AU2016100500A4 - Probiotic compositions for rehydration - Google Patents

Abstract

Abstract Provided herein are compositions comprising: one or more probiotic microbial strains selected from Saccharomyces cerevisiae, Lactobacilus piantarun, Lactobacillu gasseri and Bifidobaicleriun breve; one or more of potassium ions, sodium ions and/or citrate ions; zinc; and a sugar. Also provided are concentrates for use in preparing an oral rehydration solution, comprising: one or more probiotic microbial strains selected from Saccharonyces cerevisiae, Lactobacillus plantarum, Lactobacillus gasseri and Bifidobacterium breve; one or more of potassium ions, sodium ions and/or citrate ions; zinc; and a sugar, wherein the concentrate is mixed with an aqueous medium prior to use to produce a liquid composition for oral administration.

Description

Probiotic compositions for rehydration

Field of the Art [001] The present disclosure relates generally to compositions and methods to provide probiotic supplements useful for the therapeutic and/or prophylactic treatment, amelioration and/or regulation of disease states or pathological conditions. More specifically the present disclosure relates to compositions comprising at least one probiotic microorganism in combination with potassium, sodium and/or citrate ions, zinc and a sugar. The disclosure also relates to uses of such compositions for rehydration and fluid replenishment and for use in the treatment of conditions in which rehydration and fluid replenishment is required, such as diarrhoea and to a lesser extent to decrease the risk of constipation by preventing fluid loss and fluid restriction that may then progress to dehydration or hypohydration.

Background [002] Maintenance of a healthy level of hydration of the human body is essential for the proper functioning of organs and metabolic processes. Electrolyte disturbance and dehydration, the excessive loss of body fluids including water and electrolytes, can compromise a variety of bodily functions and can result from exercise or disease, the latter often associated with poor gastrointestinal health such as diarrhoea and vomiting as well as constipation. Disturbances in water and electrolytes can also occur during attempts to lose weight, in women that are pregnant or breast-feeding, during infections that are accompanied with high fever or when performing work in extreme heat conditions.

[003] To combat dehydration, oral rehydration therapy typically involves the administration of an oral rehydration solution containing glucose and sodium in water. This can provide rapid, effective hydration through sodium ion absorption in the intestines, activated by glucose. Thus, water can be absorbed more rapidly from an ORS containing both sodium and glucose than from water alone. Oral rehydration solutions can be used to treat a variety of conditions including diarrhoea and vomiting and constipation, as well as to maintain a healthy level of hydration.

[004] There is a need for the development of improved compositions and formulations for rehydration and fluid replenishment and to assist in the maintenance of adequate hydration and gastrointestinal health.

Summary of the Disclosure [005] Provided herein are probiotic compositions comprising microbial strains selected from Lactobacillus rhamnosus, Lactobacillus plantarum, Lactobacillus bulgaricus, Lactobacillus gasseri, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus fermentum, Lactobacillus salvarius, Lactococcus lactis, Streptococcus thermophilus, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium animat is subsp. lactis, Bifidobacterium animalis subsp. animalis, Bifidobacterium infanlis, Bifidobacterium longum, Bifidobacterium pseudocalenulatum, and Saccharomyces cerevisiae.

[006] In a first aspect the present disclosure provides a composition comprising: (i) one or more probiotic microbial strains selected from Saccharomyces cerevisiae, Lactobacillus plantarum, Lactobacillus gasseri and Bifidobacterium breve; (ii) one or more of potassium ions, sodium ions and/or citrate ions; (iii) zinc; and (iv) a sugar.

[007] The composition may comprise two, three or four of said microbial strains. In one embodiment, the composition comprises Saccharomyces cerevisiae, Lactobacillus plantarum, Lactobacillus gasseri and Bifidobacterium breve.

[008] The Saccharomyces cerevisiae may be Saccharomyces cerevisiae spp. boulardii.

[009] In an exemplary embodiment, the potassium ions are provided in the form of potassium citrate.

[0010] In an exemplary embodiment, the sodium ions are provided in the form of sodium chloride.

[0011] In an exemplary embodiment, the citrate ions are provided in the form of citric acid, for example anhydrous citric acid.

[0012] In a particular embodiment, the composition comprises potassium citrate, sodium chloride and citric acid.

[0013] In an exemplary embodiment, the zinc is provided in the form of zinc gluconate.

[0014] The sugar may comprise glucose. The glucose may be anhydrous glucose.

[0015] In one exemplary embodiment, the composition comprises Saccharomyces cerevisiae, Lactobacillus plantarum, Lactobacillus gasseri, Bifidobacterium breve, potassium citrate, sodium chloride and citric acid, zinc gluconate and glucose.

[0016] In a second aspect the present disclosure provides a composition consisting essentially of: (i) one or more probiotic microbial strains selected from Saccharomyces cerevisiae, Lactobacillus plantarum, Lactobacillus gasseri and Bifidobacterium breve; (ii) one or more of potassium ions, sodium ions and/or citrate ions; (iii) zinc; and (iv) a sugar.

[0017] In an embodiment, the composition consists essentially of Saccharomyces cerevisiae, Lactobacillus plantarum, Lactobacillus gasseri, Bifidobacterium breve, potassium citrate, sodium chloride and citric acid, zinc gluconate and glucose.

[0018] The composition of the first or second aspect may be a rehydration composition for oral administration. In particular embodiments, the composition is mixed with an aqueous medium prior to oral administration. Typically the aqueous medium is water.

[0019] In a third aspect, the present disclosure provides a concentrate for use in preparing an oral rehydration solution or suspension, wherein the concentrate comprises: (i) one or more probiotic microbial strains selected from Saccharomyces cerevisiae, Lactobacillus plantarum, Lactobacillus gasseri and Bifidobacterium breve; (ii) one or more of potassium ions, sodium ions and/or citrate ions; (iii) zinc, and (iv) a sugar, wherein the concentrate is mixed with an aqueous medium prior to use to produce a liquid composition for oral administration.

[0020] The concentrate may comprise or consist, essentially of a composition of the first or second aspect.

[0021] 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.

[0022] In a fourth aspect, the present disclosure provides a method for rehydrating a subject, the method comprising administering to the subject a composition of the first aspect or second aspect or an oral rehydration solution or an oral rehydration solution prepared from a concentrate according to the third aspect.

[0023] The subject may be suffering from dehydration due to, for example, excessive sweating, vigorous exercise or a condition associated with dehydration. By way of example, the condition may be cramps, fever, diarrhoea, constipation, vomiting, or other gastrointestinal condition, such as irritable or inflammatory bowel syndrome, coeliac disease or lactose intolerance.

[0024] In a fifth aspect, the present disclosure provides a method for treating one or more symptoms of dehydration in a subject, the method comprising administering to the subject a composition of the first aspect or second aspect or an oral rehydration solution or an oral rehydration solution prepared from a concentrate according to the third aspect.

[0025] In a sixth aspect, the present disclosure provides a method for treating a condition associated with dehydration, or for assisting a subject to recover from a condition associated with dehydration, the method comprising administering to the subject a composition of the first aspect or second aspect or an oral rehydration solution or an oral rehydration solution prepared from a concentrate according to the third aspect.

[0026] In exemplary embodiments, the condition is cramps, fever, diarrhoea, vomiting, constipation or other gastrointestinal condition, such as irritable or inflammatory bowel syndrome, coeliac disease or lactose intolerance.

[0027] Also provided is the use of: one or more probiotic microbial strains selected from

Saccharomyces cerevisiae, Lactobacillus plantarum, Lactobacillus gasseri and

Bifidobacterium breve/, one or more of potassium ions, sodium ions and/or citrate ions, zinc; and a sugar, in the manufacture of a composition for rehydrating a subject, for treating one or more symptoms of dehydration and/or for treating a condition associated with dehydration, or for assisting a subject to recover from a condition associated with dehydration.

Detaited Description [0028] 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.

[0029] The articles “a” and “an” are used herein to refer to one or to more than one (/'.<?., 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.

[0030] 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.

[0031] 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.

[0032] In the context of this specification, the term “probiotic” is to be given its broadest construction and is understood to refer to a microbial cell population or preparation, or component of a microbial cell population or preparation, which when administered to a subject in an effective amount promotes a health benefit in the subject, [0033] In the context of this specification, the term “prebiotic” is to be given its broadest construction and is understood to refer to any non-digestible substance that stimulates the growth and/or activity of bacteria in the digestive system.

[0034] 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.

[0035] In the context of this specification, the term "associated with" means a condition, illness or disorder that is caused by, results from or is otherwise characteristic of or associated with dehydration.

[0036] 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.

[0037] 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.

[0038] 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.

[0039] 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.

[0040] Provided herein are compositions which find use in improving or assisting maintenance of hydration, an appropriate electrolyte balance, and gastrointestinal health. The compositions of the present disclosure comprise: (i) one or more probiotic microbial strains selected from Saccharomyces cerevisiae, Lactobacillus plantarum, Lactobacillus gasseri and Bifidobacterium breve; (ii) one or more of potassium ions, sodium ions and/or citrate ions, (iii) zinc; and (iv) a sugar.

[0041] The composition may comprise any two or more or three or more of said strains. In an exemplary embodiment, the composition comprises all of said strains.

[0042] The amounts of individual microbial strains included in compositions disclosed herein may depend on a variety of factors including the identity and number of individual strains employed and the form in which the composition is to be administered. By way of example only, the amount of each microbial strain present in a single 5 gram dose of a composition disclosed herein may be from about 1 x 102 cfu to about 1 x 1011 cfu, and may be about 1 x 103 cfu, about 2.5 x 103 cfu, about 5 x 103 cfu, about 7.5 x 103 cfu, 1 x 104 cfu, about 2.5 x 104 cfu, about 5 x 104 cfu, about 7.5x 10'* cfu, about 1 x 105 cfu, about 2.5 x 105 cfu, about 5 x 10’ cfu, about 7.5 x 105 cfu, about 1 x 106 cfu, about 2.5 x 106 cfu, about 5 x 106 cfu, about 7.5 x 10° cfu, about 1 x 10' cfu, about 2.5 x 10 ' cfu, about 5 x 10' cfu, about 7.5 x 10 ' cfu, about 1 x 10s cfu, about 2.5 x 10s cfu, about 5 x 10s cfu, about 7.5 x 10s cfu, about 1 x 109 cfu, about 2.5 x 109 cfu, about 5 x 109 cfu, about 7.5 x 109 cfu, about 1 x 1010 cfu, about 2.5 x 10f 0 cfu, about 5 x 101(j cfu, about 7.5x 1()10 cfu, and about 1 x 1011 cfu.

[0043] In exemplary embodiments, each strain is present in an amount of about 2 x 109 cfu per 5 gram dose of the composition. Thus, in one embodiment, the composition comprises about 2 billion cfu Saccharomyces cerevisiae spp. boidardii, about 2 billion cfu Lactobacillus plantarum, about 2 billion cfu Lactobacillus gasseri and about 2 billion cfu Bifidobacterium, breve per 5 gram dose.

[0044] The composition may further comprise one or more additional probiotic bacterial strains. Suitable additional 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 bulgaricus, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus fermentum, Lactobacillus sal van us, Lactococcus lactis, Streptococcus thermophilus, Bifidobacterium bifidum, Bifidobacterium animalis subsp. lactis (B. lactis), Bifidobacterium animalis subsp. animalis (B. animalis), Bifidobacterium infantis, Bifidobacterium longum and Bifidobacterium pseudocatenulatum, [0045] Also contemplated by the present disclosure are variants of the microbial strains described herein. As used herein, the term "variant” refers to both naturally occurring and specifically developed variants or mutants of the microbial strains disclosed and exemplified herein. 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 as probiotic strains. Illustrative examples of suitable methods for preparing variants of the microbial 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.

[0046] Also encompassed by the term “variant” as used herein are microbial 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.

[0047] The bacterial strains to be employed in accordance with the present disclosure may be cultured according to any suitable method known to the skilled addressee and may be prepared for addition to a composition by, for example, freeze-drying, spray-drying or lyophilisation. Thus, in embodiments of the present disclosure the bacterial strains may be in a dried form (such as lyophilized or sporulated form) in a suitable earner medium, for example a FOS medium or other soluble fibre, sugar, nutrient or base material for the composition, with which the bacterial strains can be presented in an orally administrable form. One or more of the strains may be encapsulated in, for example, a suitable polymeric matrix to improve long term stability and storage of the compositions. In one example, encapsulation may comprise alginate beads, although those skilled in the art will appreciate that any suitable encapsulation material or matrix may be used. Encapsulation may be achieved using methods and techniques known to those skilled in the art.

[0048] The potassium ions may be provided in any suitable form, for example as potassium citrate, potassium chloride, potassium phosphate, potassium sulphate, or any combination thereof. In a particular embodiment, the potassium ions are provided in the form of potassium citrate.

[0049] The composition may provide potassium ions at a concentration of between about 5 mmol per litre and about 30 mmol per litre of the composition when the composition is in a ready to drink form constituted with an aqueous medium, typically water. The composition may provide potassium ions at a concentration of between about 7 mmol and about 30 mmol, or between about 9 mmol and about 30 mmol, or between about 11 mmol and about 30 mmol, or between about 13 mmol and about 30 mmol, or between about 15 mmol and about 30 mmol, or between about 17 mmol and about 30 mmol, or between about 19 mmol and about 30 mmol, or between about 21 mmol and about 30 mmol, or between about 23 mmol and about 30 mmol, or betv/een about 25 mmol and about 30 mmol per litre. In an exemplary embodiment, the composition provides potassium ions at a concentration of about 22 mmol per litre.

[0050] The composition may comprise potassium citrate at an amount of between about 100 mg and about 1000 mg per 5 gram dose of the composition. For example, the amount of potassium citrate present in a single 5 gram dose of a composition disclosed herein may be about 100 mg, about 200 mg, about 300 mg, about 400 mg, about 500 mg, about 600 mg, about 700 mg, about 800 mg, about 900 mg or about 1000 mg per 5 gram dose. The composition may comprise potassium citrate at an amount of between about 400 mg and about 500 mg per 5 gram dose, for example about 400 mg, 410 mg, 420 mg, 430 mg, 440 mg, 450 mg, 460 mg, 470 mg, 480 mg, 490 mg or 500 mg. In an exemplary embodiment the composition comprises about 449 mg potassium citrate per 5 gram dose.

[0051] The sodium ions may be provided in any suitable form, for example as sodium chloride, sodium citrate, sodium phosphate, sodium sulphate, or any combination thereof. In a particular embodiment, the sodium ions are provided in the form of sodium chloride.

[0052] The composition may provide sodium ions at a concentration of between about 20 mmol per litre and about 60 mmol per litre of the composition when the composition is in a ready to drink form constituted with an aqueous medium, typically water. The composition may provide sodium ions at a concentration of between about 20 mmol and about 60 mmol, between about 25 mmol and about 50 mmol, between about 30 mmol and about 50 mmol, between about 35 mmol and about 50 mmol, between about 40 mmol and about 50 mmol, or between about 45 mmol and about 50 mmol per litre. In an exemplary embodiment, the composition provides sodium ions at a concentration of about 46 mmol per litre.

[0053] The composition may comprise sodium chloride at an amount of between about 100 mg and about 1000 mg per 5 gram dose of the composition. For example, the amount of sodium chloride present in a single 5 gram dose of a composition disclosed herein may be about 100 mg, about 200 mg, about 300 mg, about 400 mg, about 500 mg, about 600 mg, about 700 mg, about 800 mg, about 900 mg or about 1000 mg per 5 gram dose. The composition may comprise sodium chlori de at an amount of between about 500 mg and about 600 mg per 5 gram dose, for example about 500 mg, 510 mg, 520 mg, 530 mg, 540 mg, 550 mg, 560 mg, 570 mg, 580 mg, 590 mg or 600 mg. In an exemplary embodiment the composition comprises about 533 mg sodium chloride per 5 gram dose.

[0054] The citrate ions may be provided in any suitable form, for example as citric acid, sodium citrate, potassium citrate, magnesium citrate, or any combination thereof. In a particular embodiment, the citrate ions are provided in the form of anhydrous citric acid.

[0055] The composition may comprise citric acid at an amount of between about 500 mg and about 1500 mg per 5 gram dose of the compositi on. For example, the amount of citric acid present in a single 5 gram dose of a composition disclosed herein may be about 500 mg, about 600 mg, about 700 mg, about 800 mg, about 900 mg, about 1000 mg, about 1100 mg, about 1200 mg, about 1300 mg, about 1400 mg or about 1500 mg per 5 gram dose. The composition may comprise citric acid at an amount of between about 800 mg and about 900 mg per 5 gram dose, for example about 800 mg, 810 mg, 820 mg, 830 mg, 840 mg, 850 mg, 860 mg, 870 mg, 880 mg, 890 mg or 900 mg. In an exemplary embodiment the composition comprises about 890 mg citric acid per 5 gram dose.

[0056] The zinc may be present as a zinc salt, such as zinc gluconate. The composition may provide the zinc in a form that provides an amount of zinc equivalent to about 1 mg to about 10 mg per 5 gram dose of the composition. The equivalent zinc amount may be about I mg, about 2 mg, about 2.5 mg, about 3 mg, about 3.5 mg, about 4 mg, about 4.5 mg, about 5 mg, about 5.5 mg, about 6 mg, about 6.5 mg, about 7 mg, about 7.5 mg, about 8 mg, about 8.5 mg, about 9 mg, about 9.5 mg, or about 10 mg per 5 gram dose. In an exemplary embodiment the composition comprises an equivalent zinc amount of about 6.4 mg per 5 gram dose.

[0057] The composition may provide zinc at a concentration of between about 0.1 mmol per litre and about 2 mmol per litre of the composition when the composition is in a ready to drink form constituted with an aqueous medium, typically water. The composition may provide zinc at a concentration of about 0.1 mmol, 0.2 mmol, 0.3 mmol, 0.4 mmol, 0.5 mmol, 0.6 mmol, 0.7 mmol, 0.8 mmol, 0.9 mmol, 1.0 mmol, 1.1 mmol, 1.2 mmol, 1.3 mmol, 1.4 mmol, 1.5 mmol, 1.6 mmol, 1,7 mmol, 1,8 mmol, 1,9 mmol or 2.0 mmol per litre. In an exemplar}^ embodiment, the composition provides zinc at a concentration of about 0.5 mmol per litre.

[0058] The composition may comprise zinc gluconate at an amount of between about 10 mg and about 100 mg per 5 gram dose of the composition. For example, the amount of zinc gluconate present in a single 5 gram dose of a composition disclosed herein may be about 10 mg, about 20 mg, about 30 mg, about 40 mg, about 50 mg, about 60 mg, about 70 mg, about 80 mg, about 90 mg, or about 100 mg per 5 gram dose. The composition may comprise zinc gluconate at an amount of between about 40 mg and about 50 mg per 5 gram dose, for example about 40 mg, 41 mg, 42 mg, 43 mg, 44 mg, 45 mg, 46 mg, 47 mg, 48 mg, 49 mg or 50 mg. In an exemplary embodiment the composition comprises about 44.8 mg zinc gluconate per 5 gram dose, [0059] The sugar may be present as a complex or simple sugar. In an exemplary embodiment the sugar is glucose. The glucose may be anhydrous glucose, [0060] The composition may provide glucose at a concentration of between about 50 mmol per litre and about 100 mmol per litre of the composition when the composition is in a ready to drink form constituted with an aqueous medium, typically water. The composition may provide glucose at a concentration of about 50 mmol, about 55 mmol, about 60 mmol, about 65 mmol, about 70 mmol, about 75 mmol, about 80 mmol, about 85 mmol, about 90 mmol, about 95 mmol or about 100 mmol per litre. In an exemplary embodiment, the composition provides glucose at a concentration of about 71 mmol per litre.

[0061] The composition may comprise glucose at an amount of between about 1 g and about 3 g per 5 gram dose of the composition. For example, the amount of glucose present in a single 5 gram dose of a composition disclosed herein may be about 1 g, about 1.5 g, about 2 g, about 2.5 g, or about 3 g per 5 gram dose. The composition may comprise glucose at an amount of between about 2 g mg and about 3 g per 5 gram dose, for example about 2 g, 2,1 g, 2.2 g, 2.3 g, 2.4 g, 2,5 g, 2.6 g, 2.7 g, 2.8 g, 2.9 g or 3 g per 5 g dose. In an exemplary embodiment the composition comprises about 2,5 g glucose per 5 gram dose.

[0062] In some embodiments, compositions of the present disclosure may further comprise one or more 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, raw chickory root and raw artichoke. The vitamins and minerals may be selected from, but not limited to: vitamins A, Bi, B2, B;, B5, B6, B9, Bi2, C, D, E and calcium, chromium, copper, fluorine, iodine, iron, magnesium, manganese, molybdenum, phosphorus, and selenium.

[0063] Compositions of the present disclosure may further comprise one or more amino acids. The amino 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.

[0064] Compositions of the present disclosure may further comprise one or more antioxidants or sources of antioxidant activity. Exemplar}' 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.

[0065] Compositions of the present disclosure may further 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 exemplar}'· 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.

[0066] 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.

[0067] In particular embodiments, the composition may be gluten free and dairy free, and suitable for ingestion by vegetarians.

[0068] Compositions of the invention can be readily manufactured by those skilled in the art using known techniques and processes. For example, the microbial strains can be seeded from standard stock into a reactor and 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.

[0069] 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.

[0070] 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.

[0071] By way of example, a 5 gram dose of a composition of the present disclosure may be added to 200 ml water and stirred immediately prior to administration to a subject.

[0072] Also provided herein are methods for rehydrating a subject, and for treating one or more symptoms of dehydration, comprising administering to a subject in need thereof a composition of the present disclosure. The subject may be suffering from dehydration due to, for example, excessive sweating, vigorous exercise or a condition associated with dehydration. Typical symptoms associated with dehydration include, but are not limited to: headache, decreased blood pressure, thirst, faintness, dizziness, fatigue, appetite loss, constipation, darkened urine, and dry mouth.

[0073] Also provided are methods for treating conditions associated with dehydration, or for assisting in the recovery from conditions associated with dehydration, comprising administering to a subject in need thereof a composition of the present disclosure. A number of conditions such as fever, cramps, diarrhoea, vomiting, constipation and other gastrointestinal conditions (such as irritable or inflammatory bowel syndrome, coeiiac disease or lactose intolerance) may lead to mild to severe dehydration, or be otherwise associated with dehydration. Thus, compositions of the present disclosure may be consumed by individuals suffering from such conditions in order to re-establish electrolyte balance and replace lost fluid, [0074] Compositions of the present disclosure may also be consumed before, during and/or after exercise, or other form of physical exertion, which may lead to a depletion in the amount of fluid and electrolytes in the body.

[0075] 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 gram dose of a composition of the present disclosure may be added to 200 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.

[0076] By way of example only, a suitable dose of a beverage prepared by the addition of 5 grams of composition to 200 mi of water may be 200 ml every' 30 mins (as required) for adults and for children over 12 years of age, 100 ml every' 30 mins (as required) for children between 6 to 12 years of age, 100 ml every 60 mins (as required) for children between 3 to 6 years of age, or 100 ml every 90 mins (as required) for children under 3 years of age. 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. Suitable dosages, frequency of administration of doses and length of time that administration is continued may be determined in consultation with a healthcare practitioner.

[0077] The reference in this specification to any prior publication (or information derived from it), or to any matter winch 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.

[0078] The present disclosure will now be described with reference to the following specific examples, which should not be construed as in any way limiting the scope of the invention.

Examples [0079] The following examples are illustrative of the invention and should not be construed as limiting in any way the general nature of the disclosure of the description throughout this specification.

Example 1 - Oral powder composition [0080] An exemplary probiotic composition according to the present disclosure has the following ingredients, per 5 gram dose:

Probiotic components:

Lactobacillus plantarum 2 billion cfu

Lactobacillus gasseri 2 billion cfu

Bifidobacterium breve 2 billion cfu

Saccharomyces cere visiae spp. boulardii 2 billion cfu

Other active components: S odium ch l ori de 533.2 mg

Equiv. sodium 209.7 mg (46 mmol/L in 200 ml water)

Equiv. chloride 323.5 mg (46 mmol/L in 200 mi water)

Potassium citrate 449.1 mg

Equiv. potassium 162.6 mg (22 mmol/L in 200 mi water)

Equiv. citrate 261.8 mg (30 mmol/L in 200 ml water)

Citric acid (anhydrous) 890.5 mg

Glucose (anhydrous) 2.5 g (71 mmol/L in 200 ml water)

Zinc gluconate 44.8 mg (1 mmol/L in 200 ml w7ater)

Equiv. zinc 6.4 mg (0.5 mmol/L in 200 ml water)

Other ingredients:

Natural orange flavour Silica

Steviol glycosides Natural colour

Gluten free Dairy free

Product may be formulated as a powder (typically 5 g dissolved in 200 mL water or other liquid) to be taken evety 30 min, 60 min or 90 min, as required.

Claims (5)

1. Claims

   1. A composition comprising: (i) one or more probiotic microbial strains selected from Saccharomyces cerevisiae, Lactobacillus plantarum, Lactobacillus gasseri and Bifidobacterium breve; (ii) one or more of potassium ions, sodium ions and/or citrate ions; (iii) zinc; and (iv) a sugar.
2. 2. A composition according to claim 1 or 2, wherein the composition comprises Saccharomyces cerevisiae, Lactobacillus plantarum, Lactobacillus gasseri and Bifidobacterium breve. a
3. 3. A composition comprising Saccharomyces cerevisiae, Lactobacillus plantarum, Lactobacillus gasseri, Bifidobacterium breve, potassium citrate, sodium chloride and citric acid, zinc gluconate and glucose.
4. 4. A concentrate for use in preparing an oral rehydration solution, wherein the concentrate comprises: (i) one or more probiotic microbial strains selected from Saccharomyces cerevisiae, Lactobacillus plantarum, Lactobacillus gasseri and Bifidobacterium breve; (ii) one or more of potassium ions, sodium ions and/or citrate ions; (iii) zinc; and (iv) a sugar, wherein the concentrate is mixed with an aqueous medium prior to use to produce a liquid composition for oral administration.
5. 5. A method for rehydrating a subject, for treating condition associated with dehydration one or more symptoms of dehydration, the method comprising administering to the subject a composition according to any one of claims 1 to 3 or an oral rehydration solution prepared from a concentrate according to claim 4.