AU2016100499A4

AU2016100499A4 - Yeast-containing compositions for gastrointestinal health

Info

Publication number: AU2016100499A4
Application number: AU2016100499A
Authority: AU
Inventors: Samantha Coulson; Sean HALL; Luis Vitetta
Original assignee: Pharm A Care Laboratories Pty Ltd
Current assignee: Pharm A Care Laboratories Pty Ltd
Priority date: 2015-05-01
Filing date: 2016-05-02
Publication date: 2016-06-02
Anticipated expiration: 2024-05-02

Abstract

Abstract Provided herein are compositions for promoting and supporting gastrointestinal health and/or immunological function, for improving or treating irritable bowel syndrome and for treating diarrhoea, constipation or a mixture of both diarrhoea and constipation, the compositions comprising a yeast strain of the genus Saccharomyces, glutamine and a source of fibre. Also provided are methods for promoting and supporting gastrointestinal health and/or immunological function, for improving or treating irritable bowel syndrome, for treating diarrhoea and for treating constipation, comprising administering to a subject a composition of the present disclosure.

Description

Yeast-containing compositions for gastrointestinal health

Field of the Art [001] The present disclosure relates generally to compositions comprising a yeast strain of the genus Saccharomyces, glutamine and a source of fibre, and uses of such compositions for promoting and supporting gastrointestinal health and/or immunological function.

Background [002] The digestive system serves in the digestion and absorption of nutrients both macronutrients (for example proteins, lipids and carbohydrates) and micronutrients (for example vitamins and minerals), the removal of catabolic / metabolic waste products from the gastrointestinal tract, and in the subsequent maintenance of metabolic balance in the gastrointestinal tract that is conducive to maintaining homeostasis. Gastrointestinal inflammatory diseases such as, ulcerative colitis, Crohn's disease, irritable bowel syndrome and refractor}' coeliac disease as well as gastrointestinal conditions such as diarrhoea and constipation that result from poor gastrointestinal health or adverse nutritional and / or environmental triggers.

[003] Accordingly, there is a need for compositions and methods that support gastrointestinal health and/or immunological function that counteract a predisposition to adverse pro-inflammatory stimuli.

[004] The present inventors have found that compositions comprising a combination of a yeast, strain of the genus Saccharomyces, glutamine and a source of fibre support, gastrointestinal health and/or balanced immunological pro-inflammatory / anti-inflammatory functions.

Summary of the Disclosure [005] In a first aspect, the present disclosure provides a composition comprising a yeast strain of the genus Saccharomyces, glutamine and a source of fibre.

[006] Typically the composition is for promoting and supporting gastrointestinal health and/or balanced immunological pro-inflammatory / anti-inflammatory functions in a subject.

[007] In one embodiment the composition may further comprise one or more polyphenolic flavonoids and/or a peppermint extract. Typically the peppermint extract is a peppermint leaf extract. The peppermint leaf extract may be in an amount of from about 1 mg to about 1000 mg equiv. dry peppermint / 6 g composition. In one embodiment the peppermint leaf extract is in an amount of about 100 mg equiv. dry peppermint / 6 g composition.

[008] Typically the yeast comprises Saccharomyces cerevisiae. In an exemplary embodiment the Saccharomyces cerevisiae is S cerevisiae spp. houlardii. The one or more yeast from the genus Saccharomyces may be present in the composition in an amount of from about 1 billion to about 50 billion CPU / 6 g composition. In one embodiment the one or more yeast from the genus Saccharomyces is present in the composition in an amount of about 5 billion CFU / 6 g composition.

[009] Typically the glutamine is L-glutamine. The glutamine in the composition may be in an amount of from about 0.5 g to about 3.5 g / 6 g composition. In one embodiment the glutamine in the composition is in an amount of about 2 g / 6 g composition.

[0010] In some embodiments the source of fibre provides a soluble fibre, for example comprising a polysaccharide. In an exemplary embodiment, the source of fibre comprises an arabinogalaetan. The arabinogaiactan may be derived from a tree of the Larix genus. Typically the tree of the Larix genus is Larix occidentalis. The arabinogaiactan in the composition may be in an amount of from about 0.5 g to about 3.5 g / 6 g composition. In one embodiment the arabinogaiactan in the composition is in an amount of about 2 g / 6 g composition.

[0011] In some embodiments the composition further comprises at least one sweetener. The at least one sweetener may be a natural sweetener. Typically the natural sweetener is stevia. The stevia may be in an amount of from about 1 mg to about 1000 mg / 6 g composition. In one embodiment the stevia is in an amount of about 11 mg / 6 g composition.

[0012] In another embodiment the composition further comprises silica. Typically the silica is colloidal anhydrous silica. The silica may be in an amount of from about 1 mg to about 1000 mg / 6g composition. In one embodiment the silica is in an amount of about 100 mg / 6 g composition.

[0013] In another embodiment the composition further comprises cocoa powder. The cocoa powder may be in an amount of from about 10 mg to about 1000 mg / 6 g composition. In one embodiment the cocoa powder is in an amount of about 465 mg / 6 g composition.

[0014] In an exemplary embodiment the composition comprises Saccharomyces cerevisiae spp. boulardii, L-glutamine, arabinogalactan and peppermint leaf extract.

[0015] The composition may consist essentially of a yeast strain of the genus Saccharomyces, glutamine and a source of fibre.

[0016] In a second aspect the present disclosure provides a composition consisting essentially of Saccharomyces cerevisiae spp. houlardii, L-glutamine, arabinogalactan and peppermint leaf extract.

[0017] The composition of the first or second aspect may be provided in a dried form, wherein the composition is mixed with an aqueous medium prior to oral administration. Typically the dried form is a powder form. Typically the aqueous medium is water.

[0018] In a third aspect, the present disclosure provides a concentrate for use in preparing a solution or suspension, wherein the concentrate comprises a yeast strain of the genus Saccharomyces, glutamine and a source of fibre, and optionally peppermint leaf extract, wherein the concentrate is mixed with an aqueous medium prior to use to produce a liquid composition for oral administration.

[0019] The concentrate may comprise or consist essentially of a composition of the first or second aspect.

[0020] The concentrate may be, for example, in the form of a powder, granules, tablets, capsules or a gel. In a particular embodiment, the concentrate is in dried form, typically a powder. In particular embodiments the aqueous medium is water.

[0021] In a fourth aspect, the present disclosure provides a method of promoting and/or supporting gastrointestinal health and/or immunological function in a subject, the method comprising administering to the subject a composition of the first or second aspect.

[0022] In a fifth aspect, the present disclosure provides a method for treating irritable bowel syndrome in a subject, the method comprising administering to the subject a composition of the fi rst or second aspect.

[0023] In a sixth aspect, the present disclosure provides a method for treating diarrhoea in a subject, the method comprising administering to the subject a composition of the first or second aspect.

[0024] In a seventh aspect, the present disclosure provides a method for treating constipation in a subject, the method comprising administering to the subject a composition of the first or second aspect.

[0025] Also provided herein is the use of a yeast strain of the genus Saccharomyces, glutamine and arabinogalactan in the manufacture of a medicament for promoting, supporting and/or maintaining gastrointestinal health and/or immunological function, or for treating irritable bowel syndrome, diarrhoea or constipation.

Detailed Description [0026] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art to which the disclosure belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present disclosure, typical methods and materials are described.

[0027] In the context of this specification, the terms "a" and "an" are used herein to refer to one or to more than one (i.e. to at least one) of the grammatical object of the article. By way of example, "an element" means one element or more than one element.

[0028] In the context of this specification, the term "about,” is understood to refer to a range of numbers that a person of skill in the art would consider equivalent to the recited value in the context of achieving the same function or result, [0029] Throughout this specification and the claims which follow, unless the context requires otherwise, the word "comprise", and variations such as "comprises" or "comprising”, will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps.

[0030] As used herein, the term “source of fibre” refers to any component or ingredient of a composition that contains, comprises or consists of fibre of dietary or nutritional benefit to the consumer of the composition. The source of fibre may itself contain or comprise constituents or activities other than fibre, and indeed may be included in the composition other than to provide fibre.

[0031] In the context of this specification, "food", "foods”, "beverage” or "beverages” includes but is not limited to health foods, functional foods and foods for specified health use.

When such food or beverage of the present disclosure is used for subjects other than humans, the term can be used to include a feedstuff.

[0032] In the context of this specification, the term “prebiotic” is to be given its broadest construction and is understood to refer to any noil-digestible substance that stimulates the growth and/or activity of bacteria in the digestive system.

[0033] The term "subject" as used herein refers to any mammal, including, but not limited to, livestock and other farm animals (such as cattle, goats, sheep, horses, pigs and chickens), performance animals (such as racehorses), companion animals (such as cats and dogs), laboratory test animals and humans. Typically the subject is a human.

[0034] As used herein, the term "effective amount" refers to an amount of a composition that is sufficient to effect one or more beneficial or desired outcomes. An “effective amount” can be provided in one or more administrations. The exact amount required will vary depending on factors such as the identity and number of individual probiotic strains employed in the composition, the subject being treated, the nature and degree of any disease or condition suffered by the subject and the age and general health of the subject, and the form in which the composition is administered. For any given case, an appropriate “effective amount” may be determined by one of ordinary skill in the art using only routine experimentation.

[0035] In the context of this specification, the terms “support” and “supporting” and variations thereof as used herein refer to the ability of a composition of the present disclosure to maintain the health, either directly or indirectly, of the gastrointestinal tract and/or the immune system, or otherwise prevent, hinder, retard, or reverse the deterioration in the health of a subject in any way whatsoever. Thus the terms “support” and “supporting” and the like are to be considered in their broadest context, [0036] In the context of this specification, the terms "promote" and "promoting" and variations thereof as used herein refer to the ability of a composition of the present disclosure to achieve or assist in achieving a benefit, either directly or indirectly, in relation to the health of the gastrointestinal tract, the health of the immune system and/or diseases associated therewith; or to improve the ability to achieve or assist in achieving a measurable benefit, either directly or indirectly, in relation the health of the gastrointestinal tract the health of the immune system and/or diseases associated therewith. Thus the terms "promote” and "promoting" and the like are to be considered in their broadest context.

[0037] As used herein the terms "treating", “treatment” and the like refer to any and all applications which remedy, or otherwise hinder, retard, or reverse the progression of, a condition or at least one symptom of a condition, including reducing the severity of the condition. Thus, treatment does not necessarily imply that a subject is treated until complete elimination of, or recovery' from, the condition.

[0038] The term "optionally" is used herein to mean that the subsequently described feature may or may not be present or that the subsequently described event or circumstance may or may not occur. Hence the specification will be understood to include and encompass embodiments in which the feature is present and embodiments in which the feature is not present, and embodiments in which the event or circumstance occurs as well as embodiments in which it does not.

[0039] Embodiments of the present disclosure provide compositions comprising a yeast strain of the genus Saccharomyces, glutamine and arabinogalactan. Typically the compositions are for use in promoting and supporting gastrointestinal health and/or immunological function.

[0040] The compositions of the disclosure are therefore useful for managing conditions and disorders that are associated with poor gastrointestinal health and/or immunological function, such as irritable bowel syndrome, diarrhoea and related conditions (e.g., constipation).

[0041] In some embodiments the compositions may promote a healthy immune system thereby reducing the risk of autoimmune disease, reducing inflammation, and promoting the health of the gastrointestinal tract thereby promoting healthy digestion and absorption of nutrients in a subject. The compositions may generally relieve gastrointestinal discomfort.

[0042] In other embodiments the compositions may promote the health of a subject by supporting the immune system after periods of physical stress such as injury, illness, trauma or strenuous exercise.

[0043] Whilst not wishing to be bound by theory', it is suggested that the yeast strain assists with the treatment of symptoms of diarrhoea and constipation, supporting a healthy gastrointestinal microbial and intestinal epithelium profile. Arabinogalactan and bioactive polyphenolic flavonoids have favourable immune modulating properties that may support healthy immune function via various mechanisms. Arabinogalactan also functions as a prebiotic supporting the growth, activity and health of the gut commensal bacterial cohort. Again, without wishing to be bound by theory, the inventors suggest that compositions according to the present disclosure may also generally support and favour healthy gastrointestinal homeostasis and permeability, for example as evidenced by intestinal epithelial cell tight junction health.

[0044] The compositions of the present disclosure may comprise any one or more yeast strain from the genus Saccharomyces. The yeast may be present in the composition as specially selected species as a culture concentrate or as part of a multiple species blend with a variety of excipients. The yeast strain of the genus Saccharomyces may include one or more strain of the species Saccharomyces cerevisiae, Saccharomyces bayanus, Saccharomyces boulardii, Saccharomyces bulderi, Saccharomyces cariocanus, Saccharomyces cariocus, , Saccharomyces chevalieri, Saccharomyces dairenensis, Saccharomyces ellipsoideus,

Saccharomyces eubayanus, Saccharomyces exiguus, Saccharomyces florentinus,

Saccharomyces kluyveri, Saccharomyces mariiniae, Saccharomyces monacensis,

Saccharomyces norbensis, Saccharomyces paradoxus, Saccharomyces pastorianus,

Saccharomyces spencerorum, Saccharomyces turicensis, Saccharomyces unisporus,

Saccharomyces uvarum or Saccharomyces zonatus. In a particular embodiment the yeast strain a is Saccharomyces cerevisiae, such as Saccharomyces cerevisiae spp. boulardii.

[0045] The amount of the yeast strain of the genus Saccharomyces included in compositions disclosed herein may depend on a variety of factors including the identity and number of the strain employed, the presence (and identity) of any additional yeast or other microbial strains, and the form in which the composition is to be administered. By way of example only, the amount of the yeast strain of the genus Saccharomyces present in a single 5 gram dose of a composition disclosed herein may be from about 1 billion to about 50 billion cfu / 5 or 6 g composition, or more typically between about 2 billion to about 10 billion cfu / 5 or 6 g composition. In particular embodiments, the composition may comprise about 2.5 billion cfu / 6 g composition, 3.0 billion cfu / 6 g composition, 3.5 billion cfu / 6 g composition, 4.0 billion cfu / 6 g composition, 4.5 billion cfu / 6 g composition, 5 billion cfu / 6 g composition, 5.5 billion cfu / 6 g composition, 6 billion cfu / 6g composition, 6.5 billion cfu / 6 g composition, 7 billion cfu / 6 g composition, 7.5 billion cfu / 6 g composition, 8 billion cfu / 6 g composition, 8.5 billion cfu / 6 g composition, 9 billion cfu / 6 g composition or 9.5 billion cfu / 6 g composition of the yeast strain of the genus Saccharomyces. In an exemplary embodiment, the strain is present in an amount of about 5 billion cfu / 6 g composition.

[0046] Also contemplated herein is the inclusion in compositions of the disclosure of one or more probiotic bacterial strains. Suitable probiotic bacteria may be selected from Lactobacillus sp., Lactococcus sp., Streptococcus sp. and Bifidobacterium, sp. Exemplary strains include, but are not limited to, Lactobacillus rhamnosus, Lactobacillus plantarum, Lactobacillus bulgaricus, Lactobacillus gasseri, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus easel, Lactobacillus acidophilus, Lactobacillus fermentum, Lactobacillus salvor ius, Lactococcus lactis, Streptococcus thermophilus, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium animal is subsp. lactis (B. lactis), Bifidobacterium animal is subsp. animal is (B, animal is). Bifidobacterium infantis, Bifidobacterium longum and Bifidobacterium pseudocatemdatum, [0047] Also contemplated by the present disclosure are variants of the yeast strains described herein. As used herein, the term "variant" refers to both naturally occurring and specifically developed variants or mutants. Variants may or may not have the same identifying biological characteristics of the specific strains exemplified herein, provided they share similar advantageous properties in terms of their ability to be used in accordance with the present disclosure. Illustrative examples of suitable methods for preparing variants of the yeast strains exemplified herein include, but are not limited to, culturing under selective growth conditions, gene integration techniques such as those mediated by insertional elements or transposons or by homologous recombination, other recombinant DNA techniques for modifying, inserting, deleting, activating or silencing genes, intraspecific protoplast fusion, mutagenesis by irradiation with ultraviolet light or X-rays, or by treatment with a chemical mutagen such as nitrosoguanidine, methylmethane sulfonate, nitrogen mustard and the like, and bacteriophage-mediated transduction. Suitable and applicable methods are well known in the art and are described, for example, in J. H. Miller, Experiments in Molecular Genetics, Cold Spring Harbor Laboratory Press, Cold Spring Harbor, N.Y. (1972); J. H. Miller, A Short Course in Bacterial Genetics, Cold Spring Harbor Laboratory Press, Cold Spring Harbor, N.Y. (1992); and J. Sambrook, D. Russell, Molecular Cloning: A Laboratory Manual, 3rd ed., Cold Spring Harbor Laboratory Press, Cold Spring Harbor, N.Y. (2001), inter alia.

[0048] Also encompassed by the term “variant” as used herein are yeast strains phylogenetically closely related to strains disclosed herein and strains possessing substantial sequence identity with the strains disclosed herein at one or more phylogenetically informative markers such as rRNA genes, elongation and initiation factor genes, RNA polymerase subunit genes, DNA gyrase genes, heat shock protein genes and recA genes. For example, the 16S rRNA genes of a “variant” strain as contemplated herein may share about 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98% or 99% sequence identity with a strain disclosed herein.

[0049] The glutamine may be present in the composition in the form of a salt or derivative. Typically the glutamine is L-glutamine. In accordance with particular embodiments the amount of glutamine present in the composition may be between about 0,5 g to about 3.5 g / 5 or 6 g composition. In particular embodiments, the composition may comprise about 1.0 g / 6 g composition, 1.25 g / 6 g composition, 1,5 g / 6 g composition, 1.75 g / 6 g composition, 2.0 g / 6 g composition, 2.25 g / 6 g composition, 2.5 g / 6 g composition, 2.75 g / 6 g composition, 3.0 g / 6g composition or 3.25 g / 6g composition of glutamine. In an exemplary' embodiment, the composition comprises about 2 g L-glutamine / 6g composition.

[0050] The compositions of the present disclosure comprise a source of fibre. The source of fibre may comprise soluble fibre, insoluble fibre, or a combination of both soluble and insoluble fibre. Suitable sources of soluble fibre include, but are not limited to, psyllium, dextrins, fructans, oligosaccharides (e.g. inulins) and polysaccharides. Exemplary' polysaccharides include arabinogalactans and resistant starches. Arabinogalactans are complex proteoglycans of arabinose and galactose, often classified as plant or microbial arabinogalactan. An exemplary' arabinogalactan is Larch arabinogalactan. The resistant starch may be an RSI, RS2, RS3 or RS4 resistant starch. An exemplary resistant starch is Hi-Maize resistant starch, [0051] In an exemplary embodiment, the source of fibre is an arabinogalactan. The arabinogalactan may be a plant arabinogalactan and/or a microbial arabinogalactan. Typically the arabinogalactan is a plant arabinogalactan derived from a tree of the Larix genus, however those skilled in the art will appreciate that any arabinogalactan may be used. In some embodiments the tree of the Larix genus is Larix occidentalis. The arabinogalactan may be mixed with bioactive flavonoids, such as polyphenolic bioactive flavonoids and used in the compositi on in the form of mixture, for example ResistAid™.

[0052] In accordance with particular embodiments the amount of arabinogalactan, optionally mixed with one or more bioactive flavonoids, present in the composition may be between about 0.5 g to about 3.5 g / 5 or 6 g composition. In particular embodiments, the composition may comprise about 1.0 g / 6 g composition, 1.25 g / 6 g composition, 1.5 g / 6 g composition, 1.75 g / 6 g composition, 2.0 g / 6 g composition, 2.25 g / 6 g composition, 2.5 g / 6 g composition, 2.75 g / 6 g composition, 3.0 g / 6 g composition or 3.25 g / 6 g composition of arabinogalactan, In an exemplary embodiment, the composition comprises about 2 g ResistAid™ / 6g composition.

[0053] In some embodiments the composition further comprises a peppermint extract. Typically the peppermint extract is a peppermint leaf extract. In accordance with particular embodiments the amount of peppermint leaf extract present in the composition may be between about 1 mg to about 1000 mg equiv. dry peppermint / 5 or 6 g composition. In accordance with particular embodiments the amount of peppermint leaf extract present in the composition may be about 25 mg equiv. dry' peppermint / 6 g, 50 mg equiv. dry peppermint / 6g composition, 100 mg equiv. dry peppermint / 6g composition, 150 mg equiv. dry peppermint / 6 g composition, 200 mg equiv. dry peppermint / 6 g composition, 250 mg equiv. dry? peppermint / 6 g composition, 300 mg equiv. dry peppermint / 6 g composition, 350 mg equiv. dry peppermint / 6 g composition, 400 mg equiv. dry peppermint / 6 g composition, 450 mg equiv. dry peppermint / 6 g composition, 500 mg equiv, dry peppermint / 6 g composition, 550 mg equiv. dry' peppermint / 6 g composition, 600 mg equiv. dry peppermint / 6 g composition, 650 mg equiv. dry peppermint / 6 g composition, 700 mg equiv. dry peppermint / 6 g composition, 750 mg equiv. dry peppermint / 6 g composition, 800 mg equiv. dry peppermint / 6 g composition, 850 mg equiv. dry' peppermint / 6 g composition, 900 mg equiv, dry peppermint / 6 g composition or 950 mg equiv, dry peppermint / 6 g composition. In an exemplary embodiment, the composition comprises about 100 mg peppermint leaf extract / 6g composition.

[0054] In some embodiments the composition further comprises at least one sweetener. The at least one sweetener may be a natural sweetener. Typically the natural sweetener is stevia. The stevia may be in an amount of from about 1 mg to about 1000 mg / 5 or 6 g composition. In accordance with particular embodiments the amount of stevia present in the composition may be between about 1 mg to about 50 mg / 6g composition. In particular embodiments, the composition may comprise between about 1 mg to about 20 mg / 6 g composition of stevia. In particular embodiments, the composition may comprise about, 2 mg 16 g composition, 3 mg / 6 g composition, 4 mg / 6 g composition, 5 mg / 6 g composition, 6 mg / 6 g composition, 7 mg / 6 g composition, 8 mg / 6 g composition, 9 mg / 6 g composition, 10 mg /6 g composition, 11 mg / 6g composition, 12 mg / 6g composition, 13 mg / 6g composition, 14 mg / 6g composition, 15 mg / 6g composition, 16 mg / 6g composition, 17 mg / 6 g composition, 18 mg / 6 g composition, or 19 mg / 6 g composition of stevia.

[0055] In another embodiment the composition further comprises silica. Typically the silica is colloidal anhydrous silica. The silica may be in an amount of from about 1 mg to about 1000 mg / 5 or 6 g composition. In accordance with particular embodiments the amount of silica present in the composition may be between about 50 mg to about 300 mg / 6 g composition. In particular embodiments, the composition may comprise about 75 mg / 6 g composition, 100 mg / 6 g composition, 125 mg / 6 g composition, 150 mg / 6 g composition, 175 mg / 6 g composition, 200 mg / 6 g composition, 225 mg / 6 g composition, 250 mg / 6 g composition or 275 mg / 6 g composition of silica.

[0056] In another embodiment the composition further comprises cocoa powder. The cocoa powder may be in an amount of from about 10 mg to about 1000 mg / 5 or 6 g composition. In accordance with particular embodiments the amount of cocoa powder present in the composition may be between about 200 mg to about 600 mg / 5 or 6 g composition. In particular embodiments, the composition may comprise about 250 mg / 6g composition, 300 mg / 6 g composition, 350 mg / 6 g composition, 400 mg / 6 g composition, 450 mg / 6 g composition, 500 mg / 6 g composition or 550 mg / 6 g composition of cocoa powder.

[0057] In a particular embodiment the composition comprises Saccharomyces cerevisiae spp. boulardii, L-glutamine, arabinogalactan and peppermint leaf extract.

[0058] In a particular embodiment the composition consists essentially of Saccharomyces cerevisiae spp. boulardii, L-glutamine, arabinogalactan and peppermint leaf extract.

[0059] In some embodiments, compositions of the present disclosure may further comprise one or more additional prebiotic components, vitamins and/or minerals. Suitable prebiotics include polydextrose, inulin, fructooligosaccharides (FOS), xylooligosaccharides (XOS), galactooligosaccharides (GOS), mannan oligosaccharides, protein-based green lipped mussel extract, and various prebiotic-containing foods such as raw onion, raw leek, raw7 chickory root and raw7 artichoke. The vitamins and minerals may be selected from, but not limited to: vitamins A, Bt, B2, B3, B5, B6, B9, B]?, C, D, E and calcium, chromium, copper, fluorine, iodine, iron, magnesium, manganese, molybdenum, phosphorus, and selenium, [0060] Compositions of the present disclosure may further comprise one or more amino acids. The antino acids may be selected from, but are not limited to: alanine, arginine, aspartic acid, cystine, glycine, histidine, leucine, lysine, methionine, phenylalanine, proline, serine, threonine, tryptophan and tyrosine.

[0061] Compositions of the present disclosure may further comprise one or more antioxidants or sources of antioxidant activity. Exemplary antioxidants may be water soluble or lipid soluble and include, but are not limited to, carotenes (e.g. beta-carotene, lycopene, lutein, zeaxanthin), flavonoids, tocopherols, tocotrienols, polyphenols (e.g. resveratrol, catechins), glutathione, anthocyanins, vitamins (e.g. vitamin A, vitamin C, vitamin E) and their derivatives, coenzymes (e.g. coenzyme Q10), and minerals (e.g. selenium, copper, zinc, manganese). Suitable sources of antioxidant activity include various plant extracts, herbal extracts and spices, as will be readily appreciated by those skilled in the art.

[0062] The compositions may additionally include any suitable additives, carriers, additional therapeutic agents, bioavailability enhancers, side-effect suppressing components, diluents, buffers, flavouring agents, colouring agents, binders, preservatives or other ingredients that are not detrimental to the efficacy of the composition.

[0063] In particular embodiments, the composition may be gluten free and dairy' free, and suitable for ingestion by vegetarians.

[0064] Compositions of the invention can be readily manufactured by those skilled in the art using known techniques and processes. For example, the yeast can be grown in standardized media, until a predetermined cfu/g concentration is reached. The bulk material can then be drained from the reactor and dried by spray drying, lyophilization, or flatbed oven drying. The dried bacterial material can then be blended with the carrier medium and the resulting mixture can be pressed into tablets, filled into foil pouches as a granular solid, or introduced into gelatin capsules as a particulate material.

[0065] Compositions of the present disclosure may be suitably formulated for oral administration, and may be prepared according to conventional methods well known in the pharmaceutical and nutraceutical industries, such as those described in Remington’s Pharmaceutical Handbook (Mack Publishing Co., NY, USA) using suitable excipients, diluents and fillers.

[0066] Compositions may be dried to form, for example, a powder, granules, capsules or tablets. For oral administration, the composition may then be mixed with a suitable volume of an aqueous medium, typically with agitation, to dissolve the components, or produce a suspension, suitable for ingestion. Thus, the compositions may be provided to a. user in a powder form, which powder may then be added by the user to any type of aqueous medium (for example water or fruit juice) and consumed there after. Alternatively, the composition may be provided as a beverage, pre-mixed with an aqueous medium such as water. In another embodiment the compositions may be added in powder form by the user to any type to a food product (for example, yoghurt) and consumed there after. In another embodiment, the compositions may simply be consumed as a powder in the absence of a drink or additional food product.

[0067] By way of example, a 5 g or 6 g dose of a composition of the present disclosure may be added to 250 rnL water or other fluid and stirred immediately prior to administration to a subject.

[0068] Compositions of the present disclosure may be conveniently incorporated in a variety of food and/or beverage products, nutraceutical products, probiotic supplements, food additives, pharmaceuticals and over-the-counter formulations. The food or food additive may be a solid form such as a powder, or a liquid form. Specific examples of the types of beverages or foods include, but are not limited to water-based, milk-based, yoghurt-based, other dairy-based, milk-substitute based such as soy milk or oat milk, or juice-based beverages, water, soft drinks, carbonated drinks, and nutritional beverages, (including a concentrated stock solution of a beverage and a dry powder for preparation of such a beverage); baked products such as crackers, breads, muffins, rolls, bagels, biscuits, cereals, bars such as muesli bars, health food bars and the like, dressings, sauces, custards, yoghurts, puddings, pre-packaged frozen meals, soups and confectioneries.

[0069] Also provided herein are methods for promoting and supporting gastrointestinal health and/or balanced and favourable immunological functions in a subject, improving and/or treating irritable bowel syndrome in a subject, improving and/or treating diarrhoea in a subject, and improving and/or treating constipation in a subject, comprising administering to the subject a composition of the present disclosure.

[0070] Also provided herein are uses of compositions comprising one or more yeast from the genus Saccharomyces, glutamine and a source of fibre in the manufacture of a medicament for promoting and supporting gastrointestinal health and/or immunological function in a subject, improving and/or treating irritable bowel syndrome in a subject, improving and/or treating diarrhoea in a subject, and improving and/or treating constipation in a subject, [0071] For the various circumstances in which a composition of the present disclosure may be administered, those skilled in the art will appreciate that the amount of the consumed, and the number of discreet consumptions per unit time will vary depending on the actual use to which the composition is put, the condition of the subject who will consume the beverage, the subject's age, sex, weight and general health. By way of example, a 5 g or 6 g dose of a composition of the present disclosure may be added ίο 250 mL water and stirred immediately prior to administration. Typically, several divided doses may be administered in half hourly or hourly, daily or at other suitable time intervals, and/or the dose may be proportionally reduced or increased as indicated by the exigencies of the situation.

[0072] By way of example only, a suitable dose of a beverage prepared by the addition of 5 g or 6 g of composition to 250 mL of water may be 250 mL once or twice a day (as required). Those skilled in the art will appreciate that the amount of composition to be reconstituted in water, the amount of water, the amount of beverage to be consumed and the frequency of consumption may be varied according to requirements of the individual subject. The skilled addressee can readily determine suitable dosage regimes. A broad range of doses may be applicable. Dosage regimens may be adjusted to provide the optimum response. Those skilled in the art will appreciate that the exact amounts and rates of administration will depend on a number of factors such as the particular composition being administered, the age, body weight, general health, sex and dietary requirements of the subject, as well as any drugs or agents used in combination or coincidental with the compositions. For example, several divided doses may be administered hourly, daily, weekly, monthly or at other suitable time intervals or the dose may be proportionally reduced as indicated by the exigencies of the situation. Erased on the teaching herein those skilled in the art will, by routine trial and experimentation, be capable of determining suitable dosage regimes on a case-by-case basis.

[0073] Compositions and methods of the present disclosure may be employed as an adjunct to other therapies or treatments for gastrointestinal disorders and/or for improvement of the immune function and conditions associated therewith. Accordingly compositions and methods disclosed herein may be coadministered with other agents that may facilitate a desired therapeutic outcome, for example, one more renal drugs. By “coadministered” is meant simultaneous administration in the same formulation or in two different formulations via the same or different routes or sequential administration by the same or different routes. By “sequential” administration is meant a time difference of from seconds, minutes, hours or days between the administration of the agents, compositions or treatments. Sequential administration may be in any order.

[0074] The reference in this specification to any prior publication (or information derived from it), or to any matter which is known, is not, and should not be taken as an acknowledgment or admission or any form of suggestion that that prior publication (or information derived from it) or known matter forms part, of the common general knowledge in the field of endeavour to which this specification relates.

[0075] The present disclosure will now7 he described with reference to the following specific examples, which should not be construed as in any way limiting the scope of the invention.

Examples [0076] The following examples are illustrative of the invention and should not be construed as limiting in any w7ay the general nature of the disclosure of the description throughout this specification.

Example 1 - Oral powder compositions

Example 1A

[0077] An exemplary powder composition for oral administration is prepared by combining the following components:

Saccharomyces cerevisiae (spp. boulardii) 5 billion cfu / 5 g composition L-Glutamine 2 g / 5 g composition

Arabinogalactan (ResistAid™) 2 g / 5 g composition Peppermint Leaf extract 100 mg / 5 g composition (equivalent dry peppermint 500 mg)

Steviol glycosides 11.111 mg / 5 g composition

Silica - colloidal anhydrous 100 mg / 5 g composition

Cocoa Powder 465 mg / 5 g composition

Gluten free Dairy7 free [0078] In particular exemplary7 compositions the dosage is 5 g of the powder (typically 5 g dissolved in 250 mL water or other liquid) to be taken once or twice daily as required.

Example 1B

[0079] An exemplary powder composition for oral administration is prepared by combining the following components:

Saccharomyces cerevisiae (spp. boulardii) 5 billion cfu / 6 g composition L-Glutamine 2 g / 6 g composition

Arabinogalactan (ResistAid™) 2 g / 6 g composition Peppermint Leaf extract 100 mg / 6 g composition (equivalent dry peppermint 500 mg)

Gluten free Dairy' free [0080] In particular exemplary compositions the dosage is 6 g of the powder (typically 6 g dissolved in 250 mL water or other liquid) to be taken once or twice daily as required.

Example 1C

[0081] An exemplar}' powder composition for oral administration is prepared by combining the following components:

Stevio! glycosides 11.111 mg / 6 g composition

Silica - colloidal anhydrous 100 mg / 6 g composition

Cocoa Powder 465 mg / 6 g composition

Gluten free Dairy' free [0082] In particular exemplary compositions the dosage is 5 g of the powder (typically 5 g dissolved in 250 mL water or other liquid) to be taken once or twice daily as required.

Claims

Claims

1. A composition for promoting and supporting gastrointestinal health and/or immunological function, comprising a yeast strain of the genus Saccharomyces, glutamine and a source of fibre,
2. A composition according to claim 1, wherein the yeast strain is Saccharomyces cerevisiae spp. boalardii, the glutamine is L-glutamine and the source of fibre is an arabinogalactan,
3. A composition according to claim 1 or 2, wherein the composition further comprises: one or more polyphenolic flavonoids; a peppermint extract; one or more sweeteners; silica; and/or cocoa powder,
4. A composition according to any one of claims 1 to 4, wherein the composition is for improving and/or treating irritable bowel syndrome, diarrhoea, or constipation in a subject.
5. A method of promoting and supporting gastrointestinal health and/or immunological function in a subject, comprising administering to the subject a composition according to any one of claims 1 to 4.