about 80%, about 85%, about 90%, about 91%, about 92%, about 93%, about 94%, about 95%, about 96%, about 97%, about 98%, about 99%, or more than about 99% pure. In the instance of microbial compositions provided herein, the one or more microbial types present in the composition can be independently purified from one or more other microbes produced and/or present in the material or environment containing the microbial type. Microbial compositions and the microbial components thereof are generally purified from residual habitat products.

[301] “Metabolite” as used herein refers to any and all molecular compounds, compositions, molecules, ions, co-factors, catalysts or nutrients used as substrates in any cellular or microbial metabolic reaction or resulting as product compounds, compositions, molecules, ions, co-factors, catalysts or nutrients from any cellular or microbial metabolic reaction.

[302] “Microbe” refers to any natural or engineered organism characterized as a bacterium, fungus, microscopic alga, protozoan, and the stages of development or life cycle stages (e.g., vegetative, spore (including sporulation, dormancy, and germination), latent, biofilm) associated with the organism. [303] “Microbiome” broadly refers to the microbes residing on or in body site of a subject or patient. Microbes in a microbiome may include bacteria, viruses, eukaryotic microorganisms, and/or viruses. Individual microbes in a microbiome may be metabolically active, dormant, latent, or exist as spores, may exist planktonically or in biofilms, or may be present in the microbiome in sustainable or transient manner. The microbiome may be a commensal or healthy-state microbiome or a disease-state microbiome. The microbiome may be native to the subject or patient, or components of the microbiome may be modulated, introduced, or depleted due to changes in health state or treatment conditions (e.g., antibiotic treatment, exposure to different microbes). In some aspects, the microbiome occurs at a mucosal surface. In some aspects, the microbiome is a gut microbiome.

[304] A “microbiome profile” or a “microbiome signature” of a tissue or sample refers to an at least partial characterization of the bacterial makeup of a microbiome. In some embodiments, a microbiome profile indicates whether at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100 or more bacterial strains are present or absent in a microbiome. In some embodiments, a microbiome profile indicates whether at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100 or more bacterial strains are present in a sample. In some embodiments, the microbiome profile indicates the relative or absolute amount of each bacterial strain detected in the sample.

[305] “Modified” in reference to a bacteria broadly refers to a bacteria that has undergone a change from its wild-type form. Examples of bacterial modifications include genetic modification, gene expression, phenotype modification, formulation, chemical modification, and dose or concentration. Examples of improved properties are described throughout this specification and include, e.g., attenuation, auxotrophy, homing, or antigenicity. Phenotype modification might include, by way of example, bacteria growth in media that modify the phenotype of a bacterium that increase or decrease virulence.

[306] As used herein, a gene is “overexpressed” in a bacteria if it is expressed at a higher level in an engineered bacteria under at least some conditions than it is expressed by a wildtype bacteria of the same species under the same conditions. Similarly, a gene is “underexpressed” in a bacteria if it is expressed at a lower level in an engineered bacteria under at least some conditions than it is expressed by a wild-type bacteria of the same species under the same conditions. [307] The terms “polynucleotide” and “nucleic acid” are used interchangeably. They refer to a polymeric form of nucleotides of any length, either deoxyribonucleotides or ribonucleotides, or analogs thereof. Polynucleotides may have any three-dimensional structure, and may perform any function. The following are non-limiting examples of polynucleotides: coding or non-coding regions of a gene or gene fragment, loci (locus) defined from linkage analysis, exons, introns, messenger RNA (mRNA), micro RNA (miRNA), silencing RNA (siRNA), transfer RNA, ribosomal RNA, ribozymes, cDNA, recombinant polynucleotides, branched polynucleotides, plasmids, vectors, isolated DNA of any sequence, isolated RNA of any sequence, nucleic acid probes, and primers. A polynucleotide may comprise modified nucleotides, such as methylated nucleotides and nucleotide analogs. If present, modifications to the nucleotide structure may be imparted before or after assembly of the polymer. A polynucleotide may be further modified, such as by conjugation with a labeling component. In all nucleic acid sequences provided herein, U nucleotides are interchangeable with T nucleotides.

[308] “Operational taxonomic units” and “OTU(s)” refer to a terminal leaf in a phylogenetic tree and is defined by a nucleic acid sequence, e.g., the entire genome, or a specific genetic sequence, and all sequences that share sequence identity to this nucleic acid sequence at the level of species. In some embodiments the specific genetic sequence may be the 16S sequence or a portion of the 16S sequence. In other embodiments, the entire genomes of two entities are sequenced and compared. In another embodiment, select regions such as multilocus sequence tags (MLST), specific genes, or sets of genes may be genetically compared. For 16S, OTUs that share > 97% average nucleotide identity across the entire 16S or some variable region of the 16S are considered the same OTU. See e.g. Claesson MJ, Wang Q, O’Sullivan O, Greene-Diniz R, Cole JR, Ross RP, and O’Toole PW. 2010. Comparison of two next-generation sequencing technologies for resolving highly complex microbiota composition using tandem variable 16S rRNA gene regions. Nucleic Acids Res 38: e200. Konstantinidis KT, Ramette A, and Tiedje JM. 2006. The bacterial species definition in the genomic era. Philos Trans R Soc Lond B Biol Sci 361 : 1929-1940. For complete genomes, MLSTs, specific genes, other than 16S, or sets of genes OTUs that share > 95% average nucleotide identity are considered the same OTU. See e.g., Achtman M, and Wagner M. 2008. Microbial diversity and the genetic nature of microbial species. Nat. Rev. Microbiol. 6: 431-440. Konstantinidis KT, Ramette A, and Tiedje JM. 2006. The bacterial species definition in the genomic era. Philos Trans R Soc Lond B Biol Sci 361 : 1929-1940. OTUs are frequently defined by comparing sequences between organisms. Generally, sequences with less than 95% sequence identity are not considered to form part of the same OTU. OTUs may also be characterized by any combination of nucleotide markers or genes, in particular highly conserved genes (e.g., “house-keeping” genes), or a combination thereof. Operational Taxonomic Units (OTUs) with taxonomic assignments made to, e.g., genus, species, and phylogenetic clade are provided herein.

[309] As used herein, a substance is “pure” if it is substantially free of other components. The terms “purify,” “purifying,” and “purified” refer to a microbe or other material that has been separated from at least some of the components with which it was associated either when initially produced or generated (e.g., whether in nature or in an experimental setting), or during any time after its initial production. A microbe may be considered purified if it is isolated at or after production, such as from one or more other bacterial components, and a purified microbe or microbial population may contain other materials up to about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, or above about 90% and still be considered “purified.” In some embodiments, purified microbes are more than about 80%, about 85%, about 90%, about 91%, about 92%, about 93%, about 94%, about 95%, about 96%, about 97%, about 98%, about 99%, or more than about 99% pure. Bacterial compositions and the microbial components thereof are, e.g., purified from residual habitat products.

[310] “Residual habitat products” refers to material derived from the habitat for microbiota within or on a subject. For example, microbes live in feces in the gastrointestinal tract, on the skin itself, in saliva, mucus of the respiratory tract, or secretions of the genitourinary tract (i.e., biological matter associated with the microbial community). Substantially free of residual habitat products means that the microbial composition no longer contains the biological matter associated with the microbial environment on or in the human or animal subject and is 100% free, 99% free, 98% free, 97% free, 96% free, or 95% free of any contaminating biological matter associated with the microbial community. Residual habitat products can include abiotic materials (including undigested food) or it can include unwanted microorganisms. Substantially free of residual habitat products may also mean that the microbial composition contains no detectable cells from a human or animal and that only microbial cells are detectable. In one embodiment, substantially free of residual habitat products may also mean that the microbial composition contains no detectable viral (including microbial viruses (e.g., phage)), fungal, mycoplasmal contaminants. In another embodiment, it means that fewer than 1x10-2%, 1x10-3%, 1x10- 4%, 1x10-5%, 1x10-6%, 1x10-7%, 1x10-8% of the viable cells in the microbial composition are human or animal, as compared to microbial cells. There are multiple ways to accomplish this degree of purity, none of which are limiting. Thus, contamination may be reduced by isolating desired constituents through multiple steps of streaking to single colonies on solid media until replicate (such as, but not limited to, two) streaks from serial single colonies have shown only a single colony morphology. Alternatively, reduction of contamination can be accomplished by multiple rounds of serial dilutions to single desired cells (e.g., a dilution of 10-8 or 10-9), such as through multiple 10-fold serial dilutions. This can further be confirmed by showing that multiple isolated colonies have similar cell shapes and Gram staining behavior. Other methods for confirming adequate purity include genetic analysis (e.g., PCR, DNA sequencing), serology and antigen analysis, enzymatic and metabolic analysis, and methods using instrumentation such as flow cytometry with reagents that distinguish desired constituents from contaminants.

[311] The terms “subject” or “patient” refers to any animal. A subject or a patient described as “in need thereof’ refers to one in need of a treatment for a disease. Mammals (z.e., mammalian animals) include humans, laboratory animals (e.g., primates, rats, mice), livestock (e.g., cows, sheep, goats, pigs), and household pets (e.g., dogs, cats, rodents). For example, the subject may be a non-human mammal including but not limited to of a dog, a cat, a cow, a horse, a pig, a donkey, a goat, a camel, a mouse, a rat, a guinea pig, a sheep, a llama, a monkey, a gorilla, or a chimpanzee.

[312] “ Strain” refers to a member of a bacterial species with a genetic signature such that it may be differentiated from closely-related members of the same bacterial species. The genetic signature may be the absence of all or part of at least one gene, the absence of all or part of at least on regulatory region (e.g., a promoter, a terminator, a riboswitch, a ribosome binding site), the absence (“curing”) of at least one native plasmid, the presence of at least one recombinant gene, the presence of at least one mutated gene, the presence of at least one foreign gene (a gene derived from another species), the presence at least one mutated regulatory region (e.g., a promoter, a terminator, a riboswitch, a ribosome binding site), the presence of at least one non-native plasmid, the presence of at least one antibiotic resistance cassette, or a combination thereof. Genetic signatures between different strains may be identified by PCR amplification optionally followed by DNA sequencing of the genomic region(s) of interest or of the whole genome. In the case in which one strain (compared with another of the same species) has gained or lost antibiotic resistance or gained or lost a biosynthetic capability (such as an auxotrophic strain), strains may be differentiated by selection or counter-selection using an antibiotic or nutrient/metabolite, respectively.

[313] As used herein, the term “treating” a disease in a subject or “treating” a subject having or suspected of having a disease refers to subjecting the subject to a pharmaceutical treatment, e.g., the administration of one or more agents, such that at least one symptom of the disease is decreased or prevented from worsening. Thus, in one embodiment, “treating” refers inter alia to delaying progression, expediting remission, inducing remission, augmenting remission, speeding recovery, increasing efficacy of or decreasing resistance to alternative therapeutics, or a combination thereof. The methods and compositions described herein can be used to treat any subject in need thereof. As used herein, a “subject in need thereof’ includes any subject that has, or has been diagnosed as having, a disease or disorder disclosed herein and/or treatable by a method or composition disclosed herein, as well as any subject with an increased likelihood of acquiring a such a disease or disorder.

Bacteria

[314] In some aspects, provided herein are bacterial compositions (e.g., pharmaceutical compositions) (e.g., solid dosage forms thereof) comprising Prevotella histicola useful for the treatment and/or prevention of inflammation (e.g., Thl, Th2, or Thl7 inflammation) and methods of using such bacterial compositions (e.g., for the treatment of inflammation (e.g., Thl, Th2, or Thl7 inflammation)), e.g., in a subject, e.g., in a human subject. In some embodiments, the bacterial compositions comprise whole Prevotella histicola bacteria (e.g., live bacteria, non-live bacteria, killed bacteria, and/or attenuated bacteria). In some embodiments, the Prevotella histicola bacteria are non-live. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprises only one strain of bacteria, e.g., Prevotella histicola.

[315] In some aspects, provided herein are bacterial compositions (e.g., pharmaceutical compositions) (e.g., solid dosage forms thereof) comprising Prevotella histicola useful for the treatment and/or prevention of psoriasis (e.g., mild to moderate psoriasis) and methods of using such bacterial compositions (e.g., for the treatment of psoriasis), e.g., in a subject, e.g., in a human subject. In some embodiments, the bacterial compositions comprise whole Prevotella histicola bacteria (e.g., live bacteria, non-live bacteria, killed bacteria, attenuated bacteria). In some embodiments, the Prevotella histicola bacteria are non-live. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprises only one strain of bacteria, e.g., Prevotella histicola.

[316] In some aspects, provided herein are bacterial compositions (e.g., pharmaceutical compositions) (e.g., solid dosage forms thereof) comprising Prevotella histicola useful for the treatment and/or prevention of atopic dermatitis (e.g., mild, moderate, or severe atopic dermatitis) and methods of using such bacterial compositions (e.g., for the treatment of atopic dermatitis), e.g., in a subject, e.g., in a human subject. In some embodiments, the bacterial compositions comprise whole Prevotella histicola bacteria (e.g., live bacteria, non-live bacteria, killed bacteria, attenuated bacteria). In some embodiments, the Prevotella histicola bacteria are non-live. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprises only one strain of bacteria, e.g., Prevotella histicola.

[317] In some aspects, provided herein are bacterial compositions (e.g., pharmaceutical compositions) (e.g., solid dosage forms thereof) comprising Prevotella histicola useful for the treatment and/or prevention of psoriatic arthritis and methods of using such bacterial compositions (e.g., for the treatment of psoriatic arthritis), e.g., in a subject, e.g., in a human subject. In some embodiments, the bacterial compositions comprise whole Prevotella histicola bacteria (e.g., live bacteria, non-live bacteria, killed bacteria, attenuated bacteria). In some embodiments, the Prevotella histicola bacteria are non-live. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprises only one strain of bacteria, e.g., Prevotella histicola.

[318] In some embodiments, the Prevotella histicola is Prevotella Strain B 50329 (NRRL accession number B 50329) (also referred to as “Prevotella histicola Strain B” or “Prevotella Strain B”). In some embodiments, the Prevotella strain is a strain comprising at least 85%, at least 86%, at least 87%, at least 88%, at least 89%, at least 90%, at least 91%, at least 92%, at least 93%, at least 94%, at least 95%, at least 96%, at least 97%, at least 98%, or at least 99% sequence identity (e.g., at least 99.5% sequence identity, at least 99.6% sequence identity, at least 99.7% sequence identity, at least 99.8% sequence identity, at least 99.9% sequence identity) to the nucleotide sequence (e.g., genomic sequence, 16S sequence, CRISPR sequence) of the Prevotella Strain B 50329.

[319] Prevotella histicola Strain B can be cultured according to methods known in the art. For example, Prevotella histicola can be grown in ATCC Medium 2722, ATCC Medium 1490, or other medium using methods disclosed, for example in Caballero et al., 2017. “Cooperating Commensals Restore Colonization Resistance to Vancomycin-Resistant Enterococcus faecium” Cell Host & Microbe 21 : 592-602, which is hereby incorporated by reference in its entirety.

[320] In some embodiments, the Prevotella bacteria (e.g., in a bacterial composition) are quantified based on total cells, e.g., total cell count (TCC) (e.g., determined by Coulter counter).

[321] In some embodiments, the bacterial composition is administered once daily for at least 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. In some embodiments, the bacterial composition is administered once daily for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks.

[322] In some embodiments, the bacterial composition is administered twice daily for at least 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. In some embodiments, the bacterial composition is administered twice daily for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks.

[323] In some embodiments, the bacterial composition is formulated as a solid dosage form, e.g., a capsule or a tablet. In some embodiments, the solid dosage form (e.g., of the composition) comprises an enteric coating. In some embodiments, the solid dosage form comprises a capsule. In some embodiments, the capsule is an enteric coated capsule. In some embodiments, the tablet is an enteric coated tablet. In some embodiments, the solid dosage form comprises a tablet. In some embodiments, the enteric coating allows release of the bacterial composition in the small intestine, e.g., in the upper small intestine, e.g., in the duodenum.

[324] In some embodiments, the subject is a mammal. In some embodiments, the subject is a human. In some embodiments, the subject is a non-human mammal (e.g., a dog, a cat, a cow, a horse, a pig, a donkey, a goat, a camel, a mouse, a rat, a guinea pig, a sheep, a llama, a monkey, a gorilla, or a chimpanzee).

Bacterial Compositions

[325] A “bacterial composition” can be, e.g., a pharmaceutical composition. A bacterial composition contains bacteria. A bacterial composition can be, e.g., a solution or dried form (for example, powder (such as a lyophilized powder or spray-dried powder) or lyophilate (for example, lyophilized powder or lyophilized cake)) that comprises bacteria. In some embodiments, the bacterial composition is a pharmaceutical composition. In some embodiments, the bacterial composition is (or is present in) a medicinal product, medical food, food product, or dietary supplement. In some embodiments, a bacterial composition provides a therapeutically effective amount of bacteria contained therein.

[326] In some embodiments, the methods provided herein comprise use of bacterial compositions (e.g., pharmaceutical compositions) comprising Prevotella histicola bacteria provided herein.

[327] In some embodiments, the bacterial compositions comprise whole Prevotella histicola bacteria (e.g., live bacteria, non-live bacteria, killed bacteria, and/or attenuated bacteria). In some embodiments, the Prevotella histicola bacteria are non-viable (e.g., less than about 1% of the bacteria (e.g., of a composition) are viable). In some embodiments, the Prevotella histicola bacteria have been gamma irradiated (e.g., according to a method described herein). In some embodiments, the Prevotella histicola bacteria are live. In some embodiments, the Prevotella histicola bacteria are non-live (e.g., less than about 1% of the bacteria (e.g., of a composition) are live). For example, non-live bacteria do not form colonies when plated (e.g., do not have colony forming units (CFUs) (e.g., when plated in conditions that allow growth) (e.g., less than about 1% of the bacteria (e.g., of a composition) form colonies when plated).

[328] In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprises only one strain of bacteria, e.g., Prevotella histicola.

[329] In some embodiments, the Prevotella histicola is Prevotella Strain B 50329 (NRRL accession number B 50329). In some embodiments, the Prevotella strain is a strain comprising at least 85%, at least 86%, at least 87%, at least 88%, at least 89%, at least 90%, at least 91%, at least 92%, at least 93%, at least 94%, at least 95%, at least 96%, at least 97%, at least 98%, or at least 99% sequence identity (e.g., at least 99.5% sequence identity, at least 99.6% sequence identity, at least 99.7% sequence identity, at least 99.8% sequence identity, at least 99.9% sequence identity) to the nucleotide sequence (e.g., genomic sequence, 16S sequence, CRISPR sequence) of the Prevotella Strain B 50329.

[330] In some embodiments, the bacterial compositions comprise whole Prevotella histicola bacteria (e.g., live bacteria, non-live bacteria, killed bacteria, attenuated bacteria).

[331] In some embodiments, the bacterial composition is formulated as a capsule or a tablet. In some embodiments, the bacterial composition comprises an enteric coating or micro encapsulation. In some embodiments, the bacterial composition is prepared as a capsule. In some embodiments, the capsule is an enteric coated capsule. In some embodiments, the bacterial composition is prepared as a tablet. In some embodiments, the tablet is an enteric coated tablet. In some embodiments, the enteric coating allows release of the bacterial composition in the small intestine, e.g., in the upper small intestine, e.g., in the duodenum.

[332] In some embodiments, the bacterial composition comprises about 50 mg to about 3 g of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[333] In some embodiments, the bacterial composition comprises about 55mg, about 550 mg, or about 2.76 g of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[334] In some embodiments, the bacterial composition comprises about 2 x IO¹⁰, 2.1 x

10¹⁰, 2.2 x IO¹⁰, 2.3 x IO¹⁰, 2.4 x IO¹⁰, 2.5 x IO¹⁰, 2.6 x IO¹⁰, 2.7 x IO¹⁰, 2.8 x IO¹⁰, 2.9 x IO¹⁰, 3 x IO¹⁰, 3.1 x IO¹⁰, 3.2 x IO¹⁰, 3.3 x IO¹⁰, 3.4 x IO¹⁰, 3.5 x IO¹⁰, 3.6 x IO¹⁰, 3.7 x IO¹⁰,

3.8 x IO¹⁰, 3.9 x IO¹⁰, 4 x IO¹⁰, 5 x IO¹⁰, 6 x IO¹⁰, 7 x IO¹⁰, 8 x IO¹⁰, 9 x IO¹⁰, 1 x 10¹¹, 1.1 x

10¹¹, 1.2 x 10¹¹, 1.3 x 10¹¹, 1.4 x 10¹¹, 1.5 x 10¹¹, 1.6 x 10¹¹, 1.7 x 10¹¹, 1.8 x 10¹¹, 1.9 x 10¹¹, 2 x 10¹¹, 2.1 x 10¹¹, 2.2 x 10¹¹, 2.3 x 10¹¹, 2.4 x 10¹¹, 2.5 x 10¹¹, 2.6 x 10¹¹, 2.7 x 10¹¹,

2.8 x 10¹¹, 2.9 x 10¹¹, 3 x 10¹¹, 3.1 x 10¹¹, 3.2 x 10¹¹, 3.3 x 10¹¹, 3.4 x 10¹¹, 3.5 x 10¹¹, 3.6 x 10¹¹, 3.7 x 10¹¹, 3.8 x 10¹¹, 3.9 x 10¹¹, 4 x 10¹¹ 5 x 10¹¹, 6 x 10¹¹, 7 x 10¹¹, 8 x 10¹¹, 9 x 10¹¹, 1 x 10¹², 1.5 x 10¹² total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329. In some embodiments, the bacterial composition comprises about 8xlO¹⁰ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329. In some embodiments, the bacterial composition comprises about 1.6 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329. In some embodiments, the bacterial composition comprises about 3.2 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329. In some embodiments, the bacterial composition comprises about 6.4 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329. In some embodiments, the bacterial composition comprises about 8 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329. In some embodiments, the bacterial composition comprises about 9.6 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329. In some embodiments, the bacterial composition comprises about 12.8 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329. In some embodiments, the bacterial composition comprises about 16 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329. In some embodiments, the bacterial composition comprises about 1.6 x IO¹⁰ to about 1.6 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329. In some embodiments, the bacterial composition comprises about 1.6 x 10¹⁰ to about 16 x IO¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329. In some embodiments, the bacterial composition comprises about 8 x IO¹⁰ to about 8 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329. In some embodiments, the bacterial composition comprises about 8 x IO¹⁰ to about 1.6 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329. In some embodiments, the bacterial composition comprises about 3.2 x IO¹⁰ to about 9.6 x IO¹⁰ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329. In some embodiments, the bacterial composition comprises about 4.8 x IO¹⁰ to about 9.6 x IO¹⁰ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329. In some embodiments, the bacterial composition comprises about 6.4 x 10¹⁰ to about 9.6 x 10¹⁰ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329. In some embodiments, the bacterial composition comprises about 1.6 x 10¹¹ to about 8 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329. In some embodiments, the bacterial composition comprises about 9.6 x 10¹¹ to about 16 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329. In some embodiments, the bacterial composition comprises about 9.6 x 10¹¹ to about 12.8 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329. In some embodiments, the bacterial composition comprises about 12.8 x 10¹¹ to about 16 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329. Herein, total cells is determined by total cell count (e.g., determined by Coulter counter).

[335] In some embodiments, the bacterial composition comprises about 1.6 x 10¹⁰ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[336] In some embodiments, the bacterial composition comprises about 8 x 10¹⁰ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[337] In some embodiments, the bacterial composition comprises about 1.6 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[338] In some embodiments, the bacterial composition comprises about 3.2 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[339] In some embodiments, the bacterial composition comprises about 6.4 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[340] In some embodiments, the bacterial composition comprises about 8 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[341] In some embodiments, the bacterial composition comprises about 1.6 x 10¹⁰ to about 8 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329. [342] In some embodiments, the bacterial composition comprises about 1.6 x IO¹⁰ to about

1.6 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[343] In some embodiments, the bacterial composition comprises about 1.6 x 10¹¹ to about 8 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[344] In some embodiments, the bacterial composition comprises about 8 x IO¹⁰ to about 8 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[345] In some embodiments, the bacterial composition comprises about 3.2 x IO¹⁰ to about

9.6 x IO¹⁰ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[346] In some embodiments, the bacterial composition comprises about 4.8 x IO¹⁰ to about

[347] In some embodiments, the bacterial composition comprises about 6.4 x 10¹⁰ to about

9.6 x 10¹⁰ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[348] In some embodiments, the bacterial composition, e.g., bacterial composition (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 8 x

10¹⁰ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[349] In some embodiments, the bacterial composition, e.g., bacterial composition (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 1.6 x

10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[350] In some embodiments, the bacterial composition, e.g., bacterial composition (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 3.2 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[351] In some embodiments, the bacterial composition, e.g., bacterial composition (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 6.4 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[352] In some embodiments, the bacterial composition, e.g., bacterial composition (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 8 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[353] In some embodiments, the bacterial composition, e.g., bacterial composition (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 9.6 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[354] In some embodiments, the bacterial composition, e.g., bacterial composition (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 12.8 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329. [355] In some embodiments, the bacterial composition, e.g., bacterial composition (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 16 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[356] In some embodiments, the bacterial composition, e.g., bacterial composition (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 9.6 x 10¹¹ to about 16 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[357] In some embodiments, the bacterial composition, e.g., bacterial composition (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 9.6 x 10¹¹ to about 12.8 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[358] In some embodiments, the bacterial composition, e.g., bacterial composition (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 12.8 x 10¹¹ to about 16 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[359] In some embodiments, the bacterial composition comprising Pre votella bacteria is prepared as a powder (e.g., for resuspension or for use in a solid dose form (such as a capsule)) or as a solid dose form, such as a tablet, a mini-tablet, a capsule, a pill, or a powder; or a combination of these forms (e.g., mini-tablets comprised in a capsule). The powder can comprise lyophilized bacteria. In some embodiments, the powder further comprises mannitol, magnesium stearate, and/or colloidal silicon dioxide.

[360] In some embodiments, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 solid dosage forms are administered, e.g., once or twice daily to a subject.

[361] In some embodiments, 1 solid dosage form (e.g., tablet or capsule) is administered (e.g., is for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 1.6 x 10¹⁰ total cells. In some embodiments, 2 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form (e.g., each solid dose form) comprises a dose of bacteria of about 1.6 x 10¹⁰ total cells. In some embodiments, 3 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 1.6 x 10¹⁰ total cells. In some embodiments, 4 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 1.6 x 10¹⁰ total cells. In some embodiments, 5 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 1.6 x IO¹⁰ total cells. In some embodiments, 6 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 1.6 x IO¹⁰ total cells. In some embodiments, 8 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 1.6 x IO¹⁰ total cells. In some embodiments, 10 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 1.6 x 10¹⁰total cells.

[362] In some embodiments, 1 solid dosage form (e.g., tablet or capsule) is administered (e.g., is for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 8 x IO¹⁰ total cells. In some embodiments, 2 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form (e.g., each solid dose form) comprises a dose of bacteria of about 8 x IO¹⁰ total cells. In some embodiments, 3 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 8 x IO¹⁰ total cells. In some embodiments, 4 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 8 x IO¹⁰ total cells. In some embodiments, 5 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 8 x IO¹⁰ total cells. In some embodiments, 6 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 8 x IO¹⁰ total cells. In some embodiments, 8 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 8 x IO¹⁰ total cells. In some embodiments, 10 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 8 x IO¹⁰ total cells.

[363] In some embodiments, 1 solid dosage form (e.g., tablet or capsule) is administered (e.g., is for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 1.6 x 10¹¹ total cells. In some embodiments, 2 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form (e.g., each solid dose form) comprises a dose of bacteria of about 1.6 x 10¹¹ total cells. In some embodiments, 3 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 1.6 x 10¹¹ total cells. In some embodiments, 4 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 1.6 x 10¹¹ total cells. In some embodiments, 5 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 1.6 x 10¹¹ total cells. In some embodiments, 6 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 1.6 x 10¹¹ total cells. In some embodiments, 8 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 1.6 x 10¹¹ total cells. In some embodiments, 10 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 1.6 x 10¹¹ total cells.

[364] In some embodiments, 1 solid dosage form (e.g., tablet or capsule) is administered (e.g., is for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 3.2 x 10¹¹ total cells. In some embodiments, 2 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form (e.g., each solid dose form) comprises a dose of bacteria of about 3.2 x 10¹¹ total cells. In some embodiments, 3 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 3.2 x 10¹¹ total cells. In some embodiments, 4 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 3.2 x 10¹¹ total cells. In some embodiments, 5 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 3.2 x 10ⁿtotal cells. In some embodiments, 6 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 3.2 x 10¹¹ total cells. In some embodiments, 8 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 3.2 x 10¹¹ total cells. In some embodiments, 10 solid dosage forms (e.g., tablets or capsules) are administered (e.g., are for administration) e.g., once or twice daily to a subject, wherein the solid dosage form comprises a dose of bacteria of about 3.2 x 10¹¹ total cells. For clarity, about 3.2 x 10¹¹ total cells includes total cell counts within ±5% of 3.2 x 10¹¹ total cells e.g., 3.35 x 10¹¹ total cells.

[365] In some embodiments, the bacterial composition is prepared as a solid dosage form. In some embodiments, provided herein are solid dosage forms comprising the Prevotella histicola bacteria. In some embodiments, the solid dosage form comprises an enteric coating. In some embodiments, the solid dosage form is a tablet, e.g., an enteric coated tablet. In some embodiments, each tablet comprises about 8 x IO¹⁰ total cells of the Prevotella histicola bacteria. In some embodiments, each tablet comprises about 1.6 x 10¹¹ total cells of the Prevotella histicola bacteria. In some embodiments, each tablet comprises about 3.2 x 10¹¹ total cells of the Prevotella histicola bacteria. In some embodiments, the solid dosage form is a capsule, e.g., an enteric coated capsule. In some embodiments, each capsule comprises about 8 x IO¹⁰ total cells of the Prevotella histicola bacteria. In some embodiments, each capsule comprises about 1.6 x 10¹¹ total cells of the Prevotella histicola bacteria. In some embodiments, each capsule comprises about 3.2 x 10¹¹ total cells of the Prevotella histicola bacteria.

[366] In some embodiments, the bacterial composition, e.g., pharmaceutical composition is a powder. The powder can be resuspended (e.g., in a liquid such as a solution, buffer, water or other beverage or a food), e.g., for administration to a subject. [367] In some embodiments, a dose of Prevotella histicola bacteria of about 8 x IO¹⁰ total cells are administered (e.g., are for administration) per day.

[368] In some embodiments, a dose of Prevotella histicola bacteria of about 1.6 x 10¹¹ total cells are administered (e.g., are for administration) per day.

[369] In some embodiments, a dose of Prevotella histicola bacteria of about 3.2 x 10¹¹ total cells are administered (e.g., are for administration) per day.

[370] In some embodiments, a dose of Prevotella histicola bacteria of about 6.4 x 10¹¹ total cells are administered (e.g., are for administration) per day.

[371] In some embodiments, a dose of Prevotella histicola bacteria of about 8 x 10¹¹ total cells are administered (e.g., are for administration) per day.

[372] In some embodiments, a dose of Prevotella histicola bacteria of about 9.6 x 10¹¹ total cells are administered (e.g., are for administration) per day.

[373] In some embodiments, a dose of Prevotella histicola bacteria of about 12.8 x 10¹¹ total cells are administered (e.g., are for administration) per day.

[374] In some embodiments, a dose of Prevotella histicola bacteria of about 16 x 10¹¹ total cells are administered (e.g., are for administration) per day.

[375] In some embodiments, the solid dosage form is a tablet. In some embodiments, the tablet is an enteric coated tablet. In some embodiments, the enteric coated tablet is from 5mm to 18mm in diameter (size refers to size prior to application of enteric coat). In some embodiments, the tablet comprises about 8 x IO¹⁰ total cells of the Prevotella bacteria. In some embodiments, the tablet comprises about 1.6 x 10¹¹ total cells of the Prevotella bacteria. In some embodiments, the tablet comprises about 3.2 x 10¹¹ total cells of the Prevotella bacteria. In some embodiments, the Prevotella bacteria in the tablet are lyophilized.

[376] In some embodiments, the solid dosage form is a capsule. In some embodiments, the capsule is an enteric coated capsule. In some embodiments, the enteric coated capsule is a size 00, size 0, size 1, size 2, size 3, size 4, or size 5 capsule. In some embodiments, the capsule is a size 0 capsule. In some embodiments, the capsule comprises about 8 x IO¹⁰ total cells of the Prevotella bacteria. In some embodiments, the capsule comprises about 1.6 x 10¹¹ total cells of the Prevotella bacteria. In some embodiments, the capsule comprises about 3.2 x 10¹¹ total cells of the Prevotella bacteria. In some embodiments, the Prevotella bacteria in the capsule are lyophilized. In some embodiments, the capsule comprises gelatin. In some embodiments, the capsule comprises HPMC. [377] In some embodiments, provided herein are solid dosage forms comprising the Prevotella bacteria. In some embodiments, the solid dosage form is a tablet, e.g., an enteric coated tablet. In some embodiments, the solid dosage form is a capsule, e.g., an enteric coated capsule. In some embodiments, the enteric coating comprises a polymethacrylate- based copolymer. In some embodiments, the enteric coating comprises a methacrylic acid ethyl acrylate (MAE) copolymer (1 : 1). In some embodiments, the enteric coating comprises methacrylic acid ethyl acrylate (MAE) copolymer (1 : 1) (such as Kollicoat MAE 100P or Eudragit L30-D55).

[378] In some embodiments, each tablet comprises about 8 x IO¹⁰ total cells of the Prevotella bacteria. In some embodiments, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 tablets are administered, e.g., once or twice daily to a subject. In some embodiments, 1 tablet (e.g., comprising about 8 x IO¹⁰ total cells) is administered, e.g., once or twice daily to a subject. In some embodiments, 2 tablets (e.g., each comprising about 8 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 3 tablets (e.g., each comprising about 8 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 4 tablets (e.g., each comprising about 8 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 5 tablets (e.g., each comprising about 8 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 6 tablets (e.g., each comprising about 8 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 8 tablets (e.g., each comprising about 8 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 10 tablets (e.g., each comprising about 8 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject.

[379] In some embodiments, each tablet comprises about 1.6 x 10¹¹ total cells of the Prevotella bacteria. In some embodiments, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 tablets are administered, e.g., once or twice daily to a subject. In some embodiments, 1 tablet (e.g., comprising about 1.6 x 10¹¹ total cells) is administered, e.g., once or twice daily to a subject. In some embodiments, 2 tablets (e.g., each comprising about 1.6 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 3 tablets (e.g., each comprising about 1.6 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 4 tablets (e.g., each comprising about 1.6 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 5 tablets (e.g., each comprising about 1.6 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 6 tablets (e.g., each comprising about 1.6 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 8 tablets (e.g., each comprising about 1.6 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 10 tablets (e.g., each comprising about 1.6 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject.

[380] In some embodiments, each tablet comprises about 3.2 x 10ⁿtotal cells of the Prevotella bacteria. In some embodiments, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 tablets are administered, e.g., once or twice daily to a subject. In some embodiments, 1 tablet (e.g., comprising about 3.2 x 10¹¹ total cells) is administered, e.g., once or twice daily to a subject. In some embodiments, 2 tablets (e.g., each comprising about 3.2 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 3 tablets (e.g., each comprising about 3.2 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 4 tablets (e.g., each comprising about 3.2 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 5 tablets (e.g., each comprising about 3.2 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 6 tablets (e.g., each comprising about 3.2 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 8 tablets (e.g., each comprising about 3.2 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 10 tablets (e.g., each comprising about 3.2 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject.

[381] In some embodiments, each capsule comprises about 1.6 x IO¹⁰ total cells of the Prevotella bacteria. In some embodiments, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 capsules are administered, e.g., once or twice daily to a subject. In some embodiments, 1 capsule (e.g., comprising about 1.6 x 10¹⁰ total cells) is administered, e.g., once or twice daily to a subject. In some embodiments, 2 capsules (e.g., each comprising about 1.6 x 10¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 3 capsules (e.g., each comprising about 1.6 x 10¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 4 capsules (e.g., each comprising about 1.6 x 10¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 5 capsules (e.g., each comprising about 1.6 x 10¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 6 capsules (e.g., each comprising about 1.6 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 8 capsules (e.g., each comprising about 1.6 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 10 capsules (e.g., each comprising about 1.6 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject.

[382] In some embodiments, each capsule comprises about 8 x IO¹⁰ total cells of the Prevotella bacteria. In some embodiments, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 capsules are administered, e.g., once or twice daily to a subject. In some embodiments, 1 capsule (e.g., comprising about 8 x IO¹⁰ total cells) is administered, e.g., once or twice daily to a subject. In some embodiments, 2 capsules (e.g., each comprising about 8 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 3 capsules (e.g., each comprising about 8 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 4 capsules (e.g., each comprising about 8 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. . In some embodiments, 5 capsules (e.g., each comprising about 8 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 6 capsules (e.g., each comprising about 8 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 8 capsules (e.g., each comprising about 8 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 10 capsules (e.g., each comprising about 8 x IO¹⁰ total cells) are administered, e.g., once or twice daily to a subject.

[383] In some embodiments, each capsule comprises about 1.6 x 10¹¹ total cells of the Prevotella bacteria. In some embodiments, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 capsules are administered, e.g., once or twice daily to a subject. In some embodiments, 1 capsule (e.g., comprising about 1.6 x 10¹¹ total cells) is administered, e.g., once or twice daily to a subject. In some embodiments, 2 capsules (e.g., each comprising about 1.6 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 3 capsules (e.g., each comprising about 1.6 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 4 capsules (e.g., each comprising about 1.6 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 5 capsules (e.g., each comprising about 1.6 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 6 capsules (e.g., each comprising about 1.6 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 8 capsules (e.g., each comprising about 1.6 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 10 capsules (e.g., each comprising about 1.6 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject.

[384] In some embodiments, each capsule comprises about 3.2 x 10¹¹ total cells of the Prevotella bacteria. In some embodiments, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 capsules are administered, e.g., once or twice daily to a subject. In some embodiments, 1 capsule (e.g., comprising about 3.2 x 10¹¹ total cells) is administered, e.g., once or twice daily to a subject. In some embodiments, 2 capsules (e.g., each comprising about 3.2 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 3 capsules (e.g., each comprising about 3.2 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 4 capsules (e.g., each comprising about 3.2 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 5 capsules (e.g., each comprising about 3.2 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 6 capsules (e.g., each comprising about 3.2 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 8 capsules (e.g., each comprising about 3.2 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject. In some embodiments, 10 capsules (e.g., each comprising about 3.2 x 10¹¹ total cells) are administered, e.g., once or twice daily to a subject.

[385] In some embodiments, the Prevotella bacteria in the capsule are lyophilized (e.g., in a powder). In some embodiments, the Prevotella bacteria in the capsule are lyophilized in a powder, and the powder further comprises mannitol, magnesium stearate, and/or colloidal silicon dioxide.

[386] In some embodiments, at least 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98% or 99% of the bacteria in the composition are of the Prevotella strain. In some embodiments, at least 99% of the bacteria in the composition are of the Prevotella strain. In some embodiments, the bacteria in the composition are essentially (e.g., about 100%) of the Prevotella strain.

[387] In some embodiments, about 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%,

11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%,

26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%,

41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%, 51%, 52%, 53%, 54%, 55%,

56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98% or 99% of the protein in the pharmaceutical composition is Prevotella strain bacteria protein.

[388] In some embodiments, the Prevotella bacteria may be quantified based on total cells, e.g., total cell count (TCC) (e.g., determined by Coulter counter).

[389] In some embodiments, the bacterial composition is administered orally. In some embodiments, the administration to the subject once daily. In some embodiments, the bacterial composition is administered in 2 or more doses (e.g., 3 or more, 4 or more or 5 or more doses). In some embodiments, the administration to the subject of the two or more doses are separated by at least 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, 12 hours, 13 hours, 14 hours, 15 hours, 16 hours, 17 hours, 18 hours, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, 10 days, 11 days, 12 days, 13 days, 14 days, 15 days, 16 days, 17 days, 18 days, 19 days, 20 days or 21 days.

[390] In some embodiments, the bacterial composition is administered once daily for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. In some embodiments, the bacterial composition is administered once daily for at least 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks.

[391] In some embodiments, the bacterial composition is administered twice daily for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. In some embodiments, the bacterial composition is administered once daily for at least 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks.

[392] In some embodiments, the bacterial composition is formulated as a tablet. In some embodiments, the bacterial composition is formulated as a capsule. In some embodiments, the bacterial formulation (e.g., composition) comprises an enteric coating or micro encapsulation. In some embodiments, the enteric coating allows release of the bacterial composition in the small intestine, e.g., in the upper small intestine, e.g., in the duodenum.

[393] In some embodiments, the subject is a mammal. In some embodiments, the subject is a human. In some embodiments, the subject is a non-human mammal (e.g., a dog, a cat, a cow, a horse, a pig, a donkey, a goat, a camel, a mouse, a rat, a guinea pig, a sheep, a llama, a monkey, a gorilla, or a chimpanzee).

[394] In some embodiments, the bacterial composition comprises an enteric coating or micro encapsulation. In some embodiments, the enteric coating or micro encapsulation improves targeting to a desired region of the gastrointestinal tract. For example, in some embodiments, the bacterial composition comprises an enteric coating and/or microcapsules that dissolves at a pH associated with a particular region of the gastrointestinal tract. In some embodiments, the enteric coating and/or microcapsules dissolve at a pH of about 5.5 - 6.2 to release in the duodenum, at a pH value of about 7.2 - 7.5 to release in the ileum, and/or at a pH value of about 5.6 - 6.2 to release in the colon. Exemplary enteric coatings and microcapsules are described, for example, in U.S. Pat. Pub. No. 2016/0022592, which is hereby incorporated by reference in its entirety.

[395] In some aspects, provided are bacterial compositions for administration to subjects. In some embodiments, the bacterial compositions are combined with additional active and/or inactive materials in order to produce a final product, which may be in single dosage unit or in a multi-dose format. In some embodiments, the bacterial compositions is combined with an adjuvant such as an immuno-adjuvant (e.g., STING agonists, TLR agonists, NOD agonists).

[396] In some embodiments, the bacterial composition comprises at least one carbohydrate. A “carbohydrate” refers to a sugar or polymer of sugars. The terms “saccharide,” “polysaccharide,” “carbohydrate,” and “oligosaccharide” may be used interchangeably. Most carbohydrates are aldehydes or ketones with many hydroxyl groups, usually one on each carbon atom of the molecule. Carbohydrates generally have the molecular formula CiJhnOn. A carbohydrate may be a monosaccharide, a disaccharide, tri saccharide, oligosaccharide, or polysaccharide. The most basic carbohydrate is a monosaccharide, such as glucose, sucrose, galactose, mannose, ribose, arabinose, xylose, and fructose. Disaccharides are two joined monosaccharides. Exemplary disaccharides include sucrose, maltose, cellobiose, and lactose. Typically, an oligosaccharide includes between three and six monosaccharide units (e.g., raffinose, stachyose), and polysaccharides include six or more monosaccharide units. Exemplary polysaccharides include starch, glycogen, and cellulose. Carbohydrates may contain modified saccharide units such as 2’ -deoxyribose wherein a hydroxyl group is removed, 2’-fluororibose wherein a hydroxyl group is replaced with a fluorine, or N-acetylglucosamine, a nitrogen-containing form of glucose (e.g., 2’-fluororibose, deoxyribose, and hexose). Carbohydrates may exist in many different forms, for example, conformers, cyclic forms, acyclic forms, stereoisomers, tautomers, anomers, and isomers. [397] In some embodiments, the bacterial composition comprises at least one lipid. As used herein a “lipid” includes fats, oils, triglycerides, cholesterol, phospholipids, fatty acids in any form including free fatty acids. Fats, oils and fatty acids can be saturated, unsaturated (cis or trans) or partially unsaturated (cis or trans). In some embodiments the lipid comprises at least one fatty acid selected from lauric acid (12:0), myristic acid (14:0), palmitic acid (16:0), palmitoleic acid (16: 1), margaric acid (17:0), heptadecenoic acid (17: 1), stearic acid (18:0), oleic acid (18: 1), linoleic acid (18:2), linolenic acid (18:3), octadecatetraenoic acid (18:4), arachidic acid (20:0), eicosenoic acid (20:1), eicosadienoic acid (20:2), eicosatetraenoic acid (20:4), eicosapentaenoic acid (20:5) (EP A), docosanoic acid (22:0), docosenoic acid (22: 1), docosapentaenoic acid (22:5), docosahexaenoic acid (22:6) (DHA), and tetracosanoic acid (24:0). In some embodiments the composition comprises at least one modified lipid, for example a lipid that has been modified by cooking.

[398] In some embodiments, the bacterial composition comprises at least one supplemental mineral or mineral source. Examples of minerals include, without limitation: chloride, sodium, calcium, iron, chromium, copper, iodine, zinc, magnesium, manganese, molybdenum, phosphorus, potassium, and selenium. Suitable forms of any of the foregoing minerals include soluble mineral salts, slightly soluble mineral salts, insoluble mineral salts, chelated minerals, mineral complexes, non-reactive minerals such as carbonyl minerals, and reduced minerals, and combinations thereof.

[399] In some embodiments, the bacterial composition comprises at least one supplemental vitamin. The at least one vitamin can be fat-soluble or water-soluble vitamins. Suitable vitamins include but are not limited to vitamin C, vitamin A, vitamin E, vitamin B12, vitamin K, riboflavin, niacin, vitamin D, vitamin B6, folic acid, pyridoxine, thiamine, pantothenic acid, and biotin. Suitable forms of any of the foregoing are salts of the vitamin, derivatives of the vitamin, compounds having the same or similar activity of the vitamin, and metabolites of the vitamin.

[400] In some embodiments, the bacterialcomposition comprises an excipient. Nonlimiting examples of suitable excipients include a buffering agent, a preservative, a stabilizer, a binder, a compaction agent, a lubricant, a dispersion enhancer, a disintegration agent, a flavoring agent, a sweetener, and a coloring agent. [401] In some embodiments, the excipient is a buffering agent. Non-limiting examples of suitable buffering agents include sodium citrate, magnesium carbonate, magnesium bicarbonate, calcium carbonate, and calcium bicarbonate.

[402] In some embodiments, the excipient comprises a preservative. Non-limiting examples of suitable preservatives include antioxidants, such as alpha-tocopherol and ascorbate, and antimicrobials, such as parabens, chlorobutanol, and phenol.

[403] In some embodiments, the bacterial composition comprises a binder as an excipient. Non-limiting examples of suitable binders include starches, pregelatinized starches, gelatin, polyvinylpyrolidone, cellulose, methylcellulose, sodium carboxymethylcellulose, ethylcellulose, polyacrylamides, polyvinyloxoazolidone, polyvinylalcohols, C12-C18 fatty acid alcohol, polyethylene glycol, polyols, saccharides, oligosaccharides, and combinations thereof.

[404] In some embodiments, the bacterial composition comprises a lubricant as an excipient. Non-limiting examples of suitable lubricants include magnesium stearate, calcium stearate, zinc stearate, hydrogenated vegetable oils, sterotex, polyoxyethylene monostearate, talc, polyethyleneglycol, sodium benzoate, sodium lauryl sulfate, magnesium lauryl sulfate, and light mineral oil.

[405] In some embodiments, the bacterial composition comprises a dispersion enhancer as an excipient. Non-limiting examples of suitable dispersants include starch, alginic acid, polyvinylpyrrolidones, guar gum, kaolin, bentonite, purified wood cellulose, sodium starch glycolate, isoamorphous silicate, and microcrystalline cellulose as high HLB emulsifier surfactants.

[406] In some embodiments, the bacterial composition comprises a disintegrant as an excipient. In some embodiments the disintegrant is a non-effervescent disintegrant. Nonlimiting examples of suitable non-effervescent disintegrants include starches such as com starch, potato starch, pregelatinized and modified starches thereof, sweeteners, clays, such as bentonite, micro-crystalline cellulose, alginates, sodium starch glycolate, gums such as agar, guar, locust bean, karaya, pectin, and tragacanth. In some embodiments the disintegrant is an effervescent disintegrant. Non-limiting examples of suitable effervescent disintegrants include sodium bicarbonate in combination with citric acid, and sodium bicarbonate in combination with tartaric acid.

[407] In some embodiments, the composition (e.g., bacterial composition) is a food product (e.g., a food or beverage) such as a health food or beverage, a food or beverage for infants, a food or beverage for pregnant women, athletes, senior citizens or other specified group, a functional food, a beverage, a food or beverage for specified health use, a dietary supplement, a food or beverage for patients, or an animal feed. Specific examples of the foods and beverages include various beverages such as juices, refreshing beverages, tea beverages, drink preparations, jelly beverages, and functional beverages; alcoholic beverages such as beers; carbohydrate-containing foods such as rice food products, noodles, breads, and pastas; paste products such as fish hams, sausages, paste products of seafood; retort pouch products such as curries, food dressed with a thick starchy sauces, and Chinese soups; soups; dairy products such as milk, dairy beverages, ice creams, cheeses, and yogurts; fermented products such as fermented soybean pastes, yogurts, fermented beverages, and pickles; bean products; various confectionery products, including biscuits, cookies, and the like, candies, chewing gums, gummies, cold desserts including jellies, cream caramels, and frozen desserts; instant foods such as instant soups and instant soybean soups; microwavable foods; and the like. Further, the examples also include health foods and beverages prepared in the forms of powders, granules, tablets, capsules, liquids, pastes, and jellies.

[408] In some embodiments, the composition (e.g., bacterial composition) is a food product for animals, including humans. The animals, other than humans, are not particularly limited, and the composition can be used for various livestock, poultry, pets, experimental animals, and the like. Specific examples of the animals include pigs, cattle, horses, sheep, goats, chickens, wild ducks, ostriches, domestic ducks, dogs, cats, rabbits, hamsters, mice, rats, monkeys, and the like, but the animals are not limited thereto.

Dose Forms

[409] Dose forms comprising Prevotella histicola bacteria are also provided herein, e.g., for use in methods to treat or prevent inflammation (such as inflammation associated with psoriasis or atopic dermatitis or psoriatic arthritis) in a subject (e.g., a human subject). A bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola bacteria can be formulated as a solid dose form, e.g., for oral administration. In some embodiments, the bacterial composition (e.g., pharmaceutical composition) comprising Prevotella histicola bacteria is prepared as a powder (e.g., for resuspension or for use in a solid dose form (such as a capsule)) or as a solid dose form, such as a tablet, a mini-tablet, a capsule, or a powder; or a combination of these forms (e.g., mini-tablets comprised in a capsule)). The powder can comprise lyophilized bacteria. In some embodiments, the powder further comprises mannitol, magnesium stearate, and/or colloidal silicon dioxide. In some embodiments, the powder further comprises mannitol. In some embodiments, the powder further comprises magnesium stearate. In some embodiments, the powder further comprises colloidal silicon dioxide. In some embodiments, the Prevotella histicola bacteria are gamma irradiated.

[410] The solid dose form (also referred to as solid dosage form herein) can comprise one or more excipients, e.g., pharmaceutically acceptable excipients. The Prevotella histicola bacteria in the solid dose form can be isolated Prevotella histicola bacteria. Optionally, the Prevotella histicola bacteria in the solid dose form can be lyophilized. Optionally, the Prevotella histicola bacteria in the solid dose form are live. Optionally, the Prevotella histicola bacteria in the solid dose form are non-live. Optionally, the Prevotella histicola bacteria in the solid dose form are gamma irradiated. The solid dose form can comprise a tablet. The solid dose form can comprise a capsule. The solid dose form can comprise a tablet, a mini -tablet, a capsule, or a powder; or a combination of these forms (e.g., minitablets comprised in a capsule).

[411] The Prevotella histicola bacteria in the solid dose form can be in a powder (e.g., the powder comprises lyophilized Prevotella histicola bacteria). In some embodiments, the powder further comprises mannitol, magnesium stearate, and/or colloidal silicon dioxide. In some embodiments, the powder further comprises mannitol, magnesium stearate, and colloidal silicon dioxide. Optionally, the Prevotella histicola bacteria in the powder can be lyophilized. Optionally, the Prevotella histicola bacteria in the powder are live. Optionally, the Prevotella histicola bacteria in the solid dose form are non-live. Optionally, the Prevotella histicola bacteria in the powder are gamma irradiated.

[412] In some embodiments, the lyophilized Prevotella histicola bacteria (e.g., powder) is resuspended (e.g., in a liquid such as a solution, buffer, water or other beverage or a food), e.g., for administration to a subject.

[413] In some embodiments, the bacterial composition (e.g., pharmaceutical composition) provided herein is prepared as a solid dosage form comprising Prevotella histicola bacteria and a pharmaceutically acceptable carrier.

[414] In some embodiments, the bacterial composition (e.g., pharmaceutical composition) provided herein is prepared as a solid dosage form comprising Prevotella histicola bacteria and a pharmaceutically acceptable carrier. The solid dosage form can comprise a tablet, a mini-tablet, a capsule, a pill, or a powder; or a combination of these forms (e.g., minitablets comprised in a capsule).

[415] In some embodiments, the solid dosage form comprises a capsule. The capsule can comprise an enteric coating. The capsule can be a size 00, size 0, size 1, size 2, size 3, size 4, or size 5 capsule. In some embodiments, the capsule is a size 0 capsule.

[416] In some embodiments, the solid dosage form comprises a tablet (> 4mm) (e.g., 5mm-18mm). For example, the tablet is a 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm or 18mm tablet. In some embodiments, the tablet is a 17mm tablet. The size refers to the diameter of the tablet, as is known in the art.

[417] In some embodiments, the solid dosage form comprises a mini-tablet. The mini -tablet can be in the size range of lmm-4 mm range. E.g., the mini -tablet can be a 1mm mini-tablet, 1.5 mm mini-tablet, 2mm mini-tablet, 3mm mini-tablet, or 4mm mini-tablet. The size refers to the diameter of the mini-tablet, as is known in the art. As used herein, the size of the mini-tablet refers to the size of the mini-tablet prior to application of an enteric coating.

[418] As used herein, the size of the tablet refers to the size of the tablet, mini-tablet or capsule prior to application of an enteric coating.

[419] The mini-tablets can be in a capsule. The capsule can be a size 00, size 0, size 1, size 2, size 3, size 4, or size 5 capsule. The capsule that contains the mini -tablets can comprise a single layer coating, e.g., a non-enteric coating such as gelatin or HPMC. The mini -tablets can be inside a capsule: the number of mini-tablets inside a capsule will depend on the size of the capsule and the size of the mini-tablets. As an example, a size 0 capsule can contain 31-35 (an average of 33) mini-tablets that are 3mm mini-tablets.

Coating

[420] The solid dosage form (e.g., capsule, tablet or minitablet) described herein can be enterically coated, e.g., with one enteric coating layer or with two layers of enteric coating, e.g., an inner enteric coating and an outer enteric coating. The inner enteric coating and outer enteric coating are not identical (e.g., the inner enteric coating and outer enteric coating do not contain the same components in the same amounts). The enteric coating allows for release of the Prevotella histicola bacteria, e.g., in the small intestine.

[421] Release of the Prevotella histicola bacteria in the small intestine allows the pharmaceutical agent to target and affect cells (e.g., epithelial cells and/or immune cells) located at these specific locations, e.g., which can cause a local effect in the gastrointestinal tract and/or cause a systemic effect (e.g., an effect outside of the gastrointestinal tract).

[422] EUDRAGIT is the brand name for a diverse range of polymethacrylate- based copolymers. It includes anionic, cationic, and neutral copolymers based on methacrylic acid and methacrylic/acrylic esters or their derivatives.

[423] Examples of other materials that can be used in the enteric coating (e.g., the one enteric coating or the inner enteric coating and/or the outer enteric coating) include cellulose acetate phthalate (CAP), cellulose acetate trimellitate (CAT), poly(vinyl acetate phthalate) (PVAP), hydroxypropyl methylcellulose phthalate (HPMCP), fatty acids, waxes, shellac (esters of aleurtic acid), plastics, plant fibers, zein, Aqua-Zein® (an aqueous zein formulation containing no alcohol), amylose starch, starch derivatives, dextrins, methyl acrylate-methacrylic acid copolymers, cellulose acetate succinate, hydroxypropyl methyl cellulose acetate succinate (hypromellose acetate succinate), methyl methacrylatemethacrylic acid copolymers, and/or sodium alginate.

[424] The enteric coating (e.g., the one enteric coating or the inner enteric coating and/or the outer enteric coating) can include a methacrylic acid ethyl acrylate (MAE) copolymer (1 : 1).

[425] The one enteric coating can include methacrylic acid ethyl acrylate (MAE) copolymer (1 : 1) (such as Kollicoat MAE 100P).

[426] The one enteric coating can include a Eudragit copolymer, e.g., a Eudragit L (e.g., Eudragit L 100-55; Eudragit L 30 D-55), a Eudragit S, a Eudragit RL, a Eudragit RS, a Eudragit E, or a Eudragit FS (e.g., Eudragit FS 30 D).

[427] Other examples of materials that can be used in the enteric coating (e.g., the one enteric coating or the inner enteric coating and/or the outer enteric coating) include those described in, Hussan et al., IOSR Journal of Pharmacy volume 2, pages 5-11 (Nov- Dec 2012) and Hua, Frontiers in Pharmacology volume 11, article 524 (Apr 2020).

[428] Other examples of materials that can be used in the enteric coating (e.g., the one enteric coating or the inner enteric coating and/or the outer enteric coating) include those described in, e.g., U.S. 6312728; U.S. 6623759; U.S. 4775536; U.S. 5047258; U.S. 5292522; U.S. 6555124; U.S. 6638534; U.S. 2006/0210631; U.S. 2008/200482; U.S. 2005/0271778; U.S. 2004/0028737; WO 2005/044240.

[429] See also, e.g., U.S. 9233074, which provides pH dependent, enteric polymers that can be used with the solid dosage forms provided herein, including methacrylic acid copolymers, polyvinylacetate phthalate, hydroxypropylmethyl cellulose acetate succinate, hydroxypropylmethyl cellulose phthalate and cellulose acetate phthalate; suitable methacrylic acid copolymers include: poly(methacrylic acid, methyl methacrylate) 1 : 1 sold, for example, under the Eudragit L100 trade name; poly(methacrylic acid, ethyl acrylate) 1 : 1 sold, for example, under the Eudragit LI 00-55 trade name; partially- neutralized poly(methacrylic acid, ethyl acrylate) 1 : 1 sold, for example, under the Kollicoat MAE- 100P trade name; and poly(methacrylic acid, methyl methacrylate) 1 :2 sold, for example, under the Eudragit SI 00 trade name.

[430] In some embodiments, the solid dosage form comprises a sub-coat, e.g., under the enteric coating (e.g., one enteric coating). The sub-coat can be used, e.g., to visually mask the appearance of the Prevotella histicola bacteria.

[431] The coating level (also referred to herein as thickness) of the enteric coating on a solid dosage form influences the site of release of the Prevotella histicola bacteria from the solid dosage form after oral administration.

[432] In some embodiments, the enteric coating is at a coating level of between about 5 to about 31 mg per solid dose form (e.g., per capsule (e.g., size 0 capsule) or per tablet (e.g., 17 mm tablet)) (e.g., or an equivalent coating level for the given sized solid dose form). For example, if a size 0 capsule has a coating level of between about 5 to about 31 mg per capsule, a smaller capsule will have a coating level that is proportionate to about 5 to about 31 mg for its size.

[433] In some embodiments, the enteric coating is at a coating level of about 5 mg; about 9 mg; about 14 mg; about 19 mg; about 25 mg; or about 31 mg per solid dose form (e.g., per capsule (e.g., size 0 capsule) or per tablet (e.g., 17 mm tablet)) (e.g., or an equivalent coating level for the given sized solid dose form). For example, if a size 0 capsule has a coating level of about 5 mg, a smaller capsule will have a coating level that is proportionate to about 5 mg for its size.

[434] In some embodiments, the enteric coating is at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dose form (e.g., per capsule (e.g., between about 5 mg to about 31 mg per size 0 capsule)). In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² (e.g., about 5 mg per size 0 capsule); about 1.7 mg/cm² (e.g., about 9 mg per size 0 capsule); about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule); about 3.7 mg/cm² (e.g., about 19 mg per size 0 capsule); about 4.8 mg/cm² (e.g., about 25 mg per size 0 capsule); or about 6 mg/cm² (e.g., about 31 mg per size 0 capsule) per solid dose form (such as a capsule). In some embodiments, the enteric coating is at a coating level of about 1 mg/cm² per solid dose form (such as a capsule). In some embodiments, the enteric coating is at a coating level of about 1.7 mg/cm² per solid dose form (such as a capsule). In some embodiments, the enteric coating is at a coating level of about 2.7 mg/cm² per solid dose form (such as a capsule). In some embodiments, the enteric coating is at a coating level of about 3.7 mg/cm² per solid dose form (such as a capsule). In some embodiments, the enteric coating is at a coating level of about 4.8 mg/cm² per solid dose form (such as a capsule). In some embodiments, the enteric coating is at a coating level of about 6 mg/cm² per solid dose form (such as a capsule).

[435] In some embodiments, the enteric coating comprises a methacrylic acid ethyl acrylate (MAE) copolymer (1 :1). In some embodiments, the enteric coating comprises a methacrylic acid ethyl acrylate (MAE) copolymer (1 : 1) such as Eudragit L copolymer, such as Eudragit L 30 D-55. In some embodiments, the enteric coating comprises a methacrylic acid ethyl acrylate (MAE) copolymer (1 : 1) such as such as Kollicoat MAE 100P.

[436] In some embodiments, the enteric coating comprises a combination of two copolymers (e.g., a first copolymer and a second copolymer). In some embodiments, the combination of two copolymers comprises a combination of a methacrylic acid-ethyl acrylate copolymer (1 : 1) and a poly(methyl acrylate-co-methyl methacrylate-co- methacrylic acid) copolymer. In some embodiments, the combination of two copolymers comprises a combination of a Eudragit L copolymer and a Eudragit FS copolymer. In some embodiments, the combination of two copolymers comprises a combination of a methacrylic acid-ethyl acrylate copolymer (1 : 1) (such as Eudragit L copolymer, such as Eudragit L 30 D-55), and a poly(methyl acrylate-co-methyl methacrylate-co-methacrylic acid) copolymer (such as Eudragit FS copolymer, such as Eudragit FS 30 D). In some embodiments, the ratio of the first copolymer to the second copolymer is between about 100%:0% to about 0%: 100%. In some embodiments, the ratio of the first copolymer to the second copolymer is between about 75%:25% to about 25%:75%. In some embodiments, the ratio of the first copolymer to the second copolymer is about 100%:0; about 75%:25%; about 50%:50%; about 25%:75%; about 17.5%:82.5%; or about 0: 100%. In some embodiments, the first copolymer comprises a Eudragit L copolymer, such as Eudragit L 30 D-55 and the second copolymer comprises a Eudragit FS copolymer, such as Eudragit FS 30 D. Dosage

[437] In some embodiments, the bacterial composition, e.g., pharmaceutical composition (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 8 x IO¹⁰ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[438] In some embodiments, the bacterial composition, e.g., pharmaceutical composition (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about

[439] In some embodiments, the bacterial composition, e.g., pharmaceutical composition (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 3.2 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[440] In some embodiments, the bacterial composition, e.g., pharmaceutical composition (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 6.4 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[441] In some embodiments, the bacterial composition, e.g., pharmaceutical composition (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 8 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[442] In some embodiments, the bacterial composition, e.g., pharmaceutical composition (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about

9.6 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[443] In some embodiments, the bacterial composition, e.g., pharmaceutical composition (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 12.8 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[444] In some embodiments, the bacterial composition, e.g., pharmaceutical composition (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 16 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[445] In some embodiments, the bacterial composition, e.g., pharmaceutical composition (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about

9.6 x 10¹¹ to about 16 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[446] In some embodiments, the bacterial composition, e.g., pharmaceutical composition (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about

9.6 x 10¹¹ to about 12.8 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B

50329. [447] In some embodiments, the bacterial composition, e.g., pharmaceutical composition (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about

12.8 x 10¹¹ to about 16 x 10¹¹ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[448] In some embodiments, the bacterial composition, e.g., pharmaceutical composition (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 3.2 x IO¹⁰ to about 9.6 x IO¹⁰ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[449] In some embodiments, the bacterial composition, e.g., pharmaceutical composition (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about

4.8 x IO¹⁰ to about 9.6 x IO¹⁰ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[450] In some embodiments, the bacterial composition, e.g., pharmaceutical composition (e.g., composition of the total dose administered, e.g., once or twice daily) comprises about 6.4 x IO¹⁰ to about 9.6 x IO¹⁰ total cells of Prevotella histicola, e.g., of Prevotella Strain B 50329.

[451] In some embodiments, the dose of bacterial composition is administered as solid dosage form(s) comprising the Prevotella histicola bacteria. In some embodiments, the solid dosage form comprises an enteric coating. In some embodiments, the solid dosage form is a tablet, e.g., an enteric coated tablet. In some embodiments, the solid dosage form is a mini-tablet, e.g., an enteric coated mini-tablet. In some embodiments, the solid dosage form is a capsule, e.g., an enteric coated capsule.

[452] In some embodiments, a dose of Prevotella histicola bacteria of about 8 x 10¹⁰ total cells are administered (e.g., are for administration) per day.

[453] In some embodiments, a dose of Prevotella histicola bacteria of about 1.6 x 10¹¹ total cells are administered (e.g., are for administration) per day.

[454] In some embodiments, a dose of Prevotella histicola bacteria of about 3.2 x 10¹¹ total cells are administered (e.g., are for administration) per day.

[455] In some embodiments, a dose of Prevotella histicola bacteria of about 6.4 x 10¹¹ total cells are administered (e.g., are for administration) per day.

[456] In some embodiments, a dose of Prevotella histicola bacteria of about 8 x 10¹¹ total cells are administered (e.g., are for administration) per day. [457] In some embodiments, a dose of Prevotella histicola bacteria of about 9.6 x 10¹¹ total cells are administered (e.g., are for administration) per day.

[458] In some embodiments, a dose of Prevotella histicola bacteria of about 12.8 x 10¹¹ total cells are administered (e.g., are for administration) per day.

[459] In some embodiments, a dose of Prevotella histicola bacteria of about 16 x 10¹¹ total cells are administered (e.g., are for administration) per day.

[460] In some embodiments, the Prevotella histicola bacteria are quantified based on total cells, e.g., total cell count (TCC) (e.g., determined by Coulter counter).

Gamma-irradiation

[461] Powders (e.g., of Prevotella histicola bacteria) can be gamma-irradiated at 17.5 kGy radiation unit at ambient temperature.

[462] Frozen biomasses (e.g., of Prevotella histicola bacteria) can be gamma-irradiated at 25 kGy radiation unit in the presence of dry ice.

Methods of Use

[463] In some embodiments, bacterial compositions (e.g., prepared as solid dosage forms) described herein allow, e.g., for oral administration of Prevotella histicola bacteria contained therein.

[464] In some embodiments, bacterial compositions (e.g., prepared as solid dosage forms) described herein can be used in the treatment and/or prevention of inflammation, autoimmunity, a metabolic condition, or a dysbiosis.

[465] In some embodiments, bacterial compositions (e.g., prepared as solid dosage forms) described herein can be used in the treatment and/or prevention of bacterial septic shock, cytokine storm and/or viral infection (such as a coronavirus infection, an influenza infection, and/or a respiratory syncytial virus infection).

[466] In some embodiments, bacterial compositions (e.g., prepared as solid dosage forms) described herein can be used in the treatment and/or prevention of an inflammatory disease.

[467] In some embodiments, bacterial compositions (e.g., prepared as solid dosage forms) described herein can be used in the treatment and/or prevention of psoriasis.

[468] In some embodiments, bacterial compositions (e.g., prepared as solid dosage forms) described herein can be used in the treatment and/or prevention of atopic dermatitis. [469] In some embodiments, bacterial compositions (e.g., prepared as solid dosage forms) described herein can be used in the treatment and/or prevention of psoriatic arthritis.

[470] In some embodiments, bacterial compositions (e.g., prepared as solid dosage forms) described herein can be used in the treatment and/or prevention of an autoimmune disease.

[471] In some embodiments, bacterial compositions (e.g., prepared as solid dosage forms) described herein can be used in the treatment and/or prevention of a metabolic disease.

[472] In some embodiments, bacterial compositions (e.g., prepared as solid dosage forms) described herein can be used in the treatment and/or prevention of a dysbiosis.

[473] In some embodiments, bacterial compositions (e.g., prepared as solid dosage forms) described herein can be used to decrease inflammatory cytokine expression (e.g., decreased IL-8, IL-6, IL-ip, and/or TNFa expression levels).

[474] In some embodiments, bacterial compositions (e.g., prepared as solid dosage forms) described herein can be used to decrease IgE levels.

[475] In some embodiments, bacterial compositions (e.g., prepared as solid dosage forms) described herein can be used in the treatment and/or prevention of cytokine storm (cytokine release syndrome) in a subject in need thereof. In some embodiments, the cytokine storm is due to elevation in IL-8, IL-6, IL-ip, and/or TNFa expression levels.

[476] In some embodiments, bacterial compositions (e.g., prepared as solid dosage forms) described herein can be used in the treatment and/or prevention of bacterial septic shock.

[477] In some embodiments, bacterial compositions (e.g., prepared as solid dosage forms) described herein can be used in the treatment and/or prevention of a viral infection.

[478] Methods of using a bacterial composition (e.g., prepared as a solid dosage form) (e.g., for oral administration) (e.g., for pharmaceutical use) comprising bacteria (e.g., a therapeutically effective amount thereof), wherein the bacteria comprises Prevotella histicola bacteria, and wherein the bacterial composition (e.g., prepared as a solid dosage form) further comprises the disclosed components, are described herein.

[479] In some embodiments, methods and administered bacterial compositions (e.g., prepared as solid dosage forms)described herein allow, e.g., for oral administration of bacteria contained therein (e.g., a therapeutically effective amount thereof). The bacterial composition (e.g., prepared as a solid dosage form) can be administered to a subject is a fed or fasting state. The bacterial composition (e.g., prepared as a solid dosage form) can be administered, e.g., on an empty stomach (e.g., one hour before eating or two hours after eating). The bacterial composition (e.g., prepared as a solid dosage form) can be administered one hour before eating. The bacterial composition (e.g., prepared as a solid dosage form) can be administered two hours after eating. The bacterial composition (e.g., prepared as a solid dosage form) can be administered one hour before drinking (e.g., drinking an acidic drink). The bacterial composition (e.g., prepared as a solid dosage form) can be administered one hour after drinking (e.g., drinking an acidic drink).

[480] A bacterial composition (e.g., prepared as a solid dosage form) for use in the treatment and/or prevention of inflammation, autoimmunity, a metabolic condition, or a dysbiosis is provided herein.

[481] A bacterial composition (e.g., prepared as a solid dosage form) for use in the treatment and/or prevention of bacterial septic shock, cytokine storm and/or viral infection (such as a coronavirus infection, an influenza infection, and/or a respiratory syncytial virus infection) is provided herein.

[482] A bacterial composition (e.g., prepared as a solid dosage form) for use in decreasing inflammatory cytokine expression (e.g., decreased IL-8, IL-6, IL-ip, and/or TNFa expression levels) is provided herein.

[483] A bacterial composition (e.g., prepared as a solid dosage form) for use in decreasing inflammatory cytokine expression is provided herein. In some embodiments, the pro- inflammatory cytokine is IL-31, IL-23p40, IL-17, and/or IL-13. In some embodiments, the pro-inflammatory cytokine is IL-4, IL-5, and/or IL-13.

[484] A bacterial composition (e.g., prepared as a solid dosage form) for use in decreasing IgE levels is provided herein.

[485] Use of a bacterial composition (e.g., prepared as a solid dosage form) for the preparation of a medicament for the treatment and/or prevention of inflammation, autoimmunity, a metabolic condition, or a dysbiosis is provided herein.

[486] Use of a bacterial composition (e.g., prepared as a solid dosage form) for the preparation of a medicament for the treatment and/or prevention of bacterial septic shock, cytokine storm and/or viral infection (such as a coronavirus infection, an influenza infection, and/or a respiratory syncytial virus infection) is provided herein.

[487] Use of a bacterial composition (e.g., prepared as a solid dosage form) for the preparation of a medicament for decreasing inflammatory cytokine expression (e.g., decreased IL-8, IL-6, IL-ip, and/or TNFa expression levels) is provided herein.

[488] Use of a bacterial composition (e.g., prepared as a solid dosage form) for the preparation of a medicament for decreasing inflammatory cytokine expression is provided herein. In some embodiments, the pro-inflammatory cytokine is IL-31, IL-23p40, IL-17, and/or IL-13. In some embodiments, the pro-inflammatory cytokine is IL-4, IL-5, and/or IL-13.

[489] Use of a bacterial composition (e.g., prepared as a solid dosage form) for the preparation of a medicament for decreasing IgE levels is provided herein.

Additional Therapeutic

[490] In some aspects, the methods provided herein include the administration to a subject of a bacterial composition described herein either alone or in combination with an additional therapeutic. In some embodiments, the additional therapeutic is an immunosuppressant, or a steroid. In some embodiments, the additional therapeutic is a topical treatment. In some embodiments, the topical treatment comprises a topical corticosteroid (TCS), a topical calcineurin inhibitor (TCI) (Katoh, 2019), a topical Janus Kinase (JAK) or Phosphodiesterase 4 (PDE) inhibitor (Bieber, 2021).

[491] In some aspects, the methods provided herein include use of an emollient cream, gel or ointment. In some embodiments, a bland additive-free, sodium lauryl sulfate (SLS)-free, and fragrance-free emollient cream, gel or ointment is used. In some embodiments, the emollient cream, gel or ointment is used daily (e.g., twice daily) (or more, as needed) for at least 14 consecutive days immediately prior use of the Prevotella histicola bacteria. In some embodiments, the emollient cream, gel or ointment is used daily (e.g., twice daily) (or more, as needed) while the Prevotella histicola bacteria are used. In some embodiments, the emollient cream, gel or ointment is used daily (e.g., twice daily) (or more, as needed) for at least 14 consecutive days immediately prior use of the Prevotella histicola bacteria and is used daily (e.g., twice daily) (or more, as needed) while the Prevotella histicola bacteria are used.

[492] In some embodiments, the Prevotella histicola bacteria are administered to the subject before the additional therapeutic is administered (e.g., at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 or 24 hours before or at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29 or 30 days before). In some embodiments, the Prevotella histicola bacteria are administered to the subject after the additional therapeutic is administered (e.g., at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 or 24 hours after or at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29 or 30 days after). In some embodiments, the Prevotella histicola bacteria and the additional therapeutic are administered to the subject simultaneously or nearly simultaneously (e.g., administrations occur within an hour of each other). In some embodiments, the subject is administered an antibiotic before the Prevotella bacteria are administered to the subject (e.g., at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 or 24 hours before or at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20,

21, 22, 23, 24, 25, 26, 27, 28, 29 or 30 days before). In some embodiments, the subject is administered an antibiotic after the Prevotella bacteria are administered to the subject (e.g., at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 or 24 hours before or at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21,

22, 23, 24, 25, 26, 27, 28, 29 or 30 days after). In some embodiments, the Prevotella bacteria and the antibiotic are administered to the subject simultaneously or nearly simultaneously (e.g., administrations occur within an hour of each other).

[493] In some aspects, antibiotics can be selected based on their bactericidal or bacteriostatic properties. Bactericidal antibiotics include mechanisms of action that disrupt the cell wall (e.g., P-lactams), the cell membrane (e.g., daptomycin), or bacterial DNA (e.g., fluoroquinolones). Bacteriostatic agents inhibit bacterial replication and include sulfonamides, tetracyclines, and macrolides, and act by inhibiting protein synthesis. Furthermore, while some drugs can be bactericidal in certain organisms and bacteriostatic in others, knowing the target organism allows one skilled in the art to select an antibiotic with the appropriate properties. In certain treatment conditions, bacteriostatic antibiotics inhibit the activity of bactericidal antibiotics. Thus, in some embodiments, bactericidal and bacteriostatic antibiotics are not combined.

[494] Antibiotics include, but are not limited to aminoglycosides, ansamycins, carbacephems, carbapenems, cephalosporins, glycopeptides, lincosamides, lipopeptides, macrolides, monobactams, nitrofurans, oxazolidonones, penicillins, polypeptide antibiotics, quinolones, fluoroquinolone, sulfonamides, tetracyclines, and anti-mycobacterial compounds, and combinations thereof.

[495] Aminoglycosides include, but are not limited to Amikacin, Gentamicin, Kanamycin, Neomycin, Netilmicin, Tobramycin, Paromomycin, and Spectinomycin. Aminoglycosides are effective, e.g., against Gram -negative bacteria, such as Escherichia coh. Klebsiella, Pseudomonas aeruginosa, and Francisella tularensis, and against certain aerobic bacteria but less effective against obligate/facultative anaerobes. Aminoglycosides are believed to bind to the bacterial 30S or 50S ribosomal subunit thereby inhibiting bacterial protein synthesis.

[496] Ansamycins include, but are not limited to, Geldanamycin, Herbimycin, Rifamycin, and Streptovaricin. Geldanamycin and Herbimycin are believed to inhibit or alter the function of Heat Shock Protein 90.

[497] Carbacephems include, but are not limited to, Loracarbef. Carbacephems are believed to inhibit bacterial cell wall synthesis.

[498] Carbapenems include, but are not limited to, Ertapenem, Doripenem, Imipenem/Cilastatin, and Meropenem. Carbapenems are bactericidal for both Grampositive and Gram-negative bacteria as broad-spectrum antibiotics. Carbapenems are believed to inhibit bacterial cell wall synthesis.

[499] Cephalosporins include, but are not limited to, Cefadroxil, Cefazolin, Cefalotin, Cefalothin, Cefalexin, Cefaclor, Cefamandole, Cefoxitin, Cefprozil, Cefuroxime, Cefixime, Cefdinir, Cefditoren, Cefoperazone, Cefotaxime, Cefpodoxime, Ceftazidime, Ceftibuten, Ceftizoxime, Ceftriaxone, Cefepime, Ceftaroline fosamil, and Ceftobiprole. Selected Cephalosporins are effective, e.g., against Gram-negative bacteria and against Grampositive bacteria, including Pseudomonas, certain Cephalosporins are effective against methicillin-resistant Staphylococcus aureus (MRSA). Cephalosporins are believed to inhibit bacterial cell wall synthesis by disrupting synthesis of the peptidoglycan layer of bacterial cell walls.

[500] Glycopeptides include, but are not limited to, Teicoplanin, Vancomycin, and Telavancin. Glycopeptides are effective, e.g., against aerobic and anaerobic Gram-positive bacteria including MRSA and Clostridium difficile. Glycopeptides are believed to inhibit bacterial cell wall synthesis by disrupting synthesis of the peptidoglycan layer of bacterial cell walls.

[501] Lincosamides include, but are not limited to, Clindamycin and Lincomycin. Lincosamides are effective, e.g., against anaerobic bacteria, as well as Staphylococcus and Streptococcus. Lincosamides are believed to bind to the bacterial 50S ribosomal subunit thereby inhibiting bacterial protein synthesis.

[502] Lipopeptides include, but are not limited to, Daptomycin. Lipopeptides are effective, e.g., against Gram -positive bacteria. Lipopeptides are believed to bind to the bacterial membrane and cause rapid depolarization. [503] Macrolides include, but are not limited to, Azithromycin, Clarithromycin, Dirithromycin, Erythromycin, Roxithromycin, Troleandomycin, Telithromycin, and Spiramycin. Macrolides are effective, e.g., against Streptococcus and My coplasma. Macrolides are believed to bind to the bacterial or 50S ribosomal subunit, thereby inhibiting bacterial protein synthesis.

[504] Monobactams include, but are not limited to, Aztreonam. Monobactams are effective, e.g., against Gram-negative bacteria. Monobactams are believed to inhibit bacterial cell wall synthesis by disrupting synthesis of the peptidoglycan layer of bacterial cell walls.

[505] Nitrofurans include, but are not limited to, Furazolidone and Nitrofurantoin.

[506] Oxazolidonones include, but are not limited to, Linezolid, Posizolid, Radezolid, and Torezolid. Oxazolidonones are believed to be protein synthesis inhibitors.

[507] Penicillins include, but are not limited to, Amoxicillin, Ampicillin, Azlocillin, Carbenicillin, Cioxacillin, Dicloxacillin, Flucioxacillin, Mezlocillin, Methicillin, Nafcillin, Oxacillin, Penicillin G, Penicillin V, Piperacillin, Temocillin and Ticarcillin. Penicillins are effective, e.g., against Gram-positive bacteria, facultative anaerobes, e.g., Streptococcus, Borrelia, and Treponema. Penicillins are believed to inhibit bacterial cell wall synthesis by disrupting synthesis of the peptidoglycan layer of bacterial cell walls.

[508] Penicillin combinations include, but are not limited to, Amoxicillin/clavulanate, Ampicillin/sulbactam, Piperacillin/tazobactam, and Ticarcillin/clavulanate.

[509] Polypeptide antibiotics include, but are not limited to, Bacitracin, Colistin, and Polymyxin B and E. Polypeptide Antibiotics are effective, e.g., against Gram -negative bacteria. Certain polypeptide antibiotics are believed to inhibit isoprenyl pyrophosphate involved in synthesis of the peptidoglycan layer of bacterial cell walls, while others destabilize the bacterial outer membrane by displacing bacterial counter-ions.

[510] Quinolones and Fluoroquinolone include, but are not limited to, Ciprofloxacin, Enoxacin, Gatifloxacin, Gemifloxacin, Levofloxacin, Lomefloxacin, Moxifloxacin, Nalidixic acid, Norfloxacin, Ofloxacin, Trovafloxacin, Grepafloxacin, Sparfloxacin, and Temafloxacin. Quinolones/Fluoroquinolone are effective, e.g., against Streptococcus and Neisseria. Quinolones/Fluoroquinolone are believed to inhibit the bacterial DNA gyrase or topoisomerase IV, thereby inhibiting DNA replication and transcription.

[511] Sulfonamides include, but are not limited to, Mafenide, Sulfacetamide, Sulfadiazine, Silver sulfadiazine, Sulfadimethoxine, Sulfamethizole, Sulfamethoxazole, Sulfanilimide, Sulfasalazine, Sulfisoxazole, Trimethoprim-Sulfamethoxazole (Co-trimoxazole), and Sulfonamidochrysoidine. Sulfonamides are believed to inhibit folate synthesis by competitive inhibition of dihydropteroate synthetase, thereby inhibiting nucleic acid synthesis.

[512] Tetracyclines include, but are not limited to, Demeclocycline, Doxycycline, Minocycline, Oxytetracycline, and Tetracycline. Tetracyclines are effective, e.g., against Gram-negative bacteria. Tetracyclines are believed to bind to the bacterial 30S ribosomal subunit thereby inhibiting bacterial protein synthesis.

[513] Anti-mycobacterial compounds include, but are not limited to, Clofazimine, Dapsone, Capreomycin, Cycloserine, Ethambutol, Ethionamide, Isoniazid, Pyrazinamide, Rifampicin, Rifabutin, Rifapentine, and Streptomycin.

[514] Suitable antibiotics also include arsphenamine, chloramphenicol, fosfomycin, fusidic acid, metronidazole, mupirocin, platensimycin, quinupristin/dalfopristin, tigecycline, tinidazole, trimethoprim amoxicillin/clavulanate, ampicillin/sulbactam, amphomycin ristocetin, azithromycin, bacitracin, buforin II, carbomycin, cecropin Pl, clarithromycin, erythromycins, furazolidone, fusidic acid, Na fusidate, gramicidin, imipenem, indolicidin, josamycin, magainan II, metronidazole, nitroimidazoles, mikamycin, mutacin B-Ny266, mutacin B-JH1 140, mutacin J-T8, nisin, nisin A, novobiocin, oleandomycin, ostreogrycin, piperacillin/tazobactam, pristinamycin, ramoplanin, ranalexin, reuterin, rifaximin, rosamicin, rosaramicin, spectinomycin, spiramycin, staphylomycin, streptogramin, streptogramin A, synergistin, taurolidine, teicoplanin, telithromycin, ticarcillin/clavulanic acid, triacetyloleandomycin, tylosin, tyrocidin, tyrothricin, vancomycin, vemamycin, and virginiamycin.

[515] In some embodiments, the additional therapeutic is an immunosuppressive agent, a DMARD, a pain-control drug, a steroid, a non-steroidal anti-inflammatory drug (NS AID), or a cytokine antagonist, and combinations thereof. Representative agents include, but are not limited to, cyclosporin, retinoids, corticosteroids, propionic acid derivative, acetic acid derivative, enolic acid derivatives, fenamic acid derivatives, Cox-2 inhibitors, lumiracoxib, ibuprophen, cholin magnesium salicylate, fenoprofen, salsalate, difunisal, tolmetin, ketoprofen, flurbiprofen, oxaprozin, indomethacin, sulindac, etodolac, ketorolac, nabumetone, naproxen, valdecoxib, etoricoxib, MK0966; rofecoxib, acetominophen, Celecoxib, Diclofenac, tramadol, piroxicam, meloxicam, tenoxicam, droxicam, lomoxicam, isoxicam, mefanamic acid, meclofenamic acid, flufenamic acid, tolfenamic, valdecoxib, parecoxib, etodolac, indomethacin, aspirin, ibuprophen, firocoxib, methotrexate (MTX), antimalarial drugs (e.g., hydroxychloroquine and chloroquine), sulfasalazine, Leflunomide, azathioprine, cyclosporin, gold salts, minocycline, cyclophosphamide, D-penicillamine, minocycline, auranofin, tacrolimus, myocrisin, chlorambucil, TNF alpha antagonists (e.g., TNF alpha antagonists or TNF alpha receptor antagonists), e.g., ADALIMUMAB (Humira®), ETANERCEPT (Enbrel®), INFLIXIMAB (Remicade®; TA-650), CERTOLIZUMAB PEGOL (Cimzia®; CDP870), GOLIMUMAB (Simpom®; CNTO 148), ANAKINRA (Kineret®), RITUXIMAB (Rituxan®; MabThera®), AB AT ACEPT (Orencia®), TOCILIZUMAB (RoActemra /Actemra®), integrin antagonists (TYSABRI® (natalizumab)), IL-1 antagonists (ACZ885 (Haris)), Anakinra (Kineret®)), CD4 antagonists, IL-23 antagonists, IL-20 antagonists, IL-6 antagonists, BLyS antagonists (e.g., Atacicept, Benlysta®/ LymphoStat-B® (belimumab)), p38 Inhibitors, CD20 antagonists (Ocrelizumab, Ofatumumab (Arzerra®)), interferon gamma antagonists (Fontolizumab), prednisolone, Prednisone, dexamethasone, Cortisol, cortisone, hydrocortisone, methylprednisolone, betamethasone, triamcinolone, beclometasome, fludrocortisone, deoxycorticosterone, aldosterone, Doxycycline, vancomycin, pioglitazone, SBI-087, SCIO- 469, Cura- 100, Oncoxin + Viusid, TwHF, Methoxsalen, Vitamin D - ergocalciferol, Milnacipran, Paclitaxel, rosig tazone, Tacrolimus (Prograf®), RADOO1, rapamune, rapamycin, fostamatinib, Fentanyl, XOMA 052, Fostamatinib disodium, rosightazone, Curcumin (Longvida™), Rosuvastatin, Maraviroc, ramipnl, Milnacipran, Cobiprostone, somatropin, tgAAC94 gene therapy vector, MK0359, GW856553, esomeprazole, everolimus, trastuzumab, JAK1 and JAK2 inhibitors, pan JAK inhibitors, e.g., tetracyclic pyridone 6 (P6), 325, PF-956980, denosumab, IL-6 antagonists, CD20 antagonistis, CTLA4 antagonists, IL-8 antagonists, IL-21 antagonists, IL-22 antagonist, integrin antagonists (Tysarbri® (natalizumab)), VGEF antagnosits, CXCL antagonists, MMP antagonists, defensin antagonists, IL-1 antagonists (including IL-1 beta antagonsits), and IL-23 antagonists (e.g., receptor decoys, antagonistic antibodies, etc.).

[516] In some embodiments, the additional therapeutic is an oral PDE4 inhibitor (such as apremilast).

[517] In some embodiments, the additional therapeutic is apremilast, etanercept, infliximab, adalimumab, ustekinumab, dupilumab, or secukinumab.

[518] In some embodiments, the additional therapeutic is an immunosuppressive agent. Examples of immunosuppressive agents include, but are not limited to, corticosteroids, mesalazine, mesalamine, sulfasalazine, sulfasalazine derivatives, immunosuppressive drugs, cyclosporin A, mercaptopurine, azathiopurine, prednisone, methotrexate, antihistamines, glucocorticoids, epinephrine, theophylline, cromolyn sodium, antileukotrienes, anti-cholinergic drugs for rhinitis, TLR antagonists, inflammasome inhibitors, anti-cholinergic decongestants, mast-cell stabilizers, monoclonal anti-IgE antibodies, vaccines (e.g., vaccines used for vaccination where the amount of an allergen is gradually increased), cytokine inhibitors, such as anti-IL-6 antibodies, TNF inhibitors such as infliximab, adalimumab, certolizumab pegol, golimumab, or etanercept, and combinations thereof.

[519] In some embodiments, the additional therapeutic is an oral or injectable corticosteroid, methotrexate, azathioprine, cyclosporine, mycophenolate mofetil, a JAK inhibitor, tacrolimus, and/or leukotriene inhibitor.

[520] In some embodiments, the additional therapeutic is a topical corticosteroid, a topical calcineurin inhibitor (e.g., tacrolimus or pimecrolimus), or a topical PDE-4 inhibitor (e.g., crisaborole).

Administration

[521] In some embodiments, the bacterial composition is administered orally. In some embodiments, the administration to the subject once daily. In some embodiments, the administration to the subject twice daily. In some embodiments, the bacterial composition is administered in 2 or more doses (e.g., 3 or more, 4 or more or 5 or more doses). In some embodiments, the administration to the subject of the two or more doses are separated by at least 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, 12 hours, 13 hours, 14 hours, 15 hours, 16 hours, 17 hours, 18 hours, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, 10 days, 11 days, 12 days, 13 days, 14 days, 15 days, 16 days, 17 days, 18 days, 19 days, 20 days or 21 days.

[522] In some embodiments, the bacterial composition is administered once daily. In some embodiments, the bacterial composition is administered once daily for at least 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. In some embodiments, the bacterial composition is administered once daily for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks.

[523] In some embodiments, the bacterial composition is administered twice daily. In some embodiments, the bacterial composition is administered twice daily for at least 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. In some embodiments, the bacterial composition is administered twice daily for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks.

[524] In some embodiments, the bacterial composition is formulated as a tablet. In some embodiments, the bacterial composition is formulated as a capsule. In some embodiments, the bacterial composition comprises an enteric coating or micro encapsulation.

[525] In some embodiments, the subject is a mammal. In some embodiments, the subject is a human. In some embodiments, the subject is a non-human mammal (e.g., a dog, a cat, a cow, a horse, a pig, a donkey, a goat, a camel, a mouse, a rat, a guinea pig, a sheep, a llama, a monkey, a gorilla, or a chimpanzee).

[526] In some embodiments of the methods provided herein, the bacterial composition is administered in conjunction with the administration of an additional therapeutic. In some embodiments, the bacterial composition comprises Prevotella bacteria co-formulated with the additional therapeutic. In some embodiments, the bacterial composition is coadministered with the additional therapeutic. In some embodiments, the additional therapeutic is administered to the subject before administration of the bacterial composition (e.g., about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50 or 55 minutes before, about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22 or 23 hours before, or about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 or 14 days before). In some embodiments, the additional therapeutic is administered to the subject after administration of the bacterial composition (e.g., about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50 or 55 minutes after, about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22 or 23 hours after, or about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 or 14 days after). In some embodiments, the same mode of delivery is used to deliver both the bacterial composition and the additional therapeutic. In some embodiments, different modes of delivery are used to administer the bacterial composition and the additional therapeutic. For example, in some embodiments, the bacterial composition is administered orally while the additional therapeutic is administered via injection (e.g., an intravenous, and/or intramuscular injection). As another example, in some embodiments, the bacterial composition is administered orally while the additional therapeutic is administered topically.

[527] In some embodiments, bacterial compositions and dosage forms (e.g., solid dosage forms described herein can be administered in conjunction with any other conventional treatment. These treatments may be applied as necessary and/or as indicated and may occur before, concurrent with or after administration of the bacterial compositions anddosage forms described herein.

[528] The dosage regimen can be any of a variety of methods and amounts, and can be determined by one skilled in the art according to known clinical factors. As is known in the medical arts, dosages for any one patient can depend on many factors, including the subject's species, size, body surface area, age, sex, immunocompetence, and general health, the therapeuticto be administered, duration and route of administration, the kind and stage of the disease, and other compounds such as an additional therapeutic being administered concurrently. In addition to the above factors, such levels can be affected by the infectivity of the microorganism, and the nature of the microorganism, as can be determined by one skilled in the art. In the present methods, appropriate minimum dosage levels of microorganisms can be levels sufficient for the microorganism to survive, grow and replicate. The dose of the bacterial compositions described herein may be appropriately set or adjusted in accordance with the dosage form, the route of administration, the degree or stage of a target disease, and the like.

[529] In some embodiments, the dose administered to a subject is sufficient to prevent disease (e.g., autoimmune disease, inflammatory disease, metabolic disease), or treat disease, e.g., delay its onset, ameliorate one or more symptom of the disease, lessen the severity of the disease (or a symptom thereof), or slow or stop its progression. One skilled in the art will recognize that dosage will depend upon a variety of factors including the strength of the particular compound employed, as well as the age, species, condition, and body weight of the subject. The size of the dose will also be determined by the route, timing, and frequency of administration as well as the existence, nature, and extent of any adverse side-effects that might accompany the administration of a particular compound and the desired physiological effect.

[530] In accordance with the above, in therapeutic applications (e.g., for treatment and/or prevention), the dosages of the additional therapeutic used in accordance with the methods disclosed herein vary depending on the active agent, the age, weight, and clinical condition of the recipient patient, and the experience and judgment of the clinician or practitioner administering the therapy, among other factors affecting the selected dosage.

[531] Separate administrations can include any number of two or more administrations, including two, three, four, five or six administrations. One skilled in the art can readily determine the number of administrations to perform or the desirability of performing one or more additional administrations according to methods known in the art for monitoring therapeutic methods and other monitoring methods provided herein. Accordingly, the methods provided herein include methods of providing to the subject one or more administrations of an additional therapeutic, where the number of administrations can be determined by monitoring the subject, and, based on the results of the monitoring, determining whether or not to provide one or more additional administrations. Deciding on whether or not to provide one or more additional administrations can be based on a variety of monitoring results.

[532] The time period between administrations can be any of a variety of time periods. The time period between administrations can be a function of any of a variety of factors, including monitoring steps, as described in relation to the number of administrations, the time period for a subject to mount an immune response and/or the time period for a subject to clear the bacteria from normal tissue. In one example, the time period can be a function of the time period for a subject to mount an immune response; for example, the time period can be more than the time period for a subject to mount an immune response, such as more than about one week, more than about ten days, more than about two weeks, or more than about a month; in another example, the time period can be less than the time period for a subject to mount an immune response, such as less than about one week, less than about ten days, less than about two weeks, or less than about a month.

[533] In some embodiments, the delivery of an additional therapeutic in combination with the bacterial composition described herein reduces the adverse effects and/or improves the efficacy of the additional therapeutic.

[534] The effective dose of an additional therapeutic described herein is the amount of the additional therapeutic that is effective to achieve the desired therapeutic response for a particular patient, composition, and mode of administration, with the least toxicity to the patient. The effective dosage level can be identified using the methods described herein and will depend upon a variety of pharmacokinetic factors including the activity of the particular compositions administered, the route of administration, the time of administration, the rate of excretion of the particular compound being employed, the duration of the treatment, other drugs, compounds and/or materials used in combination with the particular compositions employed, the age, sex, weight, condition, general health and prior medical history of the patient being treated, and like factors well known in the medical arts. In general, an effective dose of an additional therapeutic will be the amount of the additional therapeutic which is the lowest dose effective to produce a therapeutic effect. Such an effective dose will generally depend upon the factors described above.

[535] The toxicity of an additional therapeutic is the level of adverse effects experienced by the subject during and following treatment. Adverse events associated with an additional therapeutic toxicity include, but are not limited to, abdominal pain, acid indigestion, acid reflux, allergic reactions, alopecia, anaphylaxis, anemia, anxiety, lack of appetite, arthralgias, asthenia, ataxia, azotemia, loss of balance, bone pain, bleeding, blood clots, low blood pressure, elevated blood pressure, difficulty breathing, bronchitis, bruising, low white blood cell count, low red blood cell count, low platelet count, cardiotoxicity, cystitis, hemorrhagic cystitis, arrhythmias, heart valve disease, cardiomyopathy, coronary artery disease, cataracts, central neurotoxicity, cognitive impairment, confusion, conjunctivitis, constipation, coughing, cramping, cystitis, deep vein thrombosis, dehydration, depression, diarrhea, dizziness, dry mouth, dry skin, dyspepsia, dyspnea, edema, electrolyte imbalance, esophagitis, fatigue, loss of fertility, fever, flatulence, flushing, gastric reflux, gastroesophageal reflux disease, genital pain, granulocytopenia, gynecomastia, glaucoma, hair loss, hand-foot syndrome, headache, hearing loss, heart failure, heart palpitations, heartburn, hematoma, hemorrhagic cystitis, hepatotoxicity, hyperamylasemia, hypercalcemia, hyperchloremia, hyperglycemia, hyperkalemia, hyperlipasemia, hypermagnesemia, hypernatremia, hyperphosphatemia, hyperpigmentation, hypertriglyceridemia, hyperuricemia, hypoalbuminemia, hypocalcemia, hypochloremia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia, impotence, infection, injection site reactions, insomnia, iron deficiency, itching, joint pain, kidney failure, leukopenia, liver dysfunction, memory loss, menopause, mouth sores, mucositis, muscle pain, myalgias, myelosuppression, myocarditis, neutropenic fever, nausea, nephrotoxicity, neutropenia, nosebleeds, numbness, ototoxicity, pain, palmar- plantar erythrodysesthesia, pancytopenia, pericarditis, peripheral neuropathy, pharyngitis, photophobia, photosensitivity, pneumonia, pneumonitis, proteinuria, pulmonary embolus, pulmonary fibrosis, pulmonary toxicity, rash, rapid heartbeat, rectal bleeding, restlessness, rhinitis, seizures, shortness of breath, sinusitis, thrombocytopenia, tinnitus, urinary tract infection, vaginal bleeding, vaginal dryness, vertigo, water retention, weakness, weight loss, weight gain, and xerostomia. In general, toxicity is acceptable if the benefits to the subject achieved through the therapy outweigh the adverse events experienced by the subject due to the therapy. Immune disorders

[536] In some embodiments, the methods and compositions described herein relate to the treatment or prevention of a disease or disorder associated a pathological immune response, such as an autoimmune disease, an allergic reaction and/or an inflammatory disease. In some embodiments, the disease or disorder is an inflammatory bowel disease (e.g., Crohn’s disease or ulcerative colitis). In some embodiments, the disease or disorder is psoriasis (e.g., mild to moderate psoriasis). In some embodiments, the disease or disorder is atopic dermatitis (e.g., mild to moderate atopic dermatitis). In some embodiments, the disease or disorder is psoriatic arthritis.

[537] The methods described herein can be used to treat any subject in need thereof. As used herein, a “subject in need thereof’ includes any subject that has a disease or disorder associated with a pathological immune response (psoriasis (e.g., mild to moderate psoriasis) or atopic dermatitis (e.g., mild to moderate atopic dermatitis)) or psoriatic arthritis, as well as any subject with an increased likelihood of acquiring a such a disease or disorder.

[538] The compositions described herein can be used, for example, as a bacterial composition for preventing or treating (reducing, partially or completely, the adverse effects of) an autoimmune disease, such as chronic inflammatory bowel disease, systemic lupus erythematosus, psoriasis, psoriatic arthritis, muckle-wells syndrome, rheumatoid arthritis, multiple sclerosis, or Hashimoto's disease; an allergic disease, such as a food allergy, pollenosis, or asthma; an infectious disease, such as an infection with Clostridium difficile^ an inflammatory disease such as a TNF-mediated inflammatory disease (e.g., an inflammatory disease of the gastrointestinal tract, such as pouchitis, a cardiovascular inflammatory condition, such as atherosclerosis, or an inflammatory lung disease, such as chronic obstructive pulmonary disease); a bacterial composition for suppressing rejection in organ transplantation or other situations in which tissue rejection might occur; a supplement, food, or beverage for improving immune functions; or a reagent for suppressing the proliferation or function of immune cells.

[539] In some embodiments, the methods and compositions provided herein are useful for the treatment of inflammation (such as Thl, Th2 and/or Thl7 inflammation). In some embodiments, the inflammation of any tissue and organs of the body, including musculoskeletal inflammation, vascular inflammation, neural inflammation, digestive system inflammation, ocular inflammation, inflammation of the reproductive system, and other inflammation, as discussed below.

[540] Immune disorders of the musculoskeletal system include, but are not limited, to those conditions affecting skeletal joints, including joints of the hand, wrist, elbow, shoulder, jaw, spine, neck, hip, knew, ankle, and foot, and conditions affecting tissues connecting muscles to bones such as tendons. Examples of such immune disorders, which may be treated with the methods and compositions described herein include, but are not limited to, arthritis (including, for example, osteoarthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, acute and chronic infectious arthritis, arthritis associated with gout and pseudogout, and juvenile idiopathic arthritis), tendonitis, synovitis, tenosynovitis, bursitis, fibrositis (fibromyalgia), epicondylitis, myositis, and osteitis (including, for example, Paget's disease, osteitis pubis, and osteitis fibrosa cystic).

[541] Ocular immune disorders refer to an immune disorder that affects any structure of the eye, including the eye lids. Examples of ocular immune disorders which may be treated with the methods and compositions described herein include, but are not limited to, blepharitis, blepharochalasis, conjunctivitis, dacryoadenitis, keratitis, keratoconjunctivitis sicca (dry eye), scleritis, trichiasis, and uveitis.

[542] Examples of nervous system immune disorders which may be treated with the methods and compositions described herein include, but are not limited to, encephalitis, Guillain-Barre syndrome, meningitis, neuromyotonia, narcolepsy, multiple sclerosis, myelitis and schizophrenia. Examples of inflammation of the vasculature or lymphatic system which may be treated with the methods and compositions described herein include, but are not limited to, arthrosclerosis, arthritis, phlebitis, vasculitis, and lymphangitis.

[543] Examples of digestive system immune disorders which may be treated with the methods and compositions described herein include, but are not limited to, cholangitis, cholecystitis, enteritis, enterocolitis, gastritis, gastroenteritis, inflammatory bowel disease, ileitis, and proctitis. Inflammatory bowel diseases include, for example, certain art- recognized forms of a group of related conditions. Several major forms of inflammatory bowel diseases are known, with Crohn's disease (regional bowel disease, e.g., inactive and active forms) and ulcerative colitis (e.g., inactive and active forms) the most common of these disorders. In addition, the inflammatory bowel disease encompasses irritable bowel syndrome, microscopic colitis, lymphocytic-plasmocytic enteritis, coeliac disease, collagenous colitis, lymphocytic colitis and eosinophilic enterocolitis. Other less common

I l l forms of IBD include indeterminate colitis, pseudomembranous colitis (necrotizing colitis), ischemic inflammatory bowel disease, Behcet’s disease, sarcoidosis, scleroderma, IBD- associated dysplasia, dysplasia associated masses or lesions, and primary sclerosing cholangitis.

[544] Examples of reproductive system immune disorders which may be treated with the methods and compositions described herein include, but are not limited to, cervicitis, chorioamnionitis, endometritis, epididymitis, omphalitis, oophoritis, orchitis, salpingitis, tubo-ovarian abscess, urethritis, vaginitis, vulvitis, and vulvodynia.

[545] The methods and compositions described herein may be used to treat autoimmune conditions having an inflammatory component. Such conditions include, but are not limited to, acute disseminated alopecia universalise, Behcet's disease, Chagas disease, chronic fatigue syndrome, dysautonomia, encephalomyelitis, ankylosing spondylitis, aplastic anemia, hidradenitis suppurativa, autoimmune hepatitis, autoimmune oophoritis, celiac disease, Crohn's disease, diabetes mellitus type 1, giant cell arteritis, Goodpasture syndrome, Grave's disease, Guillain-Barre syndrome, Hashimoto's disease, Henoch- Schonlein purpura, Kawasaki's disease, lupus erythematosus, microscopic colitis, microscopic polyarteritis, mixed connective tissue disease, Muckle-Wells syndrome, multiple sclerosis, myasthenia gravis, opsoclonus myoclonus syndrome, optic neuritis, Ord’s thyroiditis, pemphigus, polyarteritis nodosa, polymyalgia, rheumatoid arthritis, Reiter's syndrome, Sjogren's syndrome, temporal arteritis, Wegener's granulomatosis, warm autoimmune haemolytic anemia, interstitial cystitis, Lyme disease, morphea, psoriasis, psoriatic arthritis, sarcoidosis, scleroderma, ulcerative colitis, and vitiligo.

[546] The methods and compositions described herein may be used to treat T-cell mediated hypersensitivity diseases having an inflammatory component. Such conditions include, but are not limited to, contact hypersensitivity, contact dermatitis (including that due to poison ivy), uticaria, skin allergies, respiratory allergies (hay fever, allergic rhinitis, house dust mite allergy) and gluten-sensitive enteropathy (celiac disease).

[547] Other immune disorders which may be treated with the methods and compositions include, for example, appendicitis, dermatitis, dermatomyositis, endocarditis, fibrositis, gingivitis, glossitis, hepatitis, hidradenitis suppurativa, iritis, laryngitis, mastitis, myocarditis, nephritis, otitis, pancreatitis, parotitis, pericarditis, peritonitis, pharyngitis, pleuritis, pneumonitis, prostatitis, pyelonephritis, and stomatitis, transplant rejection (involving organs such as kidney, liver, heart, lung, pancreas (e.g., islet cells), bone marrow, cornea, small bowel, skin allografts, skin homografts, and heart valve xenografts, serum sickness, and graft vs host disease), acute pancreatitis, chronic pancreatitis, acute respiratory distress syndrome, Sexary's syndrome, congenital adrenal hyperplasis, nonsuppurative thyroiditis, hypercalcemia associated with cancer, pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme, exfoliative dermatitis, seborrheic dermatitis, seasonal or perennial allergic rhinitis, bronchial asthma, contact dermatitis, atopic dermatitis, drug hypersensitivity reactions, allergic conjunctivitis, keratitis, herpes zoster ophthalmicus, iritis and oiridocyclitis, chorioretinitis, optic neuritis, symptomatic sarcoidosis, fulminating or disseminated pulmonary tuberculosis chemotherapy, idiopathic thrombocytopenic purpura in adults, secondary thrombocytopenia in adults, acquired (autoimmune) haemolytic anemia, leukaemia and lymphomas in adults, acute leukaemia of childhood, regional enteritis, autoimmune vasculitis, multiple sclerosis, chronic obstructive pulmonary disease, solid organ transplant rejection, sepsis. Exemplary treatments include treatment of transplant rejection, rheumatoid arthritis, psoriatic arthritis, multiple sclerosis, Type 1 diabetes, asthma, inflammatory bowel disease, systemic lupus erythematosis, psoriasis, psoriatic arthritis, chronic obstructive pulmonary disease, and inflammation accompanying infectious conditions (e.g., sepsis).

[548] In some aspects, bacterial compositions for use of treating psoriasis (e.g., mild, moderate, or severe psoriasis or mild to moderate psoriasis) are disclosed.

[549] In some aspects, a bacterial composition comprising revote/Za histicola, wherein the Prevotella histicola is a strain comprising at least 85% sequence identity to the nucleotide sequence of the Prevotella histicola Strain B 50329 (NRRL accession number B 50329) for use in treating psoriasis is described herein.

[550] In some aspects, uses of a bacterial composition for the preparation of a medicament for treating psoriasis (e.g., mild, moderate, or severe psoriasis or mild to moderate psoriasis) are disclosed.

[551] In some aspects, use of a bacterial composition for the preparation of a medicament for treating psoriasis wherein the bacterial composition comprises Prevotella histicola, wherein the Prevotella histicola is a strain comprising at least 85% sequence identity to the nucleotide sequence of the Prevotella histicola Strain B 50329 (NRRL accession number B 50329) is described herein. In some embodiments, the psoriasis is mild, moderate, or severe psoriasis. In some embodiments, the psoriasis is mild to moderate psoriasis. [552] In some aspects, bacterial compositions for use of treating psoriatic arthritis (e.g., mild to moderate psoriatic arthritis, or mild, moderate, or severe psoriatic arthritis) are disclosed. In some aspects, a bacterial composition comprising Prevotella histicola, wherein the Prevotella histicola is a strain comprising at least 85% sequence identity to the nucleotide sequence of the Prevotella histicola Strain B 50329 (NRRL accession number B 50329) for use in treating psoriatic arthritis is described herein.

[553] In some aspects, uses of a bacterial composition for the preparation of a medicament for treating psoriatic arthritis (e.g., mild to moderate psoriatic arthritis, or mild, moderate, or severe psoriatic arthritis) are disclosed.

[554] In some aspects, use of a bacterial composition for the preparation of a medicament for treating psoriatic arthritis wherein the bacterial composition comprises Prevotella histicola, wherein the Prevotella histicola is a strain comprising at least 85% sequence identity to the nucleotide sequence of the Prevotella histicola Strain B 50329 (NRRL accession number B 50329) is described herein. In some embodiments, the psoriatic arthritis comprises mild psoriatic arthritis. In some embodiments, the psoriatic arthritis comprises moderate psoriatic arthritis. In some embodiments, the psoriatic arthritis comprises severe psoriatic arthritis.

[555] In some aspects, bacterial compositions for use of treating atopic dermatitis (e.g., mild to moderate atopic dermatitis, or mild, moderate, or severe atopic dermatitis) are disclosed.

[556] In some aspects, a bacterial composition comprising Prevotella histicola, wherein the Prevotella histicola is a strain comprising at least 85% sequence identity to the nucleotide sequence of the Prevotella histicola Strain B 50329 (NRRL accession number B 50329) for use in treating atopic dermatitis is described herein.

[557] In some aspects, uses of a bacterial composition for the preparation of a medicament for treating atopic dermatitis (e.g., mild to moderate atopic dermatitis, or mild, moderate, or severe atopic dermatitis) are disclosed.

[558] In some aspects, use of a bacterial composition for the preparation of a medicament for treating atopic dermatitis wherein the bacterial composition comprises Prevotella histicola, wherein the Prevotella histicola is a strain comprising at least 85% sequence identity to the nucleotide sequence of the Prevotella histicola Strain B 50329 (NRRL accession number B 50329) is described herein. In some embodiments, the atopic dermatitis comprises mild atopic dermatitis. In some embodiments, the atopic dermatitis comprises moderate atopic dermatitis. In some embodiments, the atopic dermatitis comprises mild to moderate atopic dermatitis.

[559] Numerous embodiments are further provided that can be applied to any aspect of the methods and compositions described herein. For example, in some embodiments, the Prevotella histicola is a strain comprising at least 99.9% sequence identity to the nucleotide sequence of the Prevotella histicola Strain B 50329 (NRRL accession number B 50329). In some embodiments, the Prevotella histicola is the Prevotella histicola Strain B 50329 (NRRL accession number B 50329). In some embodiments, the bacterial composition is administered orally. In some embodiments, the bacterial composition is formulated as a tablet. In some embodiments, the bacterial composition is formulated as a capsule.

[560] In some embodiments, the bacterial composition is administered once daily. In some embodiments, the bacterial composition is administered once daily for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. In some embodiments, the bacterial composition is administered once daily for at least 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. In some embodiments, the psoriasis is mild to moderate psoriasis. In some embodiments, the atopic dermatitis is mild, moderate, or severe atopic dermatitis.

[561] In some embodiments, the bacterial composition is administered twice daily. In some embodiments, the bacterial composition is administered twice daily for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. In some embodiments, the bacterial composition is administered twice daily for at least 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. In some embodiments, the psoriasis is mild to moderate psoriasis. In some embodiments, the atopic dermatitis is mild, moderate, or severe atopic dermatitis.

Metabolic Disorders

[562] In some embodiments, the methods and compositions described herein relate to the treatment or prevention of a metabolic disease or disorder a, such as type II diabetes, impaired glucose tolerance, insulin resistance, obesity, hyperglycemia, hyperinsulinemia, fatty liver, non-alcoholic steatohepatitis, hypercholesterolemia, hypertension, hyperlipoproteinemia, hyperlipidemia, hypertriglylceridemia, ketoacidosis, hypoglycemia, thrombotic disorders, dyslipidemia, non-alcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH) or a related disease. In some embodiments, the related disease is cardiovascular disease, atherosclerosis, kidney disease, nephropathy, diabetic neuropathy, diabetic retinopathy, sexual dysfunction, dermatopathy, dyspepsia, or edema. In some embodiments, the methods and compositions described herein relate to the treatment of nonalcoholic fatty liver disease (NAFLD) and Nonalcoholic Steatohepatitis (NASH).

[563] The compositions described herein can be used, for example, for preventing or treating (reducing, partially or completely, the adverse effects of) a metabolic disease, such as type II diabetes, impaired glucose tolerance, insulin resistance, obesity, hyperglycemia, hyperinsulinemia, fatty liver, non-alcoholic steatohepatitis, hypercholesterolemia, hypertension, hyperlipoproteinemia, hyperlipidemia, hypertriglylceridemia, ketoacidosis, hypoglycemia, thrombotic disorders, dyslipidemia, non-alcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH), or a related disease. In some embodiments, the related disease is cardiovascular disease, atherosclerosis, kidney disease, nephropathy, diabetic neuropathy, diabetic retinopathy, sexual dysfunction, dermatopathy, dyspepsia, or edema.

Other Diseases and Disorders

[564] In some embodiments, the methods and compositions described herein relate to the treatment of liver diseases. Such diseases include, but are not limited to, Alagille Syndrome, Alcohol -Related Liver Disease, Alpha- 1 Antitrypsin Deficiency, Autoimmune Hepatitis, Benign Liver Tumors, Biliary Atresia, Cirrhosis, Galactosemia, Gilbert Syndrome, Hemochromatosis, Hepatitis A, Hepatitis B, Hepatitis C, Hepatic Encephalopathy, Intrahepatic Cholestasis of Pregnancy (ICP), Lysosomal Acid Lipase Deficiency (LAL-D), Liver Cysts, Liver Cancer, Newborn Jaundice, Primary Biliary Cholangitis (PBC), Primary Sclerosing Cholangitis (PSC), Reye Syndrome, Type I Glycogen Storage Disease, and Wilson Disease.

[565] The methods and compositions described herein may be used to treat neurodegenerative and neurological diseases. In some embodiments, the neurodegenerative and/or neurological disease is Parkinson’s disease, Alzheimer’s disease, prion disease, Huntington’s disease, motor neuron diseases (MND), spinocerebellar ataxia, spinal muscular atrophy, dystonia, idiopathicintracranial hypertension, epilepsy, nervous system disease, central nervous system disease, movement disorders, multiple sclerosis, encephalopathy, peripheral neuropathy or post-operative cognitive dysfunction. Dysbiosis

[566] In recent years, it has become increasingly clear that the gut microbiome (also called the “gut microbiota”) can have a significant impact on an individual’s health through microbial activity and influence (local and/or distal) on immune and other cells of the host (Walker, W.A., Dysbiosis. The Microbiota in Gastrointestinal Pathophysiology. Chapter 25. 2017; Weiss and Thierry, Mechanisms and consequences of intestinal dysbiosis. Cellular and Molecular Life Sciences. (2017) 74(16):2959-2977. Zurich Open Repository and Archive, doi.org/10.1007/s00018-017-2509-x)).

[567] A healthy host-gut microbiome homeostasis is sometimes referred to as a “eubiosis” or “normobiosis,” whereas a detrimental change in the host microbiome composition and/or its diversity can lead to an unhealthy imbalance in the microbiome, or a “dysbiosis” (Hooks and O’Malley. Dysbiosis and its discontents. American Society for Microbiology. Oct 2017. Vol. 8. Issue 5. mBio 8:e01492-17. https://doi.org/10.1128/mBio.01492-17).

Dysbiosis, and associated local or distal host inflammatory or immune effects, may occur where microbiome homeostasis is lost or diminished, resulting in: increased susceptibility to pathogens; altered host bacterial metabolic activity; induction of host proinflammatory activity and/or reduction of host anti-inflammatory activity. Such effects are mediated in part by interactions between host immune cells (e.g., T cells, dendritic cells, mast cells, NK cells, intestinal epithelial lymphocytes (IEC), macrophages and phagocytes) and cytokines, and other substances released by such cells and other host cells.

[568] A dysbiosis may occur within the gastrointestinal tract (a “gastrointestinal dysbiosis” or “gut dysbiosis”) or may occur outside the lumen of the gastrointestinal tract (a “distal dysbiosis”). Gastrointestinal dysbiosis is often associated with a reduction in integrity of the intestinal epithelial barrier, reduced tight junction integrity and increased intestinal permeability. Citi, S. Intestinal Barriers protect against disease, Science

359: 1098-99 (2018); Srinivasan et al., TEER measurement techniques for in vitro barrier model systems. J. Lab. Autom. 20: 107-126 (2015). A gastrointestinal dysbiosis can have physiological and immune effects within and outside the gastrointestinal tract.

[569] The presence of a dysbiosis has been associated with a wide variety of diseases and conditions including: infection, cancer, autoimmune disorders (e.g., systemic lupus erythematosus (SLE)) or inflammatory disorders (e.g., functional gastrointestinal disorders such as inflammatory bowel disease (IBD), ulcerative colitis, and Crohn’s disease), neuroinflammatory diseases (e.g., multiple sclerosis), transplant disorders (e.g., graft- versus-host disease), fatty liver disease, type I diabetes, rheumatoid arthritis, Sjogren’s syndrome, celiac disease, cystic fibrosis, chronic obstructive pulmonary disorder (COPD), and other diseases and conditions associated with immune dysfunction. Lynch et al., The Human Microbiome in Health and Disease, N. Engl. J. Med .375:2369-79 (2016), Carding et al., Dysbiosis of the gut microbiota in disease. Microb. Ecol. Health Dis. (2015); 26: 10: 3402/mehd.v26.2619; Levy et al, Dysbiosis and the Immune System, Nature Reviews Immunology 17:219 (April 2017)

[570] Exemplary bacterial compositions disclosed herein can treat a dysbiosis and its effects by modifying the immune activity present at the site of dysbiosis. As described herein, such compositions can modify a dysbiosis via effects on host immune cells, resulting in, e.g., an increase in secretion of anti-inflammatory cytokines and/or a decrease in secretion of pro-inflammatory cytokines, reducing inflammation in the subject recipient or via changes in metabolite production.

[571] Exemplary bacterial compositions disclosed herein that are useful for treatment of disorders associated with a dysbiosis contain one or more types of immunomodulatory bacteria (e.g., anti-inflammatory bacteria) derived from such bacteria. Such compositions are capable of affecting the recipient host’s immune function, in the gastrointestinal tract, and/or a systemic effect at distal sites outside the subject’s gastrointestinal tract.

[572] Exemplary bacterial compositions disclosed herein that are useful for treatment of disorders associated with a dysbiosis contain a population of immunomodulatory bacteria of a single bacterial species (e.g., a single strain) (e.g., anti-inflammatory bacteria). Such compositions are capable of affecting the recipient host’s immune function, in the gastrointestinal tract, and /or a systemic effect at distal sites outside the subject’s gastrointestinal tract.

[573] In one embodiment, bacterial compositions containing an isolated population of immunomodulatory bacteria (e.g., anti-inflammatory bacterial cells) are administered (e.g., orally) to a mammalian recipient in an amount effective to treat a dysbiosis and one or more of its effects in the recipient. The dysbiosis may be a gastrointestinal tract dysbiosis or a distal dysbiosis.

[574] In another embodiment, bacterial compositions provided herein can treat a gastrointestinal dysbiosis and one or more of its effects on host immune cells, resulting in an increase in secretion of anti-inflammatory cytokines and/or a decrease in secretion of pro-inflammatory cytokines, reducing inflammation in the subject recipient. [575] In another embodiment, the bacterial compositions can treat a gastrointestinal dysbiosis and one or more of its effects by modulating the recipient immune response via cellular and cytokine modulation to reduce gut permeability by increasing the integrity of the intestinal epithelial barrier.

[576] In another embodiment, the bacterial compositions can treat a distal dysbiosis and one or more of its effects by modulating the recipient immune response at the site of dysbiosis via modulation of host immune cells.

[577] Other exemplary bacterial compositions are useful for treatment of disorders associated with a dysbiosis, which compositions contain one or more types of bacteria capable of altering the relative proportions of host immune cell subpopulations, e.g., subpopulations of T cells, immune lymphoid cells, dendritic cells, NK cells and other immune cells, or the function thereof, in the recipient.

[578] Other exemplary bacterial compositions are useful for treatment of disorders associated with a dysbiosis, which compositions contain a population of immunomodulatory bacteria of a single bacterial species e.g., a single strain) capable of altering the relative proportions of immune cell subpopulations, e.g., T cell subpopulations, immune lymphoid cells, NK cells and other immune cells, or the function thereof, in the recipient subject.

[579] In one embodiment, provided herein are methods of treating a gastrointestinal dysbiosis and one or more of its effects by orally administering to a subject in need thereof a bacterial composition which alters the microbiome population existing at the site of the dysbiosis. The bacterial composition can contain one or more types of immunomodulatory bacteria or a population of immunomodulatory bacteria of a single bacterial species (e.g., a single strain).

[580] In one embodiment, provided herein are methods of treating a distal dysbiosis and one or more of its effects by orally administering to a subject in need thereof a bacterial composition which alters the subject’s immune response outside the gastrointestinal tract. The bacterial composition can contain one or more types of immunomodulatory bacteria or a population of immunomodulatory bacteria of a single bacterial species (e.g., a single strain).

[581] In exemplary embodiments, bacterial compositions useful for treatment of disorders associated with a dysbiosis stimulate secretion of one or more anti-inflammatory cytokines by host immune cells. Anti-inflammatory cytokines include, but are not limited to, IL- 10, IL-13, IL-9, IL-4, IL-5, TGFP, and combinations thereof. In other exemplary embodiments, bacterial compositions useful for treatment of disorders associated with a dysbiosis that decrease (e.g., inhibit) secretion of one or more pro-inflammatory cytokines by host immune cells. Pro-inflammatory cytokines include, but are not limited to, IFNy, IL-12p70, IL-la, IL-6, IL-8, MCP1, MIPla, MIPip, TNFa, and combinations thereof. Other exemplary cytokines are known in the art and are described herein.

[582] In another aspect, the provided herein is a method of treating or preventing a disorder associated with a dysbiosis in a subject in need thereof, comprising administering (e.g., orally administering) to the subject a bacterial composition in the form of a probiotic or medical food comprising bacteria an amount sufficient to alter the microbiome at a site of the dysbiosis, such that the disorder associated with the dysbiosis is treated.

[583] In another embodiment, a bacterial composition provided herein in the form of a probiotic or medical food may be used to prevent or delay the onset of a dysbiosis in a subject at risk for developing a dysbiosis.

Infection

[584] Inflammation can be a protective response to harmful stimuli, such as invading pathogens, damaged cells, toxic compounds, or cancerous cells. However, excessive inflammatory responses to such stimuli can result in serious adverse effects, including tissue damage and even death. For example, production of pro-inflammatory cytokines such as interleukin-8 (IL-8), interleukin-6 (IL-6), interleukin-1 beta (IL-1 p), and tumor necrosis factor alpha (TNFa) in response to many viral infections is one of the primary causes of the adverse symptoms associated with infection (including, in some cases, death). For example, release of inflammatory cytokines has been associated with disease severity resulting from infection by a number of viruses, including infection by coronaviruses (e.g., SARS-CoV-2, the virus that causes Coronavirus Disease 2019 (COVID-19)), influenza viruses, and respiratory syncytial viruses. For example, patients with severe COVID-19 often exhibit elevated levels of inflammatory cytokines in their lungs, which contributes to lung damage experienced by the COVID-19 patients.

[585] In some embodiments, the methods and compositions described herein relate to the treatment or prevention of bacterial septic shock, cytokine storm and/or viral infection.

[586] In some embodiments, the methods and compositions described herein relate to the treatment or prevention of a viral infection such as a respiratory viral infection, such as a coronavirus infection (e.g., a MERS (Middle East Respiratory Syndrome) infection, a severe acute respiratory syndrome (SARS) infection, such as a SARS-CoV-2 infection), an influenza infection, and/or a respiratory syncytial virus infection. In some embodiments, the methods and solid dosage forms described herein provided herein are for the treatment of a coronavirus infection (e.g., a MERS infection, a severe acute respiratory syndrome (SARS) infection, such as a SARS-CoV-2 infection). In some embodiments, provided herein are methods and solid dosage forms for treating COVID-19.

[587] In some embodiments, the methods and compositions described herein relate to the treatment or prevention of a viral infection. In some embodiments, the infection is a coronavirus infection, an influenza infection, and/or a respiratory syncytial virus infection. In some embodiments the viral infection is a SARS-CoV-2 infection.

[588] In some embodiments, an additional therapy is administered to the subject. In some embodiments, the additional therapy comprises an antiviral medication. In some embodiments, the additional therapy comprises an antiviral medication such as ribavirin, neuraminidase inhibitor, protease inhibitor, recombinant interferons, antibodies, oseltamivir, zanamivir, peramivir or baloxavir marboxil. In some embodiments, the additional therapy comprises hydroxychloroquine and/or chloroquine. In some embodiments, the additional therapy comprises remdesivir. In some embodiments, the additional therapy comprises plasma from a subject who has recovered from infection by the same virus that is infecting the subject (e.g., plasma from a subject who has recovered from SARS-CoV-2 infection). In some embodiments, the additional therapy comprises an anti-inflammatory agent such as NSAIDs or anti-inflammatory steroids. In some embodiments, the additional therapy comprises dexamethasone.

[589] In some embodiments, the additional therapy comprises an antibody specific for IL- 6 and/or the IL-6 receptor. In some embodiments, the additional therapy comprises tocilizumab (Actemra®). In some embodiments, the additional therapy comprises sarilumab (Kevzara®).

[590] In some embodiments, the additional therapy can comprise an anti-viral therapy. For example, the anti-viral therapy can comprise a nucleotide analog, such as remdesivir, galidesivir or clevudine; a viral RNA polymerase inhibitor such as favipiravir or galidesivir; a protease inhibitor such as ritonavir, darunavir, or danoprevir; an inhibitor of viral membrane fusion such as umifenovir; and/or anti-SARS-CoV-2 plasma. [591] In some embodiments, the additional therapy can comprise an anti-inflammatory therapy. For example, the anti-inflammatory therapy can comprise a corticosteroid; sirolimus; anakinra; filamod; or an antibody. In some embodiments, the antibody can comprise a GMSF inhibitor, such as lenzilumab or gimsilumab; an anti-ILl beta inhibitor such as canakinumab; an IL-6 inhibitor such as tocilizumab or siltuximab; an IL-6R inhibitor such as sarilumab; and/or a CCR5 antagonist such as leronlimab.

[592] In some embodiments, the additional therapy can comprise a JAK inhibitor such as baricitinib, ruxolitinib, tofacitinib, and/or pacritinib.

[593] In some embodiments, the additional therapy can comprise a TLR7 agonist such as imiquimod or reisquimod.

[594] In some embodiments, the additional therapy can comprise a cell-based therapy. For example, the cell-based therapy can comprise Remestemcel- L; bone marrow stem cell therapy, such as MultiStem or Bm-Allo-MSC; mesenchymal stromal cells; and/or adipose derived mesenchymal stem cells such as AstroStem.

[595] In some embodiments, the additional therapy can comprise an ACE receptor inhibitor.

[596] In some embodiments, the additional therapy can comprise a regulator of the Sigma 1 and/or Sigma 2 receptor.

EXEMPLARY EMBODIMENTS

1. A method of treating a condition in a human subject comprising orally administering to the human subject a solid dosage form comprising a dose of about 1.6 x IO¹⁰ cells to about 16 x 10¹¹ cells of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the solid dosage form comprises an enteric coating; and wherein the enteric coating is at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dosage form (e.g., between about 5 mg to about 31 mg per size 0 capsule) (e.g., or an equivalent coating level for the given sized solid dosage form).

2. The method of embodiment 1, wherein the enteric coating is at a coating level of about 1 mg/cm² (e.g., about 5 mg per size 0 capsule); about 1.7 mg/cm² (e.g., about 9 mg per size 0 capsule); about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule); about 3.7 mg/cm² (e.g., about 19 mg per size 0 capsule); about 4.8 mg/cm² (e.g., about 25 mg per size 0 capsule); or about 6 mg/cm² (e.g., about 31 mg per size 0 capsule) per solid dosage form (e.g., or an equivalent coating level for the given sized solid dosage form). 3. The method of embodiment 1, wherein the enteric coating is at a coating level of about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule per solid dosage form (e.g., or an equivalent coating level for the given sized solid dosage form).

4. The method of any one of embodiments 1 to 3, wherein the condition comprises psoriasis, optionally wherein the psoriasis is mild, moderate, or severe psoriasis.

5. The method of any one of embodiments 1 to 3, wherein the condition comprises atopic dermatitis, optionally wherein the atopic dermatitis is mild, moderate, or severe atopic dermatitis.

6. The method of any one of embodiments 1 to 3, wherein the condition comprises psoriatic arthritis, optionally wherein the psoriatic arthritis is mild, moderate, or severe psoriatic arthritis.

7. The method of any one of embodiments 1 to 3, wherein the condition comprises an inflammatory disease.

8. The method of embodiment 7, the inflammatory disease is a Thl, Th2, or Thl7 inflammatory disease.

9. The method of any one of embodiments 1 to 3, wherein the condition comprises an immune disorder.

10. The method of any one of embodiments 1 to 3, wherein the condition comprises an autoimmune disease.

11. The method of any one of embodiments 1 to 3, wherein the condition comprises a metabolic disease.

12. The method of any one of embodiments 1 to 3, wherein the condition comprises a dysbiosis.

13. The method of any one of embodiments 1 to 3, wherein the condition comprises bacterial septic shock, cytokine storm and/or a viral infection.

14. The method of any one of embodiments 1 to 13, wherein the dose comprises about 8 x IO¹⁰ cells to about 8 x 10¹¹ cells.

15. The method of embodiment 14, wherein the dose comprises 1.6 x 10¹¹ cells to about 6.4 x 10¹¹ cells.

16. The method of embodiment 14, wherein the dose comprises about 8 x IO¹⁰ cells.

17. The method of embodiment 14, wherein the dose comprises about 1.6 x 10¹¹ cells.

18. The method of embodiment 14, wherein the dose comprises about 3.2 x 10¹¹ cells.

19. The method of embodiment 14, wherein the dose comprises about 6.4 x 10¹¹ cells. 20. The method of any one of embodiments 1 to 19, wherein the dose is administered to the subject once daily.

21. The method of any one of embodiments 1 to 19, wherein the dose is administered to the subject twice daily.

22. The method of any one of embodiments 1 to 21, wherein the solid dosage form comprises about 8 x IO¹⁰ cells per solid dosage form.

23. The method of any one of embodiments 1 to 21, wherein the solid dosage form comprises about 1.6 x 10¹¹ cells per solid dosage form.

24. The method of any one of embodiments 1 to 21, wherein the solid dosage form comprises about 3.2 x 10¹¹ cells per solid dosage form.

25. The method of any one of embodiments 1 to 19, wherein one solid dosage form is administered to the subject once daily.

26. The method of any one of embodiments 1 to 19, wherein one solid dosage form is administered to the subject twice daily.

27. The method of any one of embodiments 1 to 19, wherein two solid dosage forms are administered to the subject once daily.

28. The method of any one of embodiments 1 to 19, wherein two solid dosage forms are administered to the subject twice daily.

29. The method of any one of embodiments 1 to 14, wherein one solid dosage form is administered once daily, wherein the solid dose form comprises a dose of about 8 x IO¹⁰ total cells.

30. The method of any one of embodiments 1 to 14, wherein one solid dosage form is administered once daily, wherein the solid dosage form comprises a dose of about 1.6 x 10¹¹ total cells.

31. The method of any one of embodiments 1 to 14, wherein one solid dosage form is administered once daily, wherein the solid dosage form comprises a dose of about 3.2 x 10¹¹ total cells.

32. The method of any one of embodiments 22 to 24, wherein one solid dosage form is administered to the subject twice daily.

33. The method of any one of embodiments 22 to 24, wherein two solid dosage forms are administered to the subject once daily. 34. The method of any one of embodiments 1 to 14, wherein two solid dosage forms are administered once daily, wherein each solid dose form comprises a dose of about 8 x IO¹⁰ total cells.

35. The method of any one of embodiments 1 to 14, wherein two solid dosage forms are administered once daily, wherein each solid dosage form comprises a dose of about 1.6 x 10¹¹ total cells.

36. The method of any one of embodiments 1 to 14, wherein two solid dosage forms are administered once daily, wherein each solid dosage form comprises a dose of about 3.2 x 10¹¹ total cells.

37. The method of any one of embodiments 1 to 14, wherein two solid dosage forms are administered to the subject twice daily.

38. The method of any one of embodiments 1 to 37, wherein the solid dosage form comprises a capsule.

39. The method of any one of embodiments 1 to 20, 22 to 25, 27, 29 to 31, 33 to 36, wherein the one or more solid dosage forms are administered once daily for at least 8 weeks.

40. The method of embodiment 39, wherein the one or more solid dosage forms are administered once daily for at least 12 weeks.

41. The method of embodiment 39, wherein the one or more solid dosage forms are administered once daily for at least 16 weeks.

42. The method of embodiment 39, wherein the one or more solid dosage forms are administered once daily for at least 20 weeks.

43. The method of embodiment 39, wherein the one or more solid dosage forms are administered once daily for at least 24 weeks.

44. The method of embodiment 39, wherein the one or more solid dosage forms are administered once daily for at least 28 weeks.

45. The method of embodiment 39, wherein the one or more solid dosage forms are administered once daily for at least 32 weeks.

46. The method of embodiment 39, wherein the one or more solid dosage forms are administered once daily for at least 36 weeks.

47. The method of embodiment 39, wherein the one or more solid dosage forms are administered once daily for at least 40 weeks. 48. The method of embodiment 39, wherein the one or more solid dosage forms are administered once daily for at least 44 weeks.

49. The method of embodiment 39, wherein the one or more solid dosage forms are administered once daily for at least 48 weeks.

50. The method of embodiment 39, wherein the one or more solid dosage forms are administered once daily for at least 52 weeks.

51. The method of any one of embodiments 1 to 50, wherein the one or more solid dosage forms are administered in combination with an additional therapy.

52. A method of treating psoriasis, optionally mild, moderate, or severe psoriasis, in a human subject comprising orally administering to the human subject a dose of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the dose is administered to the human subject for at least 8 weeks, wherein the dose is formulated in a solid dosage form, wherein the solid dosage form comprises about 3.2 x 10¹¹ total cells of the bacteria, optionally wherein the solid dosage form is a capsule; wherein the solid dosage form comprises an enteric coating; and wherein the enteric coating is at a coating level of about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule per solid dosage form (e.g., or an equivalent coating level for the given sized solid dosage form)).

53. The method of embodiment 52, wherein the solid dosage form is administered once daily for at least 12 weeks.

54. The method of embodiment 52, wherein the solid dosage form is administered once daily for at least 16 weeks.

55. The method of embodiment 52, wherein the solid dosage form is administered once daily for at least 20 weeks.

56. The method of embodiment 52, wherein the solid dosage form is administered once daily for at least 24 weeks.

57. The method of embodiment 52, wherein the solid dosage form is administered once daily for at least 28 weeks.

58. The method of embodiment 52, wherein the solid dosage form is administered once daily for at least 32 weeks.

59. The method of embodiment 52, wherein solid dosage form is administered once daily for at least 36 weeks. 60. The method of embodiment 52, wherein the solid dosage form is administered once daily for at least 40 weeks.

61. The method of embodiment 52, wherein the solid dosage form is administered once daily for at least 44 weeks.

62. The method of embodiment 52, wherein the solid dosage form is administered once daily for at least 48 weeks.

63. The method of embodiment 52, wherein the solid dosage form is administered once daily for at least 52 weeks.

64. The method of any one of embodiments 52 to 63, wherein the solid dosage form is administered in combination with an additional therapy.

65. A method of treating psoriatic arthritis, optionally wherein the psoriatic arthritis is mild, moderate, or severe psoriatic arthritis, in a human subject comprising orally administering to the human subject a dose of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the dose is administered to the human subject for at least 8 weeks, wherein the dose is formulated in a solid dosage form, wherein the solid dosage form comprises about 3.2 x 10¹¹ total cells of the bacteria, optionally wherein the solid dosage form is a capsule; wherein the solid dosage form comprises an enteric coating; and wherein the enteric coating is at a coating level of about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule per solid dosage form (e.g., or an equivalent coating level for the given sized solid dosage form)).

66. The method of embodiment 65, wherein the solid dosage form is administered once daily for at least 12 weeks.

67. The method of embodiment 65, wherein the solid dosage form is administered once daily for at least 16 weeks.

68. The method of embodiment 65, wherein the solid dosage form is administered once daily for at least 20 weeks.

69. The method of embodiment 65, wherein the solid dosage form is administered once daily for at least 24 weeks.

70. The method of embodiment 65, wherein the solid dosage form is administered once daily for at least 28 weeks.

71. The method of embodiment 65, wherein the solid dosage form is administered once daily for at least 32 weeks. 72. The method of embodiment 65, wherein solid dosage form is administered once daily for at least 36 weeks.

73. The method of embodiment 65, wherein the solid dosage form is administered once daily for at least 40 weeks.

74. The method of embodiment 65, wherein the solid dosage form is administered once daily for at least 44 weeks.

75. The method of embodiment 65, wherein the solid dosage form is administered once daily for at least 48 weeks.

76. The method of embodiment 65, wherein the solid dosage form is administered once daily for at least 52 weeks.

77. The method of any one of embodiments 65 to 76, wherein the solid dosage form is administered in combination with an additional therapy.

78. A method of treating atopic dermatitis, optionally mild, moderate, or severe atopic dermatitis, in a human subject comprising orally administering to the human subject a dose of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the dose is administered to the human subject for at least 8 weeks, wherein the dose is formulated in a solid dosage form, wherein the solid dosage form comprises about 3.2 x 10¹¹ total cells of the bacteria, optionally wherein the solid dosage form is optionally wherein the solid dosage form is a capsule; wherein the solid dosage form comprises an enteric coating; and wherein the enteric coating is at a coating level of about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule per solid dosage form (e.g., or an equivalent coating level for the given sized solid dosage form)).

79. The method of embodiment 78, wherein the solid dosage form is administered once daily for at least 12 weeks.

80. The method of embodiment 78, wherein the solid dosage form is administered once daily for at least 16 weeks.

81. The method of embodiment 78, wherein the solid dosage form is administered once daily for at least 20 weeks.

82. The method of embodiment 78, wherein the solid dosage form is administered once daily for at least 24 weeks.

83. The method of embodiment 78, wherein the solid dosage form is administered once daily for at least 28 weeks. 84. The method of embodiment 78, wherein the solid dosage form is administered once daily for at least 32 weeks.

85. The method of embodiment 78, wherein solid dosage form is administered once daily for at least 36 weeks.

86. The method of embodiment 78, wherein the solid dosage form is administered once daily for at least 40 weeks.

87. The method of embodiment 78, wherein the solid dosage form is administered once daily for at least 44 weeks.

88. The method of embodiment 78, wherein the solid dosage form is administered once daily for at least 48 weeks.

89. The method of embodiment 78, wherein the solid dosage form is administered once daily for at least 52 weeks.

90. The method of any one of embodiments 78 to 89, wherein the solid dosage form is administered in combination with an additional therapy, e.g., wherein the additional therapy comprises an emollient, optionally wherein the emollient comprises a bland additive-free, sodium lauryl sulfate (SLS)-free, and fragrance-free emollient cream, gel, or ointment, optionally wherein the emollient is used at least daily or at least twice daily.

91. A method of treating psoriasis, optionally mild, moderate, or severe psoriasis, in a human subject comprising orally administering to the human subject a dose of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the dose is administered to the human subject for at least 8 weeks, wherein the dose is formulated in a solid dosage form, wherein the solid dosage form comprises about 8 x IO¹⁰ total cells of the bacteria, optionally wherein the solid dosage form is a capsule; wherein the solid dosage form comprises an enteric coating; and wherein the enteric coating is at a coating level of about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule per solid dosage form (e.g., or an equivalent coating level for the given sized solid dosage form)).

92. The method of embodiment 91, wherein the solid dosage form is administered once daily for at least 12 weeks.

93. The method of embodiment 91, wherein the solid dosage form is administered once daily for at least 16 weeks.

94. The method of embodiment 91, wherein the solid dosage form is administered once daily for at least 20 weeks. 95. The method of embodiment 91, wherein the solid dosage form is administered once daily for at least 24 weeks.

96. The method of embodiment 91, wherein the solid dosage form is administered once daily for at least 28 weeks.

97. The method of embodiment 91, wherein the solid dosage form is administered once daily for at least 32 weeks.

98. The method of embodiment 91, wherein solid dosage form is administered once daily for at least 36 weeks.

99. The method of embodiment 91, wherein the solid dosage form is administered once daily for at least 40 weeks.

100. The method of embodiment 91, wherein the solid dosage form is administered once daily for at least 44 weeks.

101. The method of embodiment 91, wherein the solid dosage form is administered once daily for at least 48 weeks.

102. The method of embodiment 91, wherein the solid dosage form is administered once daily for at least 52 weeks.

103. The method of any one of embodiments 91 to 102, wherein the solid dosage form is administered in combination with an additional therapy.

104. A method of treating psoriatic arthritis, optionally mild, moderate, or severe psoriatic arthritis, in a human subject comprising orally administering to the human subject a dose of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the dose is administered to the human subject for at least 8 weeks, wherein the dose is formulated in a solid dosage form, wherein the solid dosage form comprises about 8 x 10¹⁰ total cells of the bacteria, optionally wherein the solid dosage form is a capsule; wherein the solid dosage form comprises an enteric coating; and wherein the enteric coating is at a coating level of about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule per solid dosage form (e.g., or an equivalent coating level for the given sized solid dosage form)).

105. The method of embodiment 104, wherein the solid dosage form is administered once daily for at least 12 weeks.

106. The method of embodiment 104, wherein the solid dosage form is administered once daily for at least 16 weeks. 107. The method of embodiment 104, wherein the solid dosage form is administered once daily for at least 20 weeks.

108. The method of embodiment 104, wherein the solid dosage form is administered once daily for at least 24 weeks.

109. The method of embodiment 104, wherein the solid dosage form is administered once daily for at least 28 weeks.

110. The method of embodiment 104, wherein the solid dosage form is administered once daily for at least 32 weeks.

111. The method of embodiment 104, wherein solid dosage form is administered once daily for at least 36 weeks.

112. The method of embodiment 104, wherein the solid dosage form is administered once daily for at least 40 weeks.

113. The method of embodiment 104, wherein the solid dosage form is administered once daily for at least 44 weeks.

114. The method of embodiment 104, wherein the solid dosage form is administered once daily for at least 48 weeks.

115. The method of embodiment 104, wherein the solid dosage form is administered once daily for at least 52 weeks.

116. The method of any one of embodiments 104 to 115, wherein the solid dosage form is administered in combination with an additional therapy.

117. A method of treating atopic dermatitis, optionally mild, moderate, or severe atopic dermatitis, in a human subject comprising orally administering to the human subject a dose of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the dose is administered to the human subject for at least 8 weeks, wherein the dose is formulated in a solid dosage form, wherein the solid dosage form comprises about 8 x 10¹⁰ total cells of the bacteria, optionally wherein the solid dosage form is a capsule; wherein the solid dosage form comprises an enteric coating; and wherein the enteric coating is at a coating level of about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule per solid dosage form (e.g., or an equivalent coating level for the given sized solid dosage form)).

118. The method of embodiment 117, wherein the solid dosage form is administered once daily for at least 12 weeks. 119. The method of embodiment 117, wherein the solid dosage form is administered once daily for at least 16 weeks.

120. The method of embodiment 117, wherein the solid dosage form is administered once daily for at least 20 weeks.

121. The method of embodiment 117, wherein the solid dosage form is administered once daily for at least 24 weeks.

122. The method of embodiment 117, wherein the solid dosage form is administered once daily for at least 28 weeks.

123. The method of embodiment 117, wherein the solid dosage form is administered once daily for at least 32 weeks.

124. The method of embodiment 117, wherein solid dosage form is administered once daily for at least 36 weeks.

125. The method of embodiment 117, wherein the solid dosage form is administered once daily for at least 40 weeks.

126. The method of embodiment 117, wherein the solid dosage form is administered once daily for at least 44 weeks.

127. The method of embodiment 117, wherein the solid dosage form is administered once daily for at least 48 weeks.

128. The method of embodiment 117, wherein the solid dosage form is administered once daily for at least 52 weeks.

129. The method of any one of embodiments 117 to 128, wherein the solid dosage forms are administered in combination with an additional therapy, e.g., wherein the additional therapy comprises an emollient, optionally wherein the emollient comprises a bland additive-free, sodium lauryl sulfate (SLS)-free, and fragrance-free emollient cream, gel, or ointment, optionally wherein the emollient is used at least daily or at least twice daily.

130. A method of treating inflammation in a human subject comprising orally administering to the human subject a dose of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the dose is administered to the human subject for at least 8 weeks, wherein the dose is formulated in a solid dosage form, wherein the solid dosage form comprises about 3.2 x 10¹¹ total cells of the bacteria, optionally wherein the solid dosage form is a capsule; wherein the solid dosage form comprises an enteric coating; and wherein the enteric coating is at a coating level of about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule per solid dosage form (e.g., or an equivalent coating level for the given sized solid dosage form)).

131. The method of embodiment 130, wherein the solid dosage form is administered once daily for at least 12 weeks.

132. The method of embodiment 130, wherein the solid dosage form is administered once daily for at least 16 weeks.

133. The method of embodiment 130, wherein the solid dosage form is administered once daily for at least 20 weeks.

134. The method of embodiment 130, wherein the solid dosage form is administered once daily for at least 24 weeks.

135. The method of embodiment 130, wherein the solid dosage form is administered once daily for at least 28 weeks.

136. The method of embodiment 130, wherein the solid dosage form is administered once daily for at least 32 weeks.

137. The method of embodiment 130, wherein solid dosage form is administered once daily for at least 36 weeks.

138. The method of embodiment 130, wherein the solid dosage form is administered once daily for at least 40 weeks.

139. The method of embodiment 130, wherein the solid dosage form is administered once daily for at least 44 weeks.

140. The method of embodiment 130, wherein the solid dosage form is administered once daily for at least 48 weeks.

141. The method of embodiment 130, wherein the solid dosage form is administered once daily for at least 52 weeks.

142. The method of embodiment 130, wherein the solid dosage form is administered once a day.

143. The method of embodiment 130, wherein the solid dosage form is administered twice a day.

144. The method of any one of embodiments 130 to 143, wherein the inflammation comprises Thl inflammation.

145. The method of any one of embodiments 130 to 143, wherein the inflammation comprises Th2 inflammation. 146. The method of any one of embodiments 130 to 143, wherein the inflammation comprises Thl7 inflammation.

147. The method of any one of embodiments 130 to 146, wherein the solid dosage form is administered in combination with an additional therapy.

148. A method of treating inflammation in a human subject comprising orally administering to the human subject a dose of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the dose is administered to the human subject for at least 8 weeks, wherein the dose is formulated in a solid dosage form, wherein the solid dosage form comprises about 8 x IO¹⁰ total cells of the bacteria, optionally wherein the solid dosage form is a capsule; wherein the solid dosage form comprises an enteric coating; and wherein the enteric coating is at a coating level of about 2.7 mg/cm² (e.g., about 14 mg per size 0 capsule per solid dosage form (e.g., or an equivalent coating level for the given sized solid dosage form)).

149. The method of embodiment 148, wherein the solid dosage form is administered once daily for at least 12 weeks.

150. The method of embodiment 148, wherein the solid dosage form is administered once daily for at least 16 weeks.

151. The method of embodiment 148, wherein the solid dosage form is administered once daily for at least 20 weeks.

152. The method of embodiment 148, wherein the solid dosage form is administered once daily for at least 24 weeks.

153. The method of embodiment 148, wherein the solid dosage form is administered once daily for at least 28 weeks.

154. The method of embodiment 148, wherein the solid dosage form is administered once daily for at least 32 weeks.

155. The method of embodiment 148, wherein solid dosage form is administered once daily for at least 36 weeks.

156. The method of embodiment 148, wherein the solid dosage form is administered once daily for at least 40 weeks.

157. The method of embodiment 148, wherein the solid dosage form is administered once daily for at least 44 weeks. 158. The method of embodiment 148, wherein the solid dosage form is administered once daily for at least 48 weeks.

159. The method of embodiment 148, wherein the solid dosage form is administered once daily for at least 52 weeks.

160. The method of embodiment 148, wherein the solid dosage form is administered once a day.

161. The method of embodiment 148, wherein the solid dosage form is administered twice a day.

162. The method of any one of embodiments 148 to 161, wherein the inflammation comprises Thl inflammation.

163. The method of any one of embodiments 148 to 161, wherein the inflammation comprises Th2 inflammation.

164. The method of any one of embodiments 148 to 161, wherein the inflammation comprises Thl7 inflammation.

165. The method of any one of embodiments 148 to 164, wherein the solid dosage form is administered in combination with an additional therapy.

166. The method of any one of embodiments 1 to 165, wherein the enteric coating comprises a methacrylic acid ethyl acrylate (MAE) copolymer (1 : 1) such as Eudragit L copolymer, such as Eudragit L 30 D-55.

167. The method of any one of embodiments 1 to 166, wherein the solid dosage form comprises a capsule.

168. The method of any one of embodiments 1 to 167, wherein the solid dosage form comprises a size 0 capsule.

EXAMPLES

Example 1: Prevotella histicola Strain B Treatment for Psoriasis

[597] Psoriasis is a chronic immune-mediated type 1/3 (Thl/Thl7) inflammatory skin disease in which hyperactive T cells trigger excessive keratinocyte proliferation. This results in the formation of raised erythematous plaques with scaling. Psoriatic lesions can appear anywhere on the body but are most often seen on the knees, elbows, scalp, and lumbar area. Critical events in the inflammatory process include activation of Langerhans cells and T cells, selective trafficking of activated T cells to the skin, and induction of an inflammatory cytokine and chemokine cascade in skin lesions. Clinical data have validated the role of anti-TNFa, anti-IL-17, and anti-IL-23 therapy in moderate to severe psoriasis. For patients with mild to moderate psoriasis, therapy usually involves topical agents (topical corticosteroids, vitamin D3 analogs), with topical corticosteroids providing the greatest range of efficacy and a wide range of formulations. More recently, physicians are prescribing apremilast, a first-in-class oral PDE4 inhibitor, ahead of biological therapy, which includes etanercept, infliximab, adalimumab, ustekinumab, and secukinumab.

[598] Prevotella histicola Strain B can be used for the treatment of psoriasis, e.g., at the doses and dosing regimens provided herein. The psoriasis can be mild, moderate, or severe psoriasis. The psoriasis can be mild to moderate psoriasis.

Dose:

[599] Cohort: 8 x 1O¹⁰ cells of Prevotella Strain B 50329 or matching placebo are administered as a capsule, once daily to subjects with psoriasis for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The capsule is a size 0 capsule that is enteric coated with Eudragit L30D-55 at a coating level to a weight gain of 14 mg/capsule.

[600] Cohort: 1.6 x 10¹¹ cells of Prevotella Strain B 50329 or matching placebo are administered as capsules, once daily to subjects with psoriasis for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The capsule is a size 0 capsule that is enteric coated with Eudragit L30D-55 at a coating level to a weight gain of 14 mg/capsule.

[601] Cohort: 3.2 x 10¹¹ cells of Prevotella Strain B 50329 or matching placebo are administered as capsules, once daily to subjects with psoriasis for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The capsule is a size 0 capsule that is enteric coated with Eudragit L30D-55 at a coating level to a weight gain of 14 mg/capsule.

[602] Cohort: 6.4 x 10¹¹ cells of Prevotella Strain B 50329 or matching placebo are administered as capsules, once daily to subjects with psoriasis for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The capsule is a size 0 capsule that is enteric coated with Eudragit L30D-55 at a coating level to a weight gain of 14 mg/capsule.

[603] Cohort: 8 x 10¹¹ cells of Prevotella Strain B 50329 or matching placebo are administered as capsules, once daily to subjects with psoriasis for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The capsule is a size 0 capsule that is enteric coated with Eudragit L30D-55 at a coating level to a weight gain of 14 mg/capsule.

[604] Cohort: 9.6 x 10¹¹ cells of Prevotella Strain B 50329 or matching placebo are administered as capsules, once daily to subjects with psoriasis for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The capsule is a size 0 capsule that is enteric coated with Eudragit L30D-55 at a coating level to a weight gain of 14 mg/capsule.

[605] Cohort: 12.8 x 10¹¹ cells of Prevotella Strain B 50329 or matching placebo are administered as capsules, once daily to subjects with psoriasis for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The capsule is a size 0 capsule that is enteric coated with Eudragit L30D-55 at a coating level to a weight gain of 14 mg/capsule.

Efficacy Assessments:

[606] The following endpoints can be evaluated prior to first administration of a bacterial composition described herein, and/or at intervals during administration (e.g., 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks) of a bacterial composition described herein and/or after administration has terminated (e.g., 2 and/or 4 and/or 24 weeks after termination):

Psoriasis Area and Severity Index Score

[607] The PASI score will be assessed as described by Langley and Ellis (2004). The PASI is a physician assessment that combines the assessment of the severity of and area affected by psoriasis into a single score in the range 0 (no disease) to 72 (maximal disease). The absolute PASI score in this study is used as part of inclusion criterion #4. The PASI percentage response rates are efficacy endpoints (i.e., PASL50, PASL75, PASL90, and PASI-100). For example, the percentage of participants who achieve a 75% or greater reduction in PASI score from baseline is represented by the PASI-75 value. Details of the PASI assessment will be provided in the study manual.

Lesion Severity Score

[608] The LSS is used to score the severity of psoriasis plaques (Patel and Tsui 2011). The dimensions of scaling, erythema, and plaque elevation are each scored on a scale from 0 to 4, and the total LSS is the numerical sum of the 3-dimensional scores observed at a single study visit.

Physician’s Global Assessment

[609] The National Psoriasis Foundation Psoriasis Score version of a static PGA is calculated by averaging the total body erythema, induration, and desquamation scores (Feldman and Krueger 2005). Erythema, induration, and desquamation will be scored on a 6-point scale, ranging from 0 (clear) to 5 (severe): the total PGA score is defined as the average of the erythema, induration, and desquamation scores. Details of the PGA assessment will be provided in the study manual.

Percent of Body Surface Area Involvement

[610] The percent of BSA involvement will be estimated for each participant, where 1% is approximately the area of the participant’s handprint (Walsh et al 2013). Details of the BSA assessment will be provided in the study manual.

[611] Walsh and colleagues proposed the product of the PGA and the BSA involvement as a simple and effective alternative for measuring severity of psoriasis in clinical trials (Walsh et al 2013).

Modified Nail Psoriasis Severity Index

[612] The mNAPSI is a numeric, reproducible, objective, and simple tool for physicians to evaluate the severity of nail bed psoriasis and nail matrix psoriasis by area of involvement in the nail unit (Cassell et al 2007). Details of conducting the mNAPSI will be provided in the study manual.

Dermatology Life Quality Index

[613] The DLQI is a patient reported outcomes instrument for assessing the impact of dermatologic conditions on patients’ quality of life (Finlay and Khan 1994). Details of administering the DLQI will be provided in the study manual.

Psoriasis Symptom Inventory

[614] The PSI is a patient reported outcomes instrument that is used to assess the severity of plaque psoriasis symptoms (Bushnell et al 2013). All symptoms (itch, redness, scaling, burning, cracking, stinging, flaking, and pain) are rated on a 5-point severity scale. The PSI demonstrated good construct validity and was sensitive to within-subject change (p < 0.0001). Details of administering the PSI will be provided in the study manual.

Pain

[615] Pain will be assessed by the SF-36 Bodily Pain Scale (SF-36 BPS) and the VAS Pain (Hawker et al 2011). Details of administering the pain assessments will be provided in the study manual.

Fatigue

[616] Consistent with a recent study of fatigue in psoriasis (Skoie et al 2017), fatigue will be assessed by the vitality subscale of the SF-36 (van der Heijden et al 2003) and a fatigue VAS (Wolfe 2004). Details of administering the fatigue assessments will be provided in the study manual.

Histologic Assessment

[617] Standard histology will be performed on skin plaque biopsies (including epidermal thickness, basal mitotic counts and immune cell infiltrates, immunohistochemistry). mRNA Transcription Analysis

[618] An mRNA transcription analysis will be performed on the skin plaque biopsies.

Blood Cytokine and Chemokine Analysis

[619] Blood samples will be stimulated ex vivo and analyzed for levels of cytokines and chemokines, including IL-1 beta, IL-2, IL-4, IL-6, IL-8, IL- 10, IL-12p40, IL- 17 A, TNFa, and IFNy.

References

Blake MR, Raker JM, Whelan K. Validity and reliability of the Bristol Stool Form Scale in healthy adults and patients with diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther. 2016;44:693-703.

Bornkamp B. Practical considerations for using functional uniform prior distributions for dose-response estimation in clinical trials. Biom J. 2014;56(6):947-62.

Bushnell DM, Martin ML, McCarrier K, et al. Validation of the Psoriasis Symptom Inventory (PSI), a patient-reported outcome measure to assess psoriasis symptom severity. J Dermatolog Treat. 2013;24(5):356-60.

Cassell SE, Bieber JD, Rich P, et al. The modified Nail Psoriasis Severity Index: validation of an instrument to assess psoriatic nail involvement in patients with psoriatic arthritis.

J Rheumatol. 2007 Jan;34(l): 123-9. de Groot PF, Belzer C, Aydin O, et al. Distinct fecal and oral microbiota composition in human type 1 diabetes, an observational study. PLoS One. 2017;12(12):e0188475.

Feldman SR, Krueger GG. Psoriasis assessment tools in clinical trials. Ann Rheum Dis. 2005;64(Suppl 2):ii65-8; discussion ii69-73.

Felix KM, Tahsin S, Wu HJ. Host-microbiota interplay in mediating immune disorders. Ann N Y Acad Sci. 2018;1417(l):57-70. Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI): a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994;19:210-6.

Hawker GA, Mian S, Kendzerska T, et al. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011;63 Suppl 1 ES240-52.

Hindson J. Multiple sclerosis: A possible link between multiple sclerosis and gut microbiota. Nat Rev Neurol. 2017;13(12):705.

Human Microbiome Project Consortium. A framework for human microbiome research. Nature. 2012;486:215-21.

Langley RG, Ellis CN. Evaluating psoriasis with Psoriasis Area and Severity Index, Psoriasis Global Assessment, and Lattice System Physician's Global Assessment. J Am Acad Dermatol. 2004;51(4):563-9.

Mangalam A, Shahi SK, Luckey D, et al. Human gut-derived commensal bacteria suppress CNS inflammatory and demyelinating disease. Cell Rep. 2017;20(6): 1269-77.

Marietta EV, Murray JA, Luckey DH, et al. Human gut-derived Prevotella histicola suppresses inflammatory arthritis in humanized mice. Arthritis Rheumatol. 2016;68(12):2878-88.

O’Donnell LJD, Virjee J, Heaton KW. Detection of pseudodiarrhoea by simple clinical assessment of intestinal transit rate. BMJ. 1990;300:439-40.

Patel RV, Tsui CL. Evaluating psoriasis: a review of the assessments most commonly used in clinical trials. Psoriasis Forum. 2011; 17(4):259-66. doi: 10.1177/247553031117a00403.

Skoie IM, Dalen I, Temowitz T, et al. Fatigue in psoriasis: a controlled study. Br J Dermatol. 2017;177(2):505-12.

Spiegelhalter DJ, Abrams KR, Myles JP. Bayesian approaches to clinical trials and healthcare evaluation. Chichester: John Wiley and Sons Ltd; 2004. 408 p. van der Heijden PG, van Buuren S, Fekkes M, et al. Unidimensionality and reliability under Mokken scaling of the Dutch language version of the SF-36. Qual Life Res. 2003;12: 189- 98.

Vandeputte D, Falony G, Vieira-Silva S, et al. Stool consistency is strongly associated with gut microbiota richness and composition, enterotypes and bacterial growth rates. Gut. 2016;65:57-62.

Vandeputte D, Kathagen G, D’hoe K, et al. Quantitative microbiome profiling links gut community variation to microbial load. Nature. 2017;551 :507-11.

Walsh JA, McFadden M, Woodcock J, et al. Product of the Physician Global Assessment and body surface area: a simple static measure of psoriasis severity in a longitudinal cohort. J Am Acad Dermatol. 2013;69(6):931-7.

Wolfe F. Fatigue assessments in rheumatoid arthritis: comparative performance of visual analog scales and longer fatigue questionnaires in 7760 patients. J Rheumatol.

2004;31(10): 1896-902.

Yan D, Issa N, Afifi L, et al. The role of the skin and gut microbiome in psoriatic disease. Curr Dermatol Rep. 2017;6:94-103.

Example 2: Additional Psoriasis Read-Outs

[620] Prevotella histicola Strain B can be used for the treatment of psoriasis, e.g., at the doses and dosing regimens provided herein. The psoriasis can be mild, moderate, or severe psoriasis. The psoriasis can be mild to moderate psoriasis.

Dose:

[621] Cohort: 8 x 1O¹⁰ cells of Prevotella Strain B 50329 or matching placebo are administered as a capsule, once daily to subjects with psoriasis for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The capsule is a size 0 capsule that is enteric coated with Eudragit L30D-55 at a coating level to a weight gain of 14 mg/capsule.

[622] Cohort: 1.6 x 10¹¹ cells of Prevotella Strain B 50329 or matching placebo are administered as capsules, once daily to subjects with psoriasis for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The capsule is a size 0 capsule that is enteric coated with Eudragit L30D-55 at a coating level to a weight gain of 14 mg/capsule. [623] Cohort: 3.2 * 10¹¹ cells of Prevotella Strain B 50329 or matching placebo are administered as capsules, once daily to subjects with psoriasis for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The capsule is a size 0 capsule that is enteric coated with Eudragit L30D-55 at a coating level to a weight gain of 14 mg/capsule.

[624] Cohort: 6.4 x 10¹¹ cells of Prevotella Strain B 50329 or matching placebo are administered as capsules, once daily to subjects with psoriasis for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The capsule is a size 0 capsule that is enteric coated with Eudragit L30D-55 at a coating level to a weight gain of 14 mg/capsule.

[625] Cohort: 8 x 10¹¹ cells of Prevotella Strain B 50329 or matching placebo are administered as capsules, once daily to subjects with psoriasis for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The capsule is a size 0 capsule that is enteric coated with Eudragit L30D-55 at a coating level to a weight gain of 14 mg/capsule.

[626] Cohort: 9.6 x 10¹¹ cells of Prevotella Strain B 50329 or matching placebo are administered as capsules, once daily to subjects with psoriasis for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The capsule is a size 0 capsule that is enteric coated with Eudragit L30D-55 at a coating level to a weight gain of 14 mg/capsule.

[627] Cohort: 12.8 x 10¹¹ cells of Prevotella Strain B 50329 or matching placebo are administered as capsules, once daily to subjects with psoriasis for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The capsule is a size 0 capsule that is enteric coated with Eudragit L30D-55 at a coating level to a weight gain of 14 mg/capsule.

Endpoints:

[628] The effects of Prevotella histicola Strain B on psoriasis can be optionally evaluated by one or more of the following criteria, e.g., at week 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 and/or 2, 4, and/or 24 weeks after treatment:

• Mean percentage change from baseline in the product of sPGA and BSA (total psoriasis severity index)

• Mean absolute and percentage change from baseline in the product of sPGA and BSA

• Mean absolute and percentage change from baseline in PASI

• Percentage of patients achieving at least a 50% improvement in PASI from baseline (PASI50)

• Time to achieve PASI50 • Percentage of patients achieving at least a 75% improvement in PASI from baseline (PASI75)

• Time to achieve PASI75

• Percentage of patients with a sPGA of clear (0) or very mild (1)

• Time to achieve sPGA of 0 or 1

• Percentage of patients with a sPGA of clear (0) or very mild (1) with a > 2 point improvement from baseline

• Absolute and Percentage change from baseline in total BSA affected by psoriasis

• Absolute and Percentage change from baseline in total PSI score

• Absolute and Percentage change from baseline in total DLQI (subjects aged > 18) or cDLQI (subjects aged < 18) score

• Percentage of subjects achieving an improvement from baseline of 4 or more in the DLQI

• Absolute and Percentage change from baseline in Pruritus-NRS

• Change from baseline in mNAPSI score

• Change from baseline in Psoriasis scalp severity index (PSSI) score

• EQ-5D (version 3L for subjects aged > 18; and version Y for subjects aged 12 to < 18)

• Treatment Satisfaction Questionnaire for Medication (TSQM)

• Hospital Anxiety and Depression Scale (HADS) (subjects aged > 18), or the Paediatric Index of Emotional Distress (PLED) (subjects aged 12 to < 18)

• Decrease in pain, e.g., as assessed by the SF-36 Bodily Pain Scale and/or the VAS Pain assessment

• Decrease in fatigue, e.g., as assessed by the vitality subscale of SF-36 and/or a fatigue VAS

[629] Efficacy assessments can include one or more of: the PASI score, the LSS, the National Psoriasis Foundation Psoriasis Score version of a static PGA, the percent of BSA involvement, the mNAPSI, the DLQI, the PSI (Psoriasis Symptom Inventory).

[630] Psoriasis Area and Severity Index Score: The PASI score can be assessed as described by Langley and Ellis (2004). The PASI is a physician assessment that combines the assessment of the severity of and area affected by psoriasis into a single score in the range 0 (no disease) to 72 (maximal disease). The PASI percentage response rates are efficacy endpoints (i.e., PASI-50, PASI-75, PASI-90, and PASI-100). For example, the percentage of participants who achieve a 75% or greater reduction in PASI score from baseline is represented by the PASI-75 value.

[631] Lesion Severity Score: The LSS is used to score the severity of psoriasis plaques (Patel and Tsui 2011). The dimensions of scaling, erythema, and plaque elevation are each scored on a scale from 0 to 4, and the total LSS is the numerical sum of the 3-dimensional scores observed at a single study visit.

[632] Physician ’s Global Assessment: The National Psoriasis Foundation Psoriasis Score version of a static PGA is calculated by averaging the total body erythema, induration, and desquamation scores (Feldman and Krueger 2005). Erythema, induration, and desquamation will be scored on a 6-point scale, ranging from 0 (clear) to 5 (severe): the total PGA score is defined as the average of the erythema, induration, and desquamation scores.

[633] Percent of Body Surface Area Involvement: The percent of BSA involvement can be estimated for each participant, where 1% is approximately the area of the participant’s handprint (Walsh et al 2013).

[634] Walsh and colleagues proposed the product of the PGA and the BSA involvement as a simple and effective alternative for measuring severity of psoriasis in clinical trials (Walsh et al 2013).

[635] Modified Nail Psoriasis Severity Index: The mNAPSI is a numeric, reproducible, objective, and simple tool for physicians to evaluate the severity of nail bed psoriasis and nail matrix psoriasis by area of involvement in the nail unit (Cassell et al 2007).

[636] Dermatology Life Quality Index: The DLQI is a patient reported outcomes instrument for assessing the impact of dermatologic conditions on patients’ quality of life (Finlay and Khan 1994).

[637] Psoriasis Symptom Inventory: The PSI is a patient reported outcomes instrument that is used to assess the severity of plaque psoriasis symptoms (Bushnell et al 2013). All symptoms (itch, redness, scaling, burning, cracking, stinging, flaking, and pain) are rated on a 5-point severity scale. The PSI demonstrated good construct validity and was sensitive to wi thin-subject change (p < 0.0001).

[638] Pain: Pain can be assessed by the SF-36 Bodily Pain Scale (SF-36 BPS) and the VAS Pain (Hawker et al 2011). [639] Fatigue: Consistent with a recent study of fatigue in psoriasis (Skoie et al 2017), fatigue can be assessed by the vitality subscale of the SF-36 (van der Heijden et al 2003) and a fatigue VAS (Wolfe 2004).

[640] In some embodiments, provided herein is a method of treating psoriasis comprising administering (e.g., orally administering) to a human subject a Prevotella histicola strain and/or a composition (e.g., a bacterial composition and/or a solid dosage form) comprising a strain of Prevotella histicola provided herein. In some embodiments, the human subject has a confirmed diagnosis of mild to moderate plaque-type psoriasis for at least 6 months involving no more than 10% of body surface area (BSA) (excluding the scalp). In some embodiments, the human subject has a minimum of 2 psoriatic lesions. In some embodiments, the subject has not received systemic non-biologic psoriasis therapy (methotrexate [MTX], steroids, cyclophosphamide) or psoralen plus ultraviolet A (PUVA)/ultraviolet A (UVA) phototherapy within 4 weeks prior to dosing. In some embodiments, subject has not received treatment with biologic agents within 12 months prior to first dose. In some embodiments, the subject is not continuing use of topical or oral pharmacologically active agents 2 weeks prior to the start of dosing. In some embodiments, the human subject has a documented diagnosis of plaque psoriasis for >6 months.

[641] In some embodiments, the human subject has had mild to moderate plaque psoriasis with plaque covering BSA of > 3% and < 10% and meet both of the following additional criteria: (i) PASI score of > 6 and < 15, and (ii) PGA score of 2 or 3.

[642] In some embodiments, the method decreases the PASI (Psoriasis Area and Severity Index) score in the subject, e.g., after 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s PASI score prior to the commencement of treatment).

[643] In some embodiments, the method increases a PASI percentage response rate (e.g., PASI-50, PASI-75, PASI-90, or PASI-100), e.g., as described herein. For example, the percentage of subjects who achieve a 75% or greater reduction in PASI score from baseline is represented by the PASI-75 value, e.g., after 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment.

[644] In some embodiments, the method decreases the LSS (Lesion Severity Score) in the subject, e.g., after 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s LSS prior to the commencement of treatment), e.g., as described herein. [645] In some embodiments, the method decreases the PGA (Physician’s Global Assessment) score in the subject, e.g., after 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s PGA score prior to the commencement of treatment), e.g., as described herein.

[646] In some embodiments, the method decreases the percent of BSA (Body Surface Area) involvement in the subject, e.g., after 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s percent involvement prior to the commencement of treatment), e.g., as described herein.

[647] In some embodiments, the method decreases the mNAPSI (Modified Nail Psoriasis Severity Index) score in the subject, e.g., after 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s mNAPSI score prior to the commencement of treatment), e.g., as described herein.

[648] In some embodiments, the method improves the DLQI (Dermatology Life Quality Index) score in the subject, e.g., after 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s DLQI score prior to the commencement of treatment), e.g., as described herein.

[649] In some embodiments, the method improves the PSI (Psoriasis Symptom Inventory) score in the subject, e.g., after 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s PSI score prior to the commencement of treatment), e.g., as described herein.

[650] In some embodiments, the method decreases pain in the subject, e.g., after 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s pain prior to the commencement of treatment), e.g., as described herein. For example, pain can be assessed by the SF-36 Bodily Pain Scale (SF-36 BPS) or the

VAS Pain.

[651] In some embodiments, the method decreases fatigue in the subject, e.g., after 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks of treatment (e.g., as compared to the subject’s fatigue prior to the commencement of treatment), e.g., as described herein.

References:

Bushnell DM, Martin ML, McCarrier K, et al. Validation of the Psoriasis Symptom Inventory (PSI), a patient-reported outcome measure to assess psoriasis symptom severity. J Dermatolog Treat. 2013;24(5):356-60. Cassell SE, Bieber JD, Rich P, et al. The modified Nail Psoriasis Severity Index: validation of an instrument to assess psoriatic nail involvement in patients with psoriatic arthritis. J Rheumatol. 2007 Jan;34(l): 123-9.

Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI): a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994;19:210-6.

Patel RV, Tsui CL. Evaluating psoriasis: a review of the assessments most commonly used in clinical trials. Psoriasis Forum. 2011;17(4):259-66. doi: 10.1177/247553031117a00403.

Skoie IM, Dalen I, Temowitz T, et al. Fatigue in psoriasis: a controlled study. Br J Dermatol. 2017;177(2):505-12. van der Heijden PG, van Buuren S, Fekkes M, et al. Unidimensionality and reliability under Mokken scaling of the Dutch language version of the SF-36. Qual Life Res. 2003;12: 189- 98.

Wolfe F. Fatigue assessments in rheumatoid arthritis: comparative performance of visual analog scales and longer fatigue questionnaires in 7760 patients. J Rheumatol. 2004;31(10): 1896-902. Example 3: Prevotella histicola Strain B Treatment for Atopic Dermatitis

[652] Prevotella histicola Strain B can be used for the treatment of atopic dermatitis, e.g., at the doses and dosing regimens provided herein. The atopic dermatitis can be mild, moderate, or severe atopic dermatitis. The atopic dermatitis can be mild to moderate atopic dermatitis.

Dose:

[653] Cohort: 8 x 1O¹⁰ cells of Prevotella Strain B 50329 or matching placebo are administered as a capsule, once daily to subjects with atopic dermatitis for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The capsule is a size 0 capsule that is enteric coated with Eudragit L30D-55 at a coating level to a weight gain of 14 mg/capsule.

[654] Cohort: 1.6 x 10¹¹ cells of Prevotella Strain B 50329 or matching placebo are administered as capsules, once daily to subjects with atopic dermatitis for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The capsule is a size 0 capsule that is enteric coated with Eudragit L30D-55 at a coating level to a weight gain of 14 mg/capsule.

[655] Cohort: 3.2 x 10¹¹ cells of Prevotella Strain B 50329 or matching placebo are administered as capsules, once daily to subjects with atopic dermatitis for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The capsule is a size 0 capsule that is enteric coated with Eudragit L30D-55 at a coating level to a weight gain of 14 mg/capsule.

[656] Cohort: 6.4 x 10¹¹ cells of Prevotella Strain B 50329 or matching placebo are administered as capsules, once daily to subjects with atopic dermatitis for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The capsule is a size 0 capsule that is enteric coated with Eudragit L30D-55 at a coating level to a weight gain of 14 mg/capsule.

[657] Cohort: 8 x 10¹¹ cells of Prevotella Strain B 50329 or matching placebo are administered as capsules, once daily to subjects with atopic dermatitis for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The capsule is a size 0 capsule that is enteric coated with Eudragit L30D-55 at a coating level to a weight gain of 14 mg/capsule.

[658] Cohort: 9.6 x 10¹¹ cells of Prevotella Strain B 50329 or matching placebo are administered as capsules, once daily to subjects with atopic dermatitis for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The capsule is a size 0 capsule that is enteric coated with Eudragit L30D-55 at a coating level to a weight gain of 14 mg/capsule.

[659] Cohort: 12.8 x 10¹¹ cells of Prevotella Strain B 50329 or matching placebo are administered as capsules, once daily to subjects with atopic dermatitis for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The capsule is a size 0 capsule that is enteric coated with Eudragit L30D-55 at a coating level to a weight gain of 14 mg/capsule.

Efficacy Assessments:

[660] The following endpoints can be evaluated at intervals prior to first administration of a bacterial composition described herein, and/or during administration (e.g., 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks) of a bacterial composition described herein and/or after administration has terminated (e.g., 2 and/or 4 and/or 24 weeks after termination):

EASI

[661] The Eczema Area and Severity Index (EASI) is a validated measure of eczema severity, which takes into account a combination of the body surface area affected, and the severity of erythema, oedema, excoriation and lichenification. The EASI score ranges from 0 - 72. (EASI, 2017) EASI-50 and EASI-75 responses are defined as at least 50% and 75% decrease from baseline EASI score respectively.

SCORAD

[662] The SCORing Atopic Dermatitis (SCORAD) is a clinical tool which is also used to assess the extent and severity of eczema, to assess treatment effects (ETFAD, 1993). As well as an investigator-rated area and disease intensity score, there is a subjective symptoms component which takes into account itch and sleeplessness using a visual analogue scale. The SCORAD score ranges from 0 - 103.

BSA

[663] The Body Surface Area (BSA) is a measure of the extent of atopic dermatitis at a given time. It is calculated by estimating the number of participant’s handprints of active atopic dermatitis are present; where one handprint (including digits) represents 1% body surface area.

IGA

[664] The Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA- AD) will be used to describe the overall appearance of lesions, at a given time-point (Simpson, 2020). There is a standardized grading system. In indeterminate cases, extent will be used to differentiate between scores - but otherwise extent is not used in the scoring system. The IGA score ranges from 0 (Clear) to 4 (Severe). IGA x BSA

[665] The product of the IGA and BSA provides a simple but useful measure of the extent and severity of eczema that is commonly used in the clinical trial setting.

DLQI questionnaire

[666] This is a validated patient reported outcomes instrument which asks 10 questions to assess how a participant’s skin disease has affected their quality of life over the past week (Finlay, 1994). The DLQI score ranges from 0 to 30.

POEM questionnaire

[667] The Patient-Orientated Eczema Measure (POEM) includes 7 questions about the participant’s atopic dermatitis. Each of the 7 questions is scored from 0 to 4, giving a POEM score range from 0 to 28.

Pruritus NRS questionnaire

[668] The Pruritus Numerical Rating Scale (Pruritus-NRS) is a 10-point scale for participants to rate both their average and worst itch that they have experienced over the previous 24 hours.

Example 4: Prevotella histicola Strain B for the Treatment of Psoriatic Arthritis

[669] Prevotella histicola Strain B can be used for the treatment of psoriatic arthritis (PsA), e.g., at the doses and dosing regimens provided herein. The psoriatic arthritis can be mild, moderate, or severe psoriatic arthritis. The psoriatic arthritis can be mild to moderate psoriatic arthritis.

Dose:

[670] Cohort: 8 x 1O¹⁰ cells of Prevotella Strain B 50329 or matching placebo are administered as capsules, once daily to subjects with psoriatic arthritis for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The capsule is a size 0 capsule that is enteric coated with Eudragit L30D-55 at a coating level to a weight gain of 14 mg/capsule.

[671] Cohort: 1.6 x 10¹¹ cells of Prevotella Strain B 50329 or matching placebo are administered as capsules or tablets, once daily to subjects with psoriatic arthritis for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The capsule is a size 0 capsule that is enteric coated with Eudragit L30D-55 at a coating level to a weight gain of 14 mg/capsule.

[672] Cohort: 3.2 x 10¹¹ cells of Prevotella Strain B 50329 or matching placebo are administered as capsules or tablets, once daily to subjects with psoriatic arthritis for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The capsule is a size 0 capsule that is enteric coated with Eudragit L30D-55 at a coating level to a weight gain of 14 mg/capsule.

[673] Cohort: 6.4 x 10¹¹ cells of Prevotella Strain B 50329 or matching placebo are administered as capsules or tablets, once daily to subjects with psoriatic arthritis for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The capsule is a size 0 capsule that is enteric coated with Eudragit L30D-55 at a coating level to a weight gain of 14 mg/capsule.

[674] Cohort: 8 x 10¹¹ cells of Prevotella Strain B 50329 or matching placebo are administered as capsules or tablets, once daily to subjects with psoriatic arthritis for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The capsule is a size 0 capsule that is enteric coated with Eudragit L30D-55 at a coating level to a weight gain of 14 mg/capsule.

[675] Cohort: 9.6 x 10¹¹ cells of Prevotella Strain B 50329 or matching placebo are administered as capsules or tablets, once daily to subjects with psoriatic arthritis for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The capsule is a size 0 capsule that is enteric coated with Eudragit L30D-55 at a coating level to a weight gain of 14 mg/capsule.

[676] Cohort: 12.8 x 10¹¹ cells of Prevotella Strain B 50329 or matching placebo are administered as capsules or tablets, once daily to subjects with psoriatic arthritis for 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. The capsule is a size 0 capsule that is enteric coated with Eudragit L30D-55 at a coating level to a weight gain of 14 mg/capsule.

Endpoints:

[677] The effects of Prevotella histicola Strain B on psoriatic arthritis can be evaluated by one or more of the following criteria e.g., at week 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 and/or 2, 4, and/or 24 weeks after treatment:

[678] Percentage of patients with an ACR20, ACR50, and/or ACR70 response: The ACR (American College of Rheumatology) is a standard criteria originally developed to measure the effectiveness of various arthritis medications or treatments in clinical trials for rheumatoid arthritis, but is also widely used in PsA. The ACR measures improvement in tender joint count (TJC) or swollen joint count (SJC), and improvement in at least 3 of the following 5 parameters: Patient Global Assessment (PtGA), Physician's Global Assessment of Disease Activity (PhGA), physical function (using HAQ-DI), visual analog pain scale, and acute phase reactant (using ESR or CRP). ACR 20/50/70 response is achieved if > 20%/> 50%/> 70% improvement in tender joint count (TJC) or swollen joint count (SJC) as well as a > 20%/> 50%/> 70% improvement in > 3 of the other 5 parameters.

[679] Change in Modified Psoriatic Arthritis Response Criteria (PsARC) score: Response is defined by improvement in at least 2 of the 4 following measures, one of which must be joint swelling or tenderness, and no worsening in any of the 4 measures: PtGA (patient global assessment) of articular disease (1-5) and PhGA (physician global assessment) of articular disease (1-5): improvement = decrease by at least one point on the 5 point scale, worsening = increase by at least one point on the 5 point scale. Joint pain/tenderness score and joint swelling score: improvement = decrease by 30%, worsening = increase by 30%.

[680] Dactylitis severity score: Changes from baseline in Dactylitis Severity Score at 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, or 56 weeks. Each digit with dactylitis is evaluated in a severity scale from 0 to 3 (0 = no dactylitis; 1 = mild dactylitis, 2 = moderate dactylitis, 3 = severe dactylitis). The total score is calculated as the sum of the individual digits dactylitis scores, ranging from a minimum 0 to a maximum of 60, with higher scores corresponding to worse severities.

[681] Clinical Disease Activity Index (CDAI): The Clinical Disease Activity Index (CD Al) is a composite index that is calculated as the sum of the: • 28 tender joint count (TJC), • 28 swollen joint count (SJC), • Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; • Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI: Remission: < 2.8 Low Disease Activity: > 2.8 and < 10 Moderate Disease Activity: > 10 and < 22 High Disease Activity: > 22.

[682] DAS28: Disease Activity Score (DAS): Changes in DAS28 (utilizing hsCRP) from baseline. The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score of 3.2 to 5.1 indicates moderate disease activity, a DAS28 score of 2.6 to 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.

[683] Maastricht Ankylosing Spondylitis Enthesis Score (MASES): The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses. See also L Heuft-Dorenbosch et al., Ann. Rheum. Dis. 62: 127-132 (2003).

[684] The effects of Prevotella histicola Strain B on psoriatic arthritis can be evaluated by one or more of the following criteria:

Tender and Swollen Joint Assessment, Psoriasis Area and Severity Index (PASI), Nail Psoriasis Severity Index (NAPSI), Modified Nail Psoriasis Severity Index (mNAPSI), Mander/Newcastle Enthesitis Index (MEI), Leeds Enthesitis Index (LEI), Spondyloarthritis Research Consortium of Canada (SPARCC), Maastricht Ankylosing Spondylitis Enthesis Score (MASES), Leeds Dactylitis Index (LDI), Patient Global for Psoriatic Arthritis, Dermatology Life Quality Index (DLQI), Psoriatic Arthritis Quality of Life (PsAQOL), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Psoriatic Arthritis Response Criteria (PsARC), Psoriatic Arthritis Joint Activity Index (PsAJAI), Disease Activity in Psoriatic Arthritis (DAPSA), and Composite Psoriatic Disease Activity Index (CPDAI). See Mease, Arthritis Care & Research 63:S64-S85 (2011).

[685] See also Gladman et al., J Rheumatology 34: 1159-1166 (2007).

Example 5: Capsules Comprising Prevotella histicola

[686] Capsules according to the following recipe in Table i were prepared: Table i: Prevotella histicola Capsule Composition

b Adjusted based on the potency of drug substance to ensure targeted strength.

The Prevotella histicola strain referred to above has been deposited as Prevotella histicola Strain B (NRRL accession number B 50329). The capsule was banded with an HPMC- based banding solution. The banded capsule was enteric coated with a poly(methacrylic acid-co-ethyl acrylate) copolymer.

Example 6: Capsule Comprising Prevotella histicola

[687] Capsules according to the following recipe in Table ii were prepared:

Table ii: Prevotella histicola Capsule Composition

a Swedish orange Vcap capsules

[688] The Prevotella histicola strain referred to above has been deposited as Prevotella histicola Strain B (NRRL accession number B 50329).

[689] The capsule was banded with an HPMC -based banding solution.

[690] The banded capsule was enteric coated with Eudragit L30-D55, a poly(methacrylic acid-co-ethyl acrylate) copolymer.

Example 7: Tablet Comprising Prevotella histicola

[691] As another example, the following recipe in Table iii is prepared.

Table iii: Prevotella histicola Tablet Composition

[692] The tablet is prepared as a 17.4mm x 7.1 mm tablet. The tablet is enteric coated. The tablet contains 3.2 x 10¹¹ TCC of Prevotella histicola Strain B (NRRL accession number B 50329). The Prevotella histicola strain referred to above has been deposited as Prevotella histicola Strain B (NRRL accession number B 50329).

Example 8: Scintigraphy Studies

Study Design

[693] To achieve maximum target engagement, enteric coated dosage forms of Prevotella Strain B 50329 (NRRL accession number B 50329) used in the clinic aim to ensure intact transit through the stomach (minimizing acid liability of the pharmaceutical agent), as well as start of release of pharmaceutical agent as proximal as possible in the small intestine.

[694] A phase 1, single-center, multi-part, open label, single dose, crossover study in healthy male volunteers using gamma-scintigraphy to evaluate the gastrointestinal behavior of Prevotella Strain B 50329 oral dosage forms, radiolabeled with ^99m-technetium- DTPA, was conducted. Each part of the study is to enroll up to 12 participants, and includes visualization of the stomach and intestinal transit of various dosage forms, as well as the point of release and dispersion characteristics of Prevotella Strain B 50329 pharmaceutical agent over a 12-hour post-ingestion period.

[695] Part 2 of the study is investigating single doses of lighter enteric-coated capsules such as EC2 capsules (coat level at 3 mg/cm²) containing Prevotella Strain B 50329, in both fed and fasted state. This part of the study aims to identify a coating thickness that not only protects the pharmaceutical agent from release in the stomach but results in consistent pharmaceutical agent release more proximally in the small intestine than ECI (coat level at 11 mg/cm²) capsules.

Safety Data

[696] In Part 2, there have been no TEAEs (Treatment-Emergent Adverse Events) after dosing the ECI or EC2 capsules.

Scintigraphy Data from Part 2

[697] In the first period of Part 2, the ECI capsule was dosed in a fasted state, acting as a reference treatment period.

[698] Subsequently, a lighter enteric-coated capsule (3 mg/cm² enteric coating- “EC2”) was dosed in both fasted and fed states. Preliminary data indicate the EC2 capsule starts to release its contents in the jejunum in the majority of participants (Table iv). There was no evidence of release in the stomach with either thickness of enteric coat, establishing that the EC2 coating maintained gastric protection.

[699] Mean time from gastric emptying to visualization of onset of release of the EC2 capsule was between approximately 24 (fed) to 34 minutes (fasted) which is > 50% shorter than the ECI capsule (Table v). The standard deviation of time to release was also less with the EC2 capsule than for the ECI capsule, indicating that onset of release was more consistent with the former.

[700] Small intestinal transit time was similar across treatment groups, supporting the fact that the reduced time from gastric emptying to visualization of onset of release with the EC2 capsule is associated with anatomically more proximal release in the small intestine.

Table iv: Site of Onset of Release of Drug Substance in Part 2

a. 1 out of the 12 participants missed dosing in this period due to positive urinary cotinine test b. 1 participant was withdrawn due to use of oral antibiotics. One was unable to dose due to intercurrent illness, unrelated to the study drug c. In 1 participant, gastric emptying of the capsule was not observed during the imaging period d. 3 subjects did not dose due to positive urine tests for possible drugs of abuse (two of these subjects were withdrawn; one other subject’s test was positive due to cocodamol therapy for back pain, unrelated to study drug)

Table v: Gastrointestinal Transit Tinies and Onset of Release in Part 2

a. 1 out of the 12 participants missed dosing in this period due to positive urinary cotinine test b. 1 participant was withdrawn due to use of oral antibiotics. One was unable to dose due to intercurrent illness, unrelated to study drug c. In 1 participant, gastric emptying of the capsule was not observed during the imaging period d. 3 subjects did not dose due to positive urine tests for possible drugs of abuse (two of these subjects were withdrawn; one other subject’s test was positive due to cocodamol therapy for back pain, unrelated to study drug

Overall Study Conclusions

[701] Capsules with EC2 coating show gastric integrity, but consistently display earlier release in the small intestine than capsule with EC2 coating, with the majority of capsules releasing in the jejunum.

[702] The consistent more proximal release of Prevotella Strain B 50329 in the small intestine with the EC2 capsule could be expected to be associated with greater rate of clinical efficacy than the ECI capsule.

Example 9: Site of onset of release correlates with coat thickness

[703] Size 0 capsules with enteric coating thicknesses of about 14, 31 or 60 mg weight gain per size 0 capsule were evaluated in scintigraphy studies. Capsules with the 14, 31, and 60 mg enteric coatings were administered to subjects in a fasted state; capsules with the 14 mg enteric coating were also administered to subjects in a fed state.

[704] The data are summarized in Table vi. Table vi. Site of start of release for enteric coated capsules.

[705] The median time from gastric emptying to start of release was:

• 60 mg EC fasted: 75 mins

• 31 mg fasted: 45 mins

• 14 mg EC fasted: 30 mins

• 14 mg EC fed: 20 mins

Example 10: Preparation of enteric coated capsules

Formulation Composition

Prevotella Strain B 50329 (NRRL accession number B 50329) formulation composition used in the study is provided in Table I.

Table I. Composition of Prevotella Strain B 50329 (NRRL accession number B 50329) size 0 capsule core formulation.

Equipment List

The equipment used in the study is summarized in Table II.

Table II. Equipment list for the manufacturing of Prevotella Strain B 50329 (NRRL accession number B 50329) enteric coated capsules.

Manufacturing Procedure

The workflow of the manufacturing process is 1- blending; 2- capsule filling; 3- capsule banding; 4- capsule coating.

1.1. Powder blending procedure and capsule filling

1.1.1. Blending Procedure

The blending process is summarized as follows:

1. Pass the powder through 35 mesh screen.

2. Pass silicon dioxide and mannitol through 20 mesh screen.

3. Blend sieved powder, silicon dioxide and mannitol at 250 RPM for 15 min.

4. Add magnesium stearate and mix for 3 min.

1.1.2. Capsule Filling

The capsule filling process is summarized as follows:

1. Set up the Profill 300 with size 0 HPMC (Hypromellose) Vcaps plus Swedish orange capsules.

2. Use the powder tray and powder spreader to fill the powder into the capsules.

Powder in the capsule was tamped 3 times to minimize the weight variations.

3. Final capsule fill weight is -300 mg per capsule.

4. Repeat the process to get a required number of capsules.

1.2. Capsule banding

1.2.1. Preparation of the Banding Solution The composition of the banding solution is listed in Table III.

Table III. Composition of the banding solution.

The preparation procedure of the banding solution is specified as follows:

1. Slowly add the hypromellose powder into 70% alcohol.

2. Homogenize at 6000 rpm for 5 min using high shear mixer.

3. Mix for additional 30 to 60 minutes to fully dissolve the hypromellose.

4. Sonicate the above solution to remove bubbles.

1.2.2. Banding procedure

The banding process is summarized as follows:

1. Turn on the banding machine.

2. Set up the following parameter: Wheel speed of 80, a chain speed of 20, and an application thickness of 0.5 mm.

3. Add the filled capsules into the capsule trays.

4. Add the banding solution into the solution tray.

5. Load the capsule trays, turn on the wheel and run the capsule tray through the banding area.

6. Check the completeness of the banding before the next capsule tray.

7. Air dry the banded capsules by leaving the capsules in trays for 20 minutes.

1.3. Capsule Coating for Early Release Formulation Evaluation

Preparation of Coating Solution

Composition of the enteric coating solution is listed in Table IV.

Table IV. Composition of the coating solution.

The following steps elaborate the process to prepare the coating solution.

1. Add talc and tri ethyl citrate into water for injection while mixing. Homogenize it at 6000 rpm for 5 min using high shear mixer.

2. Slowly add the above suspension into Eudragit L30D-55 suspension while mixing.

3. Mix for 30 min and pass through 60 mesh screen prior to use.

1.3.1. Capsule Coating

The following steps elaborate the coating process,

1. Weigh out 20 uncoated capsules and calculate the average capsule weight.

2. Load the uncoated capsules, warm up the pan coater and calibrate the spray rate.

3. Start the coating once the process parameters are in the range.

4. Take capsules out when an average capsule weight gain is 5, 9, 14, 19, 25, and/or 31 mg. (No curing is done for these samples.)

5. Conduct in-process curing with the exhaust temperature of 35 °C for 30 min when the weight gain is at 61 mg.

A summary of the coating parameters is shown in Table V.

Table V. Capsule coating process parameters.

A coating level of about 1 mg/cm² is about 5 mg per size 0 capsule; of about 1.7 mg/cm² is about 9 mg per size 0 capsule; of about 2.7 mg/cm² is about 14 mg per size 0 capsule; of about 3.7 mg/cm² is about 19 mg per size 0 capsule; of about 4.8 mg/cm² is about 25 mg per size 0 capsule; and of about 6 mg/cm² is about 31 mg per size 0 capsule.

Incorporation by Reference

[706] All publications patent applications mentioned herein are hereby incorporated by reference in their entirety as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. In case of conflict, the present application, including any definitions herein, will control.

Equivalents

[707] Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein. Such equivalents are intended to be encompassed by the following claims.

Claims

What is claimed is:

1. A method of treating a condition in a human subject comprising orally administering to the human subject a solid dosage form comprising a dose of about 1.6 x

10¹⁰ cells to about 16 x 10¹¹ cells of Prevotella histicola Strain B 50329 (NR.R.L accession number B 50329) bacteria, wherein the solid dosage form comprises an enteric coating; and wherein the enteric coating is at a coating level of between about 1 mg/cm² to about 6 mg/cm² per solid dosage form.

2. The method of claim 1, wherein the enteric coating is at a coating level of about 1 mg/cm²; about 1.7 mg/cm²; about 2.7 mg/cm²; about 3.7 mg/cm²; about 4.8 mg/cm²; or about 6 mg/cm² per solid dosage form.

3. The method of claim 1, wherein the enteric coating is at a coating level of about 2.7 mg/cm².

4. The method of any one of claims 1 to 3, wherein the condition comprises psoriasis, optionally wherein the psoriasis is mild, moderate, or severe psoriasis.

5. The method of any one of claims 1 to 3, wherein the condition comprises atopic dermatitis, optionally wherein the atopic dermatitis is mild, moderate, or severe atopic dermatitis.

6. The method of any one of claims 1 to 3, wherein the condition comprises psoriatic arthritis, optionally wherein the psoriatic arthritis is mild, moderate, or severe psoriatic arthritis.

7. The method of any one of claims 1 to 3, wherein the condition comprises an inflammatory disease.

8. The method of claim 7, the inflammatory disease is a Thl, Th2, or Thl7 inflammatory disease.

9. The method of any one of claims 1 to 8, wherein the dose comprises about 8 x IO¹⁰ cells to about 8 x 10¹¹ cells.

10. The method of claim 9, wherein the dose comprises about 8 x IO¹⁰ cells.

11. The method of claim 9, wherein the dose comprises 1.6 x 10¹¹ cells to about 6.4 x

10¹¹ cells.

12. The method of claim 9, wherein the dose comprises about 1.6 x 10¹¹ cells.

13. The method of claim 9, wherein the dose comprises about 3.2 x 10¹¹ cells.

14. The method of claim 9, wherein the dose comprises about 6.4 x 10¹¹ cells.

15. The method of any one of claims 1 to 9, wherein the solid dosage form comprises about 8 x IO¹⁰ cells per solid dosage form.

16. The method of any one of claims 1 to 15, wherein one solid dosage form is administered to the subject once daily.

17. The method of claim 15, wherein one solid dosage form is administered once daily, wherein the solid dose form comprises a dose of about 8 x IO¹⁰ total cells.

18. The method of any one of claims 1 to 17, wherein the one or more solid dosage forms are administered in combination with an additional therapy.

19. A method of treating psoriasis, optionally mild, moderate, or severe psoriasis, in a human subject comprising orally administering to the human subject a dose of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the dose is administered to the human subject for at least 8 weeks, wherein the dose is formulated in a solid dosage form, wherein the solid dosage form comprises about 3.2 x 10¹¹ total cells of the bacteria, optionally wherein the solid dosage form is a capsule; wherein the solid dosage form comprises an enteric coating; and wherein the enteric coating is at a coating level of about 2.7 mg/cm².

20. A method of treating psoriatic arthritis, optionally wherein the psoriatic arthritis is mild, moderate, or severe psoriatic arthritis, in a human subject comprising orally administering to the human subject a dose of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the dose is administered to the human subject for at least 8 weeks, wherein the dose is formulated in a solid dosage form, wherein the solid dosage form comprises about 3.2 x 10¹¹ total cells of the bacteria, optionally wherein the solid dosage form is a capsule; wherein the solid dosage form comprises an enteric coating; and wherein the enteric coating is at a coating level of about 2.7 mg/cm².

21. A method of treating atopic dermatitis, optionally mild, moderate, or severe atopic dermatitis, in a human subject comprising orally administering to the human subject a dose of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the dose is administered to the human subject for at least 8 weeks, wherein the dose is formulated in a solid dosage form, wherein the solid dosage form comprises about 3.2 x 10¹¹ total cells of the bacteria, optionally wherein the solid dosage form is optionally wherein the solid dosage form is a capsule; wherein the solid dosage form comprises an enteric coating; and wherein the enteric coating is at a coating level of about 2.7 mg/cm².

22. A method of treating psoriasis, optionally mild, moderate, or severe psoriasis, in a human subject comprising orally administering to the human subject a dose of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the dose is administered to the human subject for at least 8 weeks, wherein the dose is formulated in a solid dosage form, wherein the solid dosage form comprises about 8 x IO¹⁰ total cells of the bacteria, optionally wherein the solid dosage form is a capsule; wherein the solid dosage form comprises an enteric coating; and wherein the enteric coating is at a coating level of about 2.7 mg/cm².

23. A method of treating psoriatic arthritis, optionally mild, moderate, or severe psoriatic arthritis, in a human subject comprising orally administering to the human subject a dose of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the dose is administered to the human subject for at least 8 weeks, wherein the dose is formulated in a solid dosage form, wherein the solid dosage form comprises about 8 x IO¹⁰ total cells of the bacteria, optionally wherein the solid dosage form is a capsule; wherein the solid dosage form comprises an enteric coating; and wherein the enteric coating is at a coating level of about 2.7 mg/cm².

24. A method of treating atopic dermatitis, optionally mild, moderate, or severe atopic dermatitis, in a human subject comprising orally administering to the human subject a dose of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the dose is administered to the human subject for at least 8 weeks, wherein the dose is formulated in a solid dosage form, wherein the solid dosage form comprises about 8 x 10¹⁰ total cells of the bacteria, optionally wherein the solid dosage form is a capsule; wherein the solid dosage form comprises an enteric coating; and wherein the enteric coating is at a coating level of about 2.7 mg/cm².

25. A method of treating inflammation in a human subject comprising orally administering to the human subject a dose of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the dose is administered to the human subject for at least 8 weeks, wherein the dose is formulated in a solid dosage form, wherein the solid dosage form comprises about 3.2 x 10¹¹ total cells of the bacteria, optionally wherein the solid dosage form is a capsule; wherein the solid dosage form comprises an enteric coating; and wherein the enteric coating is at a coating level of about 2.7 mg/cm².

26. A method of treating inflammation in a human subject comprising orally administering to the human subject a dose of Prevotella histicola Strain B 50329 (NRRL accession number B 50329) bacteria, wherein the dose is administered to the human subject for at least 8 weeks, wherein the dose is formulated in a solid dosage form, wherein the solid dosage form comprises about 8 x IO¹⁰ total cells of the bacteria, optionally wherein the solid dosage form is a capsule; wherein the solid dosage form comprises an enteric coating; and wherein the enteric coating is at a coating level of about 2.7 mg/cm².

27. The method of any one of claims 1 to 26, wherein the enteric coating comprises a methacrylic acid ethyl acrylate (MAE) copolymer (1 : 1) such as Eudragit L copolymer, such as Eudragit L 30 D-55.

28. The method of any one of claims 1 to 27, wherein the solid dosage form comprises a capsule, optionally a size 0 capsule.