Patent Description:
The invention also relates to the composition for use in treatment and/or prevention of a disease in a mammal, such as a human and for use in treatment and/or prevention of food and/or alcohol poisoning in a mammal. The invention also relates to the composition for use as a food supplement.

Food or alcohol poisoning deplete the mammal body of fluids, salts, vitamins and energy. During and after food or alcohol poisoning, the mammal body is in need for fluid, salt, mineral, vitamins and energy replacement. The illness caused by bacteria/virus/fungi must be removed from the mammal body, i.e. the body must recover after the illness. Most antibiotics affect normal fluid and salt balance in the body. Also, alcohol affects fluid and salt balance. Furthermore, food and alcohol poisoning negatively affect microbiotic flora in the intestines. This flora must be restored/repaired after removal of the bacteria/virus/fungi and alcohol, which repair is energy consuming for the body.

Products used during food and alcohol poisoning are fluid replacement products used to supply the body with fluids and salts. Some of the products may include vitamins, such as vitamin B and C. These same products may be used after a training session to prevent or overcome muscle aches.

The bacteria Pediococcus Pentosaceus (P. Pentosaceus) is a gram-positive, homo-fermentative, facultative anaerobic lactic acid bacteria. Pediococcus Pentosaceus is used in fermentation processes, e.g. for the production of Mediterranean traditional sausages. Pediococcus Pentosaceus has gained interest in both the food and medical field because of its positive effects as a probiotic. Pediococcus Pentosaceus has been tested against Samonella and Streptococcus and E. Coli, as well as for treatment of alcohol induced liver injuries, such as alcohol liver disease. Pediococcus Pentosaceus is general recognized as safe (GRAS) by the FDA.

Yeast, especially nutritional yeast, is rich in nutrients, salts and vitamins. Yeast may even be fortified with more vitamins. Yeast may be used as a probiotic.

Saccharomyces cerevisiae is the main source of nutritional yeast, which is sold commercially as a food product. It is popular with vegans and vegetarians as an ingredient in cheese substitutes, or as a general food additive as a source of vitamins and minerals, especially amino acids and B-complex vitamins.

Several clinical and experimental studies have shown that Saccharomyces cerevisiae var. boulardii is, to lesser or greater extent, useful for prevention or treatment of several gastrointestinal diseases. Saccharomyces cerevisiae var. boulardii seems to reduce risk for antibiotic-associated diarrhea both in adults and in children and to reduce risk of adverse effects of Helicobacter pylori eradication therapy. Also, some limited evidence supports efficacy of Saccharomyces cerevisiae var. boulardiiHansen CBS <NUM> in prevention (but not treatment) of Hansen CBS <NUM> diarrhea and, at least as an adjunct medication, in treatment of acute diarrhea in adults and children and of persistent diarrhea in children. It may also reduce symptoms of allergic rhinitis. Administration of S. cerevisiae var. boulardii is considered generally safe. In clinical trials, it was well tolerated by patients, and adverse effects rate was similar to that in control groups (i.e. groups with placebo or no treatment). No case of S. cerevisiae var. boulardii fungemia has been reported during clinical trials.

Defeating food and alcohol poisoning today is still a slow process, which may take several days or weeks. There are no products on the market to provide the body with all nutrients and minerals etc. needed to bring back the balance in the body after poisoning. There is a need for products that help recovery after poisoning and improve the time needed to recover. There is a need for reducing socioeconomical problems related to hangovers. There is a need for a product that increases the rate by which alcohol and its metabolic products can be removed from the human body.

<CIT> describes a product that can be used to counter the side effects of alcohol intake, "hangover". The product includes bacteria (not Pediococcus Pentosaceus) (<NUM>-12wt%), yeast (<NUM> wt%), sugar (<NUM>-<NUM> wt%), minerals and among others milk thistle, N-acetyl-L-cysteine and vitamins B and C. No results are shown of the effect of this complex and expensive product. The product tablet is large and has a weight of <NUM> to <NUM>. Such large tablets are difficult to administer.

<CIT> describes a product that counteracts the toxic effects of alcohol. The product contains a mixture of anaerobically fermented bacteria (Pediococcus Pentosaceus, Pediococcus acdilactici and Lactobacillus plantarum) in an amount of <NUM> wt% and sugar, vitamins and minerals and other ingredients. The results show an effect that is slightly better than the effect of a comparison product that does not include bacteria.

<CIT> describes a new Pediococcus Pentosaceus strain that can be used against food poisoning.

<NPL>, shows that Pediococcus Pentosaceus can be used in food poisoning and detoxification or as a food supplement.

<CIT> discloses a composition comprising Bifidobacterium, Lactobacillus, and NAO+ for use in a method of reducing blood alcohol content; further probiotics which are useful suggested amongst others are Pedicoccus and Sacharomyces S.

<CIT> discloses a composition comprising at least one probiotic microorganism strain comprising Pediococcus in an amount sufficient to ameliorate at least one symptom of irritable bowel syndrome, inflammatory bowel disease, or gastritis in a mammal. Pediococcus in an amount of <NUM> million to about <NUM> billion Colony Forming Units (CFU) of the Pediococcus is <NUM> x <NUM> - <NUM>,<NUM> x <NUM>. P pentosaceus and yeast are mentioned in a list of bacteria and yeast.

<CIT> discloses a Pediococcus strain and at least one second probiotic microbial organism for use in treating autism spectrum disorder; the second probiotic microbial organism is at least one of Lactobacillus, Bifidobacterium or Saccharomyces; wherein Pedicocccus comprsises at least Pediococcus pentosaceus, the second strain is selected from a long list of bacteria or alternatively yeast.

<CIT> discloses a composition for alcohol degradation comprising probiotics, such as Lactobacillus, Bifidobacterium, Streptococcus and Enterococcus. The composition may further comprise licorice extract, milk thistle and Pediococcus. In the compositions of the example a long list of bacteria is included in the composition.

<CIT> discloses a composition in unit dosage form for oral ingestion by a human in need thereof for relieving the symptoms associated with excessive alcohol consumption, comprising an effective amount of at least one magnesium salt, at least one calcium salt, ascorbic acid, at least one sugar alcohol, at least one botanical, at least one probiotic, at least one yeast culture i.e. Saccharomyces boulardii, and N-acetyl-L-cysteine.

<CIT> discloses a combiomic composition for preservation of animal food products. The composition comprises several microbial organisms, such as different types of bacteria or yeast.

<CIT> discloses a omposition comprising P. pentosaceus and yeast for use in animal food. No CFU amounts are disclosed for P. pentosaceus nor for yeast. Other bacteria, such as Bacillus subtilis and lactic acid bacteria as well as an enzyme are included in the composition. In Example <NUM> a feed, food for drinking comprising <NUM> parts by weight of yeast liquid and <NUM> parts by weight of Pediococcus pentosaceus, and <NUM> parts by weight of Bacillus subtilis; corresponding to a weight ratio of <NUM>-<NUM> : <NUM>.

Some products that reduce alcohol poisoning, for example as developed by Prof. Yungfeng Lu, University of California, contain enzymes. These products have been tested in mice. Even if successful in humans, such products are expensive to manufacture.

It is an object of the present invention to at least partly overcome the above-mentioned problems, and to provide an improved composition for use in food or alcohol poisoning or for improved recovery from food or alcohol poisoning.

This object is achieved by a composition as set out in the appended set of claims.

The unique combination of ingredients in the composition of the invention provides for an improved recovery from food or alcohol poisoning. The Pediococcus Pentosaceus works as a probiotic agent. It is believed to inhibit growth of pathogenic bacteria and may thus be used for detoxing the body of a mammal from toxic bacteria/fungi/viruses, as well as having an anti-inflammatory and antioxidant function. It is also believed to improve motility of the intestines. It is further believed to improve uptake of salts and minerals in the intestine.

Pediococcus Pentosaceus is believed to breakdown alcohols and aldehydes. Especially after alcohol poisoning, ethanol and its metabolic products, such as ethanal and aldehydes, must be removed to overcome the poisoning. Pediococcus Pentosaceus improves the breakdown/removal of alcohols and its metabolic products and thus improves the recovery of an alcohol poisoning.

The prior art suggests doses for probiotics that are billions times higher compared to the dose used in the composition of the invention. The minor effects disclosed in the prior art seem to be a result of a combination of specific probiotics at extreme high doses. The risk for side effects may increase when using such high doses. The intestine mobility for example is increased by P. pentosaceus. At high dose, the increase in mobility of the intestine may cause side effects. By using a much (billion times) lower dose, the side effects can be prevented.

There are neither any data available for a composition comprising only one probiotic, such as P. pentosaceus. The known literature seems to teach away from the use of P. pentosaceus as the sole bacterium/probiotic.

However, excellent results have been obtained using P. pentosaceus as a sole bacterium at a low dose of <NUM> or <NUM> wt% or less at <NUM><NUM> to <NUM><NUM> CFU/g, or even <NUM> wt% or less at <NUM><NUM> to <NUM><NUM> CFU/g. The fact that only one bacterium can be used and the fact that this bacterium can be used at a low dose, reduces possible side effects and costs for production and manufacturing of the composition. This is especially interesting at large scale production.

Yeast includes minerals, fatty acids and vitamins, all of which are needed to overcome or recover from food or alcohol poisoning. Yeast may be fortified with vitamins.

pentosaceus and yeast have been suggested for treatment of several diseases. pentosaceus (in combination with other probiotics/bacterium), yeast has also been tested at doses that are billion times higher compared to the doses present in the composition of the invention. High doses may lead to unwanted side effects. In contrast to the known literature, it was found that excellent results can be obtained when yeast is used at a low dose of <NUM> wt% or less at <NUM><NUM> to <NUM><NUM> CFU/g, or even <NUM> wt% or less at <NUM><NUM> to <NUM><NUM> CFU/g, in combination with low doses of P. pentosaceus as mentioned above. The fact that only one bacterium can be used and the fact that the bacterium and the yeast can be used at a low dose, reduces possible side effects and costs for production and manufacturing of the composition. This is especially interesting at large scale production.

The unique ratio allows use of both P. pentosaceus and yeast at low amounts in the composition of the invention. It is believed that there is a synergistical effect when using P. pentosaceus and the yeast at these ratios.

A synergistical effect seems to exist between P. pentosaceus and the one or more yeast for removal of harmful substances and bacteria from the body. Together, they seem to be useful for prevention and/or treatment of food poisoning or alcohol poisoning. Together they are believed to be useful for the prevention and/or treatment of diseases, such as gastrointestinal diseases, diarrhea, especially acute diarrhea. Together they are believed to be useful for restoring fluids, salts, vitamins and energy in the mammal body during and/or after a food or alcohol poisoning.

Zinc is used in food supplements, in oral rehydration therapy (ORT) and as an astringent (a chemical that shrinks or constricts body tissues). During and after food and/or alcohol poisoning, the body becomes dehydrated. The presence of zinc in the composition improves rehydration of the body and may thereby be useful in prevention and recovery/treatment of food and/or alcohol poisoning or another disease, such as gastrointestinal diseases, diarrhea, especially acute diarrhea. The amount of zinc salt or zinc sulfate is preferably kept below <NUM> or <NUM> wt% to prevent side effects that may be caused by zinc overdosing.

Zinc is also used in the brewing process for optimal yeast health and performance. Without wanting to be bound by any theories, the presence of zinc may improve the performance of the one or more yeast and possibly the probiotic P. pentosaceus. This may explain why both P. pentosaceus and yeast are effective at doses that are billion times lower than known effective doses of both yeast and P. pentosaceus.

A combination of zinc and probiotic is believed to be more effective in the treatment of Antibiotic-associated Diarrhea as opposed to when probiotic was given alone.

Zinc seems to promote the repair of the intestinal mucosa. When a combination of zinc and probiotic is used, there is believed to be an advanced decrease in plasma diamine oxidase (DAO) activity, which is released following damage to the epithelial cells of the intestinal mucosa.

Zinc also deals with the restoration of the mucosal barrier integrity and enterocyte brush-border enzyme activity. Moreover, zinc promotes the function of the immune system and enhances mucosal repair.

Magnesium is used in food supplements, for relief of heartburn and dyspepsia, as an antacid ( a substance that neutralizes stomach acidity) and is used to relieve heartburn, indigestion or an upset stomach), and as a short-term laxative. Magnesium may be used in the treatment of constipation and diarrhea. During and after food and/or alcohol poisoning, the stomach may be upset, i.e. the production of acid in the stomach may be increase due to a disease or poisoning. The presence of magnesium in the composition reduces the acidity of the stomach fluid and may thereby be useful in prevention and recovery/treatment of food and/or alcohol poisoning or another disease, such as gastrointestinal diseases, diarrhea, especially acute diarrhea. The amount of magnesium salt or magnesium oxide is preferably kept below <NUM> or <NUM> wt% to prevent side effects that may be caused by magnesium overdosing.

Without wanting to be bound by any theories, the presence of magnesium may improve the performance of the yeast and possibly the probiotic P. pentosaceus. A reduced acidity of the stomach fluid may improve the effectivity of P. pentosaceus and/or yeast. This may explain why both P. pentosaceus and yeast are effective at doses that are billion times lower than known effective doses of both yeast and P. pentosaceus.

As mentioned above, both zinc and magnesium or salts thereof, are used in food supplements and both may be useful in prevention and recovery/treatment of food and/or alcohol poisoning or another disease, such as gastrointestinal diseases, diarrhea, especially acute diarrhea. Both zinc and magnesium may have a synergistic effect on P. pentosaceus and yeast. Possibly, by lowering the acidity in the stomach fluid by magnesium and additionally rehydrating the body and stimulating the efficiency of the yeast (and possibly P. pentosaceus) by zinc, the overall efficiency and effectiveness of the composition in preventing and treating the mentioned diseases/poisonings of the human body is improved.

Calcium or calcium carbonate is used in food supplements. Calcium is also used as an antacid. Like magnesium, calcium lowers the acidity of the stomach fluid. Calcium is further used as a phosphate binder for the treatment of hyperphosphatemia and for maintenance of haemodialysis and prevention and treatment of osteoporosis. During and after food and/or alcohol poisoning, the stomach may be upset, i.e. the production of acid in the stomach may be increase due to a disease or poisoning. The presence of calcium in the composition reduces the acidity of the stomach fluid and may thereby be useful in prevention and recovery/treatment of food and/or alcohol poisoning or another disease, such as gastrointestinal diseases, diarrhea, especially acute diarrhea. Calcium has been shown to have a beneficial influence on the microbiota in the gut. This is a result of the formation of amorphous calcium phosphate, which binds bile acids and other cytotoxic substances in the gut. Due to the precipitation of cytotoxic substances, the environment of the gut becomes less aggressive and possibly also influences the adhesion of the microbiota. The amount of calcium salt or calcium carbonate is preferably kept below <NUM> or <NUM> wt% to prevent side effects that may be caused by calcium overdosing.

Without wanting to be bound by any theories, the presence of calcium may improve the performance of the yeast and possibly the probiotic P. pentosaceus. A reduced acidity of the stomach fluid may improve the effectivity of P. pentosaceus and/or yeast in the stomach. This may explain why both P. pentosaceus and yeast are effective at doses that are billion times lower than known effective doses of both yeast and P. pentosaceus.

As mentioned above, both zinc and calcium or salts thereof, are used in food supplements and both may be useful in prevention and recovery/treatment of food and/or alcohol poisoning or another disease, such as gastrointestinal diseases, diarrhea, especially acute diarrhea. Both zinc and calcium may have a synergistic effect on P. pentosaceus and yeast. Possibly, by lowering the acidity in the stomach fluid by calcium and additionally rehydrating the body and stimulating the efficiency of the yeast (and possibly P. pentosaceus) by zinc, the overall efficiency and effectiveness of the composition in preventing and treating the mentioned diseases/poisonings of the human body is improved.

As mentioned above, zinc, magnesium and calcium or salts thereof, are used in food supplements and may be useful in prevention and recovery/treatment of food and/or alcohol poisoning or another disease, such as gastrointestinal diseases, diarrhea, especially acute diarrhea. Zinc, magnesium and calcium may have a synergistic effect on P. pentosaceus and yeast. Possibly, by lowering the acidity in the stomach fluid by magnesium and calcium, and additionally rehydrating the body and stimulating the efficiency of the yeast (and possibly P. pentosaceus) by zinc, the overall efficiency and effectiveness of the composition in preventing and treating the mentioned diseases/poisonings of the human body is improved.

Sodium is an electrolyte that regulates the amount of water in your body. Sodium also plays a part in nerve impulses and muscle contractions. Sodium chloride is used to treat or prevent sodium loss caused by dehydration, excessive sweating, or other causes. During and after food and/or alcohol poisoning or due to a disease, the amounts of electrolytes in the body are decreased and often need to be replenished. The presence of sodium in the composition may therefore be useful in prevention and recovery/treatment of food and/or alcohol poisoning or another disease, such as gastrointestinal diseases, diarrhea, especially acute diarrhea. The presence of sodium in the composition may therefore be useful in prevention and recovery/treatment of muscle aches.

Sodium may have a synergistic effect on P. pentosaceus and yeast. Possibly, by rehydrating the body, the overall efficiency and effectiveness of the composition in preventing and treating the mentioned diseases/poisonings of the human body is improved.

As mentioned above, both zinc, sodium or salts thereof, are used in food supplements and both may be useful in prevention and recovery/treatment of food and/or alcohol poisoning or another disease, such as gastrointestinal diseases, diarrhea, especially acute diarrhea. Zinc, and sodium may have a synergistic effect on P. pentosaceus and yeast. Possibly, by rehydrating the body by zinc and sodium and additionally stimulating the efficiency of the yeast (and possibly P. pentosaceus) by zinc, the overall efficiency and effectiveness of the composition in preventing and treating the mentioned diseases/poisonings of the human body is improved.

As mentioned above, zinc, sodium, magnesium and calcium or salts thereof, are used in food supplements and may be useful in prevention and recovery/treatment of food and/or alcohol poisoning or another disease, such as gastrointestinal diseases, diarrhea, especially acute diarrhea. Zinc, sodium, magnesium and calcium, alone or in any combination, may have a synergistic effect on P. pentosaceus and yeast. Possibly, by lowering the acidity in the stomach fluid by magnesium and/or calcium, and additionally rehydrating the body by zinc and sodium and stimulating the efficiency of the yeast (and possibly P. pentosaceus) by zinc, the overall efficiency and effectiveness of the composition in preventing and treating the mentioned diseases/poisonings of the human body is improved.

Sugars are useful for restoring energy levels in the mammal body during and after food or alcohol poisoning.

Salts, minerals and sugar need to be replenished during and after food or alcohol poisoning or a training session. By combining these ingredients together with the probiotic Pediococcus Pentosaceusa and yeast, the composition of the invention can be used for treatment and/or prevention of food and alcohol poisoning or for treatment of muscle aches. Known compositions may include a probiotic or a mineral or minerals and vitamins. Some known composition may even include yeast and minerals. The composition of the invention comprises a unique combination of specific ingredients at specific ratios that allows for an improved recovery from food or alcohol poisoning, optionally together with antibiotics.

The invention will now be explained more closely by the description of different embodiments of the invention and with reference to the appended figures.

<FIG> shows a graph visualizing reduction of alcohol from the human body with and without administration of the composition of the invention at the start of the alcohol intake at time o hours.

As used herein "dextrins" means a group of low-molecular-weight carbohydrates produced by the hydrolysis of starch or glycogen. Dextrins are mixtures of polymers of D-glucose units linked by α- or α- glycosidic bonds.

As used herein "Pediococcus Pentosaceus" means any strain of the P Pentosaceus known to be useful as a probiotic.

As used herein "yeast" means any nutritional yeast, such as bakery/brewery yeast, such as Saccharomyces strains having probiotic activity. Yeast is not a bacteria.

As used herein "minerals" includes minerals, metals and salts oxides or sulfates or carbonates thereof.

As used herein the expression "one or more" means that there may be one of the feature or more than one.

As used herein "composition" may be one or two dosage forms (e.g. one or two tablet or one or two capsule), which together comprise or consist of the ingredients described in this description.

As used herein the expression "hangover" means alcohol poisoning.

The invention relates to a composition as set out in the appended set of claims.

The one or more yeast may be selected from the group comprising S. Cerevisiae strain Kyokai no. <NUM> (K7), S. Cerevisiae strain ATCC <NUM>, S. Cerevisiae strain S288c, S. Cerevisiae strain YGL118W, S. Cerevisiae strain YBR134C, S. Cerevisiae strain YDL102W, Saccharomyces cerevisiae var. boulardii and Saccharomyces cerevisiae var. boulardii Hansen CBS <NUM>, , or mixtures thereof. The one or more yeast may be Saccharomyces cerevisiae var. The one or more yeast may be Saccharomyces cerevisiae var. CNCM I-<NUM>. The one or more yeast may be Saccharomyces cerevisiae var. strain DBVPG6763.

Pediococcus Pentosaceus may be selected from the group comprising P. pentosaceus CRAG3, P. pentosaceus SP2, P. pentosaceus OA1 and P. pentosaceus S3N3, P. pentosaceus SWU73571, P. pentosaceus DSM <NUM>,<NUM>, P. pentosaceus Q6, P. pentosaceus <NUM>, P. pentosaceus SL001, P. pentosaceus PP8, P. pentosaceus B49, P. pentosaceus S22, P. pentosaceus ICVB491 , P. pentosaceus ICVB491 , P. pentosaceus LUHS183,. pentosaceus LJR1, P,. pentosaceus T1, P. pentosaceus LJR1 [, P. pentosaceus Z13P, P. pe,ntosaceus BaltBio02, , P. pentosaceus SK25, P. pentosaceus 4I1, P. pentosaceus MP12 , P. pentosaceus TG2, P. pentosaceus No. <NUM>, P. pentosaceus KCC-<NUM>, P. pentosaceus PPCS, P. pentosaceus HM, P. pentosaceus L006, P. pentosaceus K <NUM>-<NUM>, P. pentosaceus LMQS <NUM>, P. pentosaceus CFF4,, P. pentosaceus (TC48), P. pentosaceus ST65ACC, P. pentosaceus LJR1,, P. pentosaceus DT016, P. pentosaceus ATCC <NUM>,<NUM>, P. pentosaceus B49, P. pentosaceus GS4, P. pentosaceus AK-<NUM>, P. pentosaceus ON89A,. pentosaceus KFT18, P. pentosaceus NB-<NUM>, P. pentosaceus Sn26, P. pentosaceus M41, P. pentosaceus SL4, P. pentosaceus CRAG3, P. pentosaceus FP3, P. pentosaceus S-SU6, P. pentosaceus MYU <NUM>, P. pentosaceus AR243, P. pentosaceus DK1, P. pentosaceus LAB6, P. pentosaceus LP28, P. pentosaceus KID7, , P. pentosaceus FB145 , P. pentosaceus FB181, P. pentosaceus xy46, P. pentosaceus CFR R38 and R35, P. pentosaceus CFR R123, P. pentosaceus GY23, P. pentosaceus HN8, P. pentosaceus SB83, P. pentosaceus ATCC <NUM>,<NUM> and P. pentosaceus KID7, P. pentosaceus GS4, P. pentosaceus MZF16,, P. pentosaceus HLJG0702, P. pentosaceus LI05, P. pentosaceus CRAG3 and P. Pentosaceus HH-PP57, , or mixtures thereof. P ediococcus Pentosaceus may be P. pentosaceus strain HH-PP57.

The mineral may be zinc salt or zinc sulfate. The mineral may be magnesium salt or magnesium oxide. The mineral may be magnesium salt or magnesium oxide and zinc salt or zinc sulfate. The mineral may be calcium salt or calcium carbonate. The mineral may be calcium salt or calcium carbonate and zinc salt or zinc sulfate. The mineral may be calcium salt or calcium carbonate, magnesium salt or magnesium oxide and zinc salt or zinc sulfate. The mineral may be sodium salt or sodium chloride.

The mineral may be sodium salt or sodium chloride and zinc salt or zinc sulfate.

The yeast may be Saccharomyces cerevisiae var. boulardii, such as strain CNCM I-<NUM> or strain DBVPG6763. P ediococcus Pentosaceus may be P. pentosaceus strain HH-PP57.

The mineral may be sodium salt or sodium chloride, zinc salt or zinc sulfate, and magnesium salt or magnesium oxide and/or calcium salt or calcium carbonate.

Pharmaceutical acceptable excipients, additives and/or adjuvants refers to those compounds, materials, compositions, and/or dosage forms which are, within the scope of sound medical judgment, suitable for use in contact with the tissues of human beings and animals without excessive toxicity, irritation, allergic response, or other problem or complication, commensurate with a reasonable benefit/risk ratio and/or that are approved or approvable by a regulatory agency or body, for example the Food and Drug Administration or the European Medicines Agency.

Conventional procedures for the selection and preparation of suitable pharmaceutical formulations are described in, for example, "<NPL>.

For preparing the composition, inert, pharmaceutically acceptable carriers can be either solid or liquid. Solid form compositions include powders, tablets, dispersible granules, capsules, sachets, and suppositories. A solid carrier can be one or more substances, which may also act as diluents, flavoring agents, solubilizers, lubricants, suspending agents, binders, or tablet disintegrating agents; it can also be an encapsulating material.

Liquid form compositions include ointments, creams, gels, aqueous liquids, which may be suspesions or emultions (W/O or O/W).

If the composition is made into a tablet or capsule, the final tablet or capsule may have a weight of <NUM> to <NUM>, or from <NUM> to <NUM>, or from <NUM> to <NUM>, or from <NUM> to <NUM> or from <NUM> to <NUM>. The composition may be divided over two tablets or capsules or sachets and the like, each having a weight of <NUM> to <NUM>.

The composition may be a liquid, such as a suspension or an O/W emulsion.

One or more pharmaceutical acceptable excipients, additives and/or adjuvants may be selected from the group comprising or consisting of cellulose, such as microcrystalline cellulose, potato fiber, rice fiber, psyllium, (poly)saccharide, glycol, propylene glycol, polyethylene glycol <NUM>, monooleate, sorbitan monolaurate (Span <NUM>), anionic or nonionic surfactants, anti-foaming agents , wetting agent, such as monopalmitate, sucrose dioleate, detergent, such as sorbitan monolaurate, triethanolamine oleate, PEG-<NUM> laurate. solubilizer, such as monopalmitate (Tween <NUM>), sodium oleate, polyoxyethylene stearate, magnesium stearate, potassium oleate, preservatives, such as sorbic acid, viscosity modifiers/ suspending agents, such as cellulose derivatives (e.g., methylcellulose, microcrystalline cellulose, carboxymethylcellulose, ethylcellulose, hydroxyethylcellulose, hydroxypropyl cellulose and hydroxypropyl methylcellulose etc), clays (e.g., hectorite, bentonite, aluminium and/or magnesium silicate), natural gums (e.g., acacia, guar gum, tragacanth, xanthan gum, alginates, carrageenan and locust bean gum), synthetic polymers (e.g., carbomers, polyvinyl pyrrolidone, polyvinyl alcohol and poloxamer), and miscellaneous compounds (e.g., colloidal silicon dioxide and silicates).

The excipients/additives/adjuvants may be cellulose. The cellulose may be selected from the group comprising or consisting of microcrystalline cellulose (E460i) and powdered cellulose (E460ii), hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxyethyl methylcellulose, hydroxypropyl methylcellulose (HPMC), methylcellulose, ethylcellulose, ethyl methylcellulose, ethyl hydroxyethyl cellulose, carboxymethyl cellulose, or any combination thereof. The cellulose may be hydroxypropyl methylcellulose.

Other additives may be synthetic polymers, such as polyvinylpyrrolidone (PVP) and polyethylene glycol (PEG), gelatin, sucrose, lactose, sorbitol, xylitol and mannitol. Further additives may be anti-caking agents such as magnesium stearate.

Any sugar commonly used in pharmaceutical compositions or food additives may be used. The sugar may be selected from the group comprising or consisting of fructose, sucrose, dextrose, acesulfame K, alitame, aspartame, dextrose, fructose, galactose, inulin, isomalt, lactitol, maltitol, maltose, mannitol, neohesperidin dihydrochalcone, saccharin, sodium cyclamate, sorbitol, sucralose, sucrose, tagatose, thaumatin, trehalose, xylitol or dextrin. The sugar may be dextrin.

The one or more minerals may be selected from the group comprising or consisting of calcium, sodium, zinc, potassium, magnesium, potassium chloride, sodium chloride, calcium phosphate, calcium chloride, calcium carbonate, calcium citrate and/or calcium ascorbate. The one or more minerals may be selected from the group comprising or consisting of zinc, magnesium, potassium chloride and sodium chloride. The one or more minerals may be selected from the group comprising or consisting of zinc, potassium chloride and sodium chloride. The one or more minerals may be selected from the group comprising or consisting of zinc, calcium, magnesium, potassium chloride and sodium chloride, or oxides or sulfates or carbonates thereof. The one or more minerals may be selected from the group comprising or consisting of zinc sulfate, magnesium oxide, potassium chloride and sodium chloride. The minerals may be selected from the group comprising or consisting of zinc, magnesium, sodium and calcium, or oxides or sulfates or carbonates thereof. The minerals may be selected from the group comprising or consisting of zinc sulfate, magnesium oxide, sodium chloride and calcium carbonate.

The composition can be manufactured in different ways. The composition may be manufactured in a process for preparation of a capsule/tablet comprising or consisting of the following steps.

The composition may be administered topically or orally. The composition may be administered orally. The composition may be administered intramuscular. The composition may be administered intravenously.

The optimum dosage and frequency of administration will depend on the particular condition being treated and its severity; the species; the age, sex, size and weight, diet, and general physical condition of the particular mammal; other medication the mammal may be taking; the route of administration; the formulation; and various other factors known to physicians and others skilled in the art. Administration may be done in one dosage form or two dosage forms. The two dosage form, which together comprise or contain the composition of the invention may be administered simultaneously.

The composition of the invention may be administered at the start of the first alcohol intake. Alcohol is expected to be removed from the body at an increased rate compared to when alcohol is administered without administration of the composition. The composition may be administered at the start of the alcohol intake and/or during and/or after alcohol intake. When the composition is administered during or (direct) after alcohol intake, the alcohol and its metabolic products are expected to be removed from the body at an increased rate compared to when alcohol is administered without administration of the composition.

In a dosage regime, the composition is administered at least together with the first alcohol consumption and together with the last alcohol consumption.

In an alternative dosage regime, the composition is administered at least together with the first alcohol consumption, two to three hours after the first alcohol consumption and together with the last alcohol consumption.

The composition of the present invention may be used in conjoint therapy with other conventional therapies used to linger symptoms accompanying food or alcohol poisoning.

One or more other conventional therapies may be selected from the group comprising analgesics/painkillers, antibiotics, bismuth subsalicylate (Ex. Pepto-Bismol), loperamide (Ex. Imodium), ginger root tea, green tea, and the like.

The composition as set out in the appended set of claims may be used in treatment and/or prevention of a disease in a mammal, such as a human or in treatment and/or prevention of food and/or alcohol poisoning. The one or more yeast may be Saccharomyces cerevisiae var. boulardii, such as strain CNCM I-<NUM> or strain DBVPG6763. The Pediococcus Pentosaceus may be P. pentosaceus HH-PP57.

It is further believed that the composition as defined anywhere herein improves the recovery rate from obesity, Improves Irritable Bowel Syndrome, ameliorates progression of non-alcoholic fatty liver disease, alleviates ethanol-induced liver injury, inhibits bacterial and fungal growth, inhibits inflammatory effects, ameliorates cholesterol metabolism and some related diseases, promotes biotransformation and utilisation of nutrients, alleviates liver toxicity imposed by chronic heavy metal exposure (e.g. cadmium, lead).

It is yet further believed that the composition as defined anywhere herein reduces the length of acute diarrhoea duration in infant, children and adults with. It is yet further believed that the composition as defined anywhere herein improves mental health, life quality, fatigue, pain and/or inflammation markers for patients with MS, candidiasis, dyspledenia and small intestine bacterial overgrowth. The composition is believed to improve reestablishment of normal gut microbiota, reduce gut translocation of pathogen, proteolysis pathogenic toxins (C. difficile, E. Colli, Cholera, H. pulori), reduce mucositis, stimulate the immune system, reduce pro-inflammatory responses, promote mucosal anti-inflammatory signalling effects, reduce antibiotic associated diarrhoea, alleviate against traveller's diarrhoea.

The composition is believed to be useful in oral rehydration therapy and muscle aching. The composition is believed to counteract the side effects of antibiotics.

The composition as defined anywhere herein may be used for conjoint treatment. Such conjoint treatment may be achieved by way of the simultaneous, sequential or separate dosing of the individual compositions for the prevention and/or treatment defined herein.

A pharmaceutical composition may comprise (i) the composition as defined anywhere herein, and (ii) an additional pharmaceutical active ingredient, and optionally one or more pharmaceutically acceptable excipient, carrier or diluent.

A pharmaceutical composition may comprise (i) the composition as defined anywhere herein, and (ii) an additional pharmaceutical active ingredient, and (iii) one or more pharmaceutically acceptable excipient, carrier or diluent.

The additional pharmaceutical active ingredient may be an antibiotic, such as an antibiotic used for treatment of food poisoning. The additional pharmaceutical active ingredient may be a drug used for treatment of alcohol poisoning. The additional pharmaceutical active ingredient may be a drug used in treatment of overdosing of opiates and the like.

Examples of an additional pharmaceutical active ingredient may be bismuth subsalicylate (Pepto-Bismol) or loperamide (Imodium) acetaminophen (Tylenol) or ibuprofen (Advil).

Examples of an additional pharmaceutical active ingredient may be rifaximin (Xifaxan) link or rifamycin (Aemcolo), ciprofloxacin (Cipro), Levaquin, ondansetron (Zofran), azithromycin (Zithromax, Zmax) or amoxillin.

The composition as defined anywhere herein may be used as food supplement or together with other food supplements.

A tablet which also comprises magnesium and calcium.

Microcrystalline cellulose was used up to <NUM> wt%.

The composition (<NUM> tablet) of example <NUM> was tested on <NUM> healthy Caucasian volunteers, <NUM> male, <NUM> female.

As predicted in <FIG>, the results in example <NUM> clearly show an increase in removal of alcohol from the human body, or increased metabolism of ethanol in the human body. All subjects drank excessive amounts of alcohol over a period of <NUM> to <NUM> hours. <NUM> to <NUM> hours after stopping the alcohol intake, almost all volunteers showed a minimum alcohol level using the breathing test that would allow them to drive a car in some countries.

Because the composition increases removal of alcohol in the body it is believed to be useful in treatment of alcohol poisoning.

Two capsules were made comprising together the following ingredients.

Magnesium stearate was used in amounts of less than <NUM> wt% or <NUM> wt%. Microcrystalline cellulose was used up to <NUM> wt%.

The composition of example <NUM> was divided over two capsules and used in example <NUM>.

A control, not using the composition of the invention is estimated to have an alcohol metabolism at an average rate of <NUM>/<NUM>/hour, which is the same as reducing aBAC level (grams of alcohol in <NUM> milliliters of blood) by <NUM> per hour. The expected promille for such a control person at <NUM>:<NUM> pm would be about <NUM>%.

The results are expected to show that the composition of the invention increases the removal of alcohol from the human body.

Claim 1:
A composition comprising
<NUM> to <NUM> wt%, at <NUM><NUM> to <NUM><NUM> CFU/g Pediococcus Pentosaceus, wherein P. pentosaceus is the sole bacterium in the composition,
<NUM> to <NUM> wt% at <NUM><NUM> to <NUM><NUM> CFU/g one or more yeast, such as any brewer's yeast or Saccharomyces cerevisiae, wherein the weight ratio of Pediococcus Pentosaceus : yeast is between <NUM> to <NUM>:<NUM>,
<NUM> to <NUM> wt% one or more minerals, and
optionally <NUM> to <NUM> wt% sugar, and up to <NUM> wt% pharmaceutical acceptable excipients, additives and/or adjuvants.