Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
  • A61K35/66—Microorganisms or materials therefrom
  • A61K35/74—Bacteria
  • A61K35/741—Probiotics
  • A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
  • A61K35/747—Lactobacilli, e.g. L. acidophilus or L. brevis
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
  • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
  • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
  • A23L33/135—Bacteria or derivatives thereof, e.g. probiotics
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
  • A23L7/00—Cereal-derived products; Malt products; Preparation or treatment thereof
  • A23L7/10—Cereal-derived products
  • A23L7/104—Fermentation of farinaceous cereal or cereal material; Addition of enzymes or microorganisms
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
  • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
  • A61K31/716—Glucans
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
  • A61K35/66—Microorganisms or materials therefrom
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
  • A61K36/02—Algae
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
  • A61K36/18—Magnoliophyta (angiosperms)
  • A61K36/88—Liliopsida (monocotyledons)
  • A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
  • A61K36/18—Magnoliophyta (angiosperms)
  • A61K36/88—Liliopsida (monocotyledons)
  • A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
  • A61K36/8998—Hordeum (barley)
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
  • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P3/00—Drugs for disorders of the metabolism
  • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
  • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
  • A61P31/04—Antibacterial agents
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P37/00—Drugs for immunological or allergic disorders

Definitions

• a fermented composition comprising a high content of one or more lactic acid bacterial strains and a method for making the composition and use thereof
• the present invention relates to a fermented composition comprising a high content of one or more lactic acid bacterial strains and use thereof.
• the present invention also relates to a method for preparing a fermented composition, which comprises a high content of one or more lactic acid bacterial strains.
• compositions for use as a medicament comprising a fermented composition having a high content of one or more lactic acid bacterial strains.
• Probiotics are live microorganisms which are believed to provide health benefits, when administered to a human or an animal.
• Prebiotics refer to chemicals that induce the growth or activity of microorganisms e.g., bacteria and fungi) contribute to the well-being of the host. For example, when an individual animal, including humans, eats prebiotics, the composition of microorganisms in the intestinal microflora of the gastrointestinal tract is altered.
• Beta glucans can be found in grain, in particular oat and barley, other sources can be edible fungus/mushrooms, in particular mushrooms of the family Agaricus.
• the by-products obtained from lactic acid fermentation of beta glucan containing components, herein under macro algae (sea-weed), are considered to have a protective effect against the development of some cancer forms, gastrointestinal cancers and some leukaemia and lymphomas.
• the by-products has also in pilot studies by the inventor demonstrated effect on human cronic inflammatory conditions in the intestine (inflammatory bowel disease) and joints (arthritis and artropaties).
• beta-glucans have played a pivotal role in regulating the intestinal mucosal immune response due to interleukin signalling such as the interleukins: IL-1, IL6, IL10IL-17, IL21 and IL 23 probably due to the involvement of the innate immune system such as upregulating the Toll-like receptor TLR-2, TLR-4 and TLR-6.
• interleukin signalling such as the interleukins: IL-1, IL6, IL10IL-17, IL21 and IL 23 probably due to the involvement of the innate immune system such as upregulating the Toll-like receptor TLR-2, TLR-4 and TLR-6.
• a fermented composition comprising a dried fermented material comprising a high content of one or more lactic acid bacterial strains and a high content of beta-glucans, polysaccharides, oligosaccharides, proteoglycans and/or glycoproteins, wherein the fermented material is selected from one or more materials of vegetable origin, of fungal origin which is combined with a dried or dried and fer- mented second material originating from one or more species of seaweed, micro algae and/or macro algae.
• the inventor of the present invention surprisingly found that a fermented composition comprising a combination of probiotics and prebiotics promote the well-being of the individual and also provides unexpected and improved nutritional and/or pharmacological effects in animals and humans.
• the fermented product is found to have a stabilising effect on the mucosal layer of the bowel/digestive tract of mammals, such as humans or animals.
• the stabilising effect on the mucosal layer in the bowel has a positive effect to the wellbeing of the individual and may reduce certain symptoms related to diseases or conditions, that reduce the wellbeing of the individual.
• the fermented product comprising a combination of prebiotics and probiotics according to the present invention is believed to reduce or alleviate symptoms related to certain inflammatory and/or non-inflammatory diseases as discussed further below.
• Prebiotics are for example polysaccharides and/or oligosaccharides such as dietary fibers, in particular soluble dietary fibers.
• examples of such prebiotics are beta- glucans, lamiarin and fucoidan.
• Other prebiotics are e.g. proteoglycans and/or glyco- proteins.
• ⁇ -Glucans or beta-glucans comprise a group of ⁇ -D-glucose polysaccharides naturally occurring in the cell walls of cereals, yeast, bacteria, and fungi, with significantly differing physicochemical properties dependent on source.
• ⁇ -glucans form a linear backbone with 1-3 ⁇ -glycosidic bonds.
• some ⁇ -glucans may form a backbone with 1-3 ⁇ -glycosidic bonds with at least some branches of 1-6 ⁇ -glycosidic bonds
• ⁇ -glucans vary with respect to molecular mass, solubility, viscosity, branching structure, and gelation properties.
• Laminarin also known as laminaran
• a polysaccharide of glucose is also a ⁇ -glucan with ⁇ (l-3)-glycosidic bonds in the backbone and branches of (l-6)-glycosidic bonds) found e.g. in brown algae.
• Fucoidan is a sulfated polysaccharide (MW: average 20,000) and designates a group of certain fucose-containing sulfated polysaccharides that have a backbone built of (1- 3)-linked ⁇ -1-fucopyranosyl or of alternating (1-3)- and (l-4)-linked ⁇ -1-fucopyranosyl residues, but also include sulfated galactofucans with backbones built of (1 ⁇ 6)- ⁇ - ⁇ - galacto- and/or (l ⁇ 2)-P-d-mannopyranosyl units with fucose or fuco-oligosaccharide branching, and/or glucuronic acid, xylose or glucose substitutions.
• Fucoidan is found mainly in various species of brown algae, such as Ascophyllum nodosum and/or Sac- charina latissimi, and brown seaweed such as mozuku, kombu, bladderwrack, wakame, and hijiki. Fucoidan is used as an ingredient in some dietary supplement products and is believed to have immuno-stimulating properties as is the case with ⁇ - glucans.
• Macroalgaes are also known to contain components with the known activity as in the table below:
• proteoglycans and/or glycoproteins are important prebiotics.
• glycoproteins are important prebiotics.
• AGPs arabinogalactan-proteins
• glycoproteins are defined as proteins with a sugar attached to them. Glycoproteins may adhere to cells and enable development of functional tissues in the intestine such as creating increased intestinal mucus production and may also have anticoagulant properties which is found in both brown and green algaes. It has been suggested by several groups that probably the active compound or com- pounds of the algal species are related to high molecular weight polysaccharide, or a complex form with carbohydrate and protein (proteoglycan).
• the fermented composition comprises in particular a combination of one or more of oat (avenum sativum), barley ((Hordeum vulgare L.)) and/or one or more species of fungi, which is combined with a dried or dried and fermented material originating from one or more species of seaweed, micro algae and/or macro algae.
• the oat is an important source of beta glucans and is thus a preferred ingredient of the fermented composition according to the present invention.
• Most oats contain 3-6% ⁇ -glucan by weight.
• Oats can be selectively bred based on favourable ⁇ - glucan levels and/or one or more specific varieties of oat may be selected according to their content of ⁇ -glucan.
• Oat ⁇ -glucans are linear and linked at the 1,3 and 1,4 carbon sites.
• oat bran comprises high levels of beta glucans, such as from 5.5% to 23.0%) and it is thus in particular preferred to include oat bran in the fermented composition according to the present invention.
• barley Hordeum vulgare L.
• Barley contains glu- ten, which may make it an unsuitable grain for consumption by some people with gluten-related disorders, such as celiac disease, non-celiac gluten sensitivity and/or wheat allergy sufferers. Nevertheless, some wheat allergy patients can tolerate barley.
• barley may be another important but less preferred source of beta glucans and other dietary fibers to include in the fermented composition.
• any variety of oat and/or barley can be used in the fermented composition according to the present invention and/or a combination of one or more varieties of oat may be selected, based on their content of beta glucans.
• germinated oat and/or germinated barley also called malted barley or malted oat, may be used to pro- prise the fermented composition according to the present invention.
• the oat and/or barley used are a non-GMO species, i.e. the species are not genetically modified.
• the use of glyphosate resistant genetically modified strains of oat or barley should be avoided, because such genetically modified oats /barley strains may contain glyphosate, which is believed to have a negative impact on the intestinal mucosa and/or microbiotica in the intestines, especially in respect of neurotransmitter, e.g. dopamine, synthetizing gut mictobiotica.
• neurotransmitter e.g. dopamine
• synthetizing gut mictobiotica e.g. dopamine, synthetizing gut mictobiotica.
• other important functions, such as synthesis of secondary bile salts may be reduced or halted if the food contains glyphosates.
• the one or more species of fungus are in particular fungus selected from edible mushrooms, more particularly edible species of Agaricus, Reishi, Ganoderma Applanatum, Shiitake and/or Maitake, in particular species of agaricus such as Agaricus blazei Mu- rill, A. Bisporus, A. Essettei, A. Bitorquis A. Subfloccosus, A. vaporarius and/or A. Cupressicola, because these species and varieties of fungus also contain high concentrations of beta glucans. Certain species of seaweed, micro algae and/or macro algae are also rich in prebiotics, in particular ⁇ -glucans.
• Laminaria family such as in particular the species Lami- naria dentata, Laminaria saccharina, Laminaria digitata, Laminaria hyperborean, Laminaria Fuculencu, Laminaria Alata and/or Laminaria cichorioides contain significant amounts of ⁇ -glucans, in particular laminarin as mentioned above.
• Other sources of P-l,3/l,6-D-glucans, e.g. laminarin or similar ⁇ -glucans, and/or fuciodan may be Durvillaea antarctica (Chamisso), Alaria fistulosa, A.
• the fermented composition according to the present invention comprises one or more probiotic bacterial strain(s).
• a number of different strain(s) of probiotic bacteria may be used according to the present invention.
• the probiotic bacteria are lactic acid-producing bacteria (lactic acid bacte- ria).
• Lactic acid bacteria are often linked with food fermentations because they produce lactic acid during the fermentation process, which results in acidification of the fermentation broth.
• the acidification inhibits the growth of other unwanted microorganisms, e.g. pathogenic microorganisms.
• several lactic acid bacteria strains produce proteinaceous bacteriocins, toxins produced by bacteria to inhibit the growth of similar or closely related bacterial strain(s).
• lactic acid bacteria provide an additional hurdle for growth of other unwanted microorganisms, e.g. microorganisms, which are pathogenic and/or cause spoilage.
• the lactic acid bacteria are frequently used in production of food. In addition they contribute to the healthy microflora of maintaining the mucosal surfaces in humans and/or animals.
• the production of lactic acid and other metabolic products by the lactic acid bacteria may contribute to the nutritional, organoleptic, textural, and/or pharmacological profile of the fermented composition.
• Fermentation of the material comprising one or more materials of vegetable origin, of fungal origin and/or material originating from one or more species of seaweed, micro algae and/or macro algae using lactic acid bacteria causes degradation of the material, including the cell walls and thus renders the ⁇ -glucans and other prebiotics more readily available for digestion and or more readily available for the gut microflora present in the dietary tract if humans and animals.
• the material is not digested completely during fermentation, i.e. the fermentation process is stopped before degradation of the material is complete.
• the one or more lactic acid bacterial strains are selected from the group consisting of the genus Lactobacillus, Enterococcus, Pediococcus or Lactococcus, or combinations thereof.
• the one or more of the lac- tic acid bacteria strains are selected from one or more species from the genus of, Leu- conostoc, Streptococcus, Aerococcus, Carnobacterium, Oenococcus, Teragenococcus, Vagococcus, Bifidobacterium, Leucosporia and/or Weisella; these genera belong to the order Lactobacillales.
• the lactic acid bacteria are selected from the group consisting of Lactobacillus plantarum; Lactobacillus rhamnosus, Pediococcus pentosaceus; Pendiococcus acidilactici; Enterococcus faecium, and/or combinations thereof.
• the one or more lactic acid bacteria stain(s) is selected from the group consisting of one or more of Lactobacillus plantarum LSI (NCIMB 30083), Lactobacillus rhamnosus (NCIMB 30121, Enterococcus faecium (NCIMB 30122), Pediococcus pentosaceus HTS (LMG P-22549) and/or Pendiococcus acidilactici (NCIMB 30086).
• the one or more lactic acid bacterial strains are present in a total amount of 10 5 -10 12 CFU per gram because this provides the desired effects, because the fermented composition contains a high content of viable lactic acid bacteria and thus provides an effective daily dose of probiotics for humans and other animals in a daily dose of the fermented composition according to the present invention, which has a volume, which appears acceptable by most individuals, in particular humans.
• a particularly preferred fermented composition comprises a high level of prebiotics by means of a combination of minimum 50% (by weight) of a fermented material, which includes one or more of species of oat and/or barley, in particular grains and/or bran of oat and/or barley, and more particularly oat bran, and/or species of edible species fungus/mushrooms, such as mentioned above, and up to 30 % (by weight) of a dried or dried and fermented second material originating from one or more species of seaweed, micro algae and/or macro algae.
• the seaweed and/or algae in the second material is in particular selected from one or more of brown algae, such as Ascophyllum nodosum and/or Saccharina latissimi, red algae, green algae, such as kelps, Laminaria saccharina, Laminaria digitata, and/or Laminaria hyperborean.
• brown algae such as Ascophyllum nodosum and/or Saccharina latissimi
• red algae green algae, such as kelps, Laminaria saccharina, Laminaria digitata, and/or Laminaria hyperborean.
• the fermented composition may comprise minor amounts of one or more material originating from one or more Brassica species.
• the Brassica species may preferably be selected from one or more of rape species; the Brassica spp. may preferably be selected from one or more of rape species.
• the rape species is a rapeseed product, such as rapeseeds as such, rapeseed flour, or rapeseed cake, preferably rapeseeds or rapeseed flour.
• the material originating from brassica species may be present in an amount of up to 15% by weight, such as 1-10% by weight or more preferred 5-10% by weight.
• the fermented composition is pulverized, preferably after being dried, to provide a material having a final average particle size of up to ⁇ - lmm, preferably up to 100-500 ⁇ or more particular up to 100-1, ⁇ .
• the maximum size of the powder/granules can be up to ⁇ , ⁇ depending on the size of the nozzle used for making the tablets/capsules or pellets.
• the fermented composition is provided in a unit dosage form, said unit dosage form is present in a powder or paste, and optionally incorporated into capsules, tablets, caplets, lozenges, bags, a suspension, or the fermented composition is provided in a topical composition, such as an emollient, a cream or a suspension.
• Suitable adjuvants for making the above mentioned formulations of the fermented composition are in particular commonly used pharmaceutically acceptable components, such as by the fermented composition is enclosed by capsules made from macroalgae extracts, gelatine, or vegetable cellulosic based capsules, or by forming tablets, caplets or lozenges by using a binder such as agarose, lactose, dibasic calcium phosphate, sucrose, perenniale or potato starch, microcrystalline cellulose, povidone, poly- vinylpyrrolidone, modified cellulose, e.g.
• a binder such as agarose, lactose, dibasic calcium phosphate, sucrose, grasse or potato starch, microcrystalline cellulose, povidone, poly- vinylpyrrolidone, modified cellulose, e.g.
• the present invention also relates to a method for preparing a fermented composition as discussed above. The method comprises the steps of:
• a material comprising a high content of beta-glucans, polysaccharides, oligosaccharides, proteoglycans and/or glycoproteins, such as a combination of - one or more species of vegetable origin, in particular species of oat and/or barley and/or one or more species of fungus, in particular fungus selected from edible mushrooms, ,
• step b) subjecting the material to fermentation by combining the material provided in step a) with the one or more lactic acid bacterial strain(s) provided in step b), and
• material may be fractionized by grinding, cutting, chopping, slicing, and/or fractioniz- ing providing a fractionized material prior to the fermentation step.
• the initial fractionation may provide the material in a reduced size to increase the surface of the material and thus speed up the fermentation step, because the material becomes more easily available to the lactic acid bacteria during fermentation.
• the antioxidative effect may cause the fermentation by the lactic acid bacteria strains(s) to stop, at least for a period. After a certain period of time, which may be after several days or even several weeks the fermentation process may then sometimes restart. This will result in prolonged production time, which results in unwanted increased production costs.
• the method preferably comprises providing a first fraction of a first fermented material of one or more of species of oat, one or more species of barley and/or species of edible fungus, in particular fungus selected from edible mushrooms, such as men- tioned above providing a second fraction of a dried or dried and fermented material of one or more species of seaweed, micro algae and/or macro algae and combining the first and second fractions to provide a fermented composition as discussed above.
• Fermentation may initiated by adding a starter culture comprising one or more lactic acid bacterial strain(s) as discussed above or alternatively by adding a fraction of a previously fermented batch containing lactic acid bacteria strain(s) as discussed above.
• a starter culture comprising one or more lactic acid bacterial strain(s) as discussed above or alternatively by adding a fraction of a previously fermented batch containing lactic acid bacteria strain(s) as discussed above.
• Some materials e.g. seaweed, naturally contain lactic acid bacteria strains on the surface of the material, and inoculation using a starter culture may thus be avoided when fermenting such material or a material containing a large fraction thereof.
• the fermentation step or steps are performed at a steady state temperature in the range 15-45°C, such as 20- 45°C, such as 25-45°C, such as 30-40°C or such as 40-45°C depending on the opti- mum temperature of the one or more lactic acid bacterial strains.
• a steady state temperature in the range 15-45°C, such as 20- 45°C, such as 25-45°C, such as 30-40°C or such as 40-45°C depending on the opti- mum temperature of the one or more lactic acid bacterial strains.
• an initial temperature increase is provided by heat produced by the fer- mentation itself and thus without the use of energy from external energy sources in the initial phase.
• the temperature may be controlled by conventional temperature regulation means, e.g. electrical heating, to be within the above- mentioned ranges. This saves energy and reduces the overall production costs. It is essential that the fermentation process does not fully digest the material of vegetable, fungus or seaweed and/or algae origin, because this will eliminate or at least significantly reduce the content of prebiotics in the fermented composition. Even though the fermentation should be continued as quickly as possible, a certain time of fermentation is required to provide the desired degradation of the material as provided initially, in order to "open" the material (e.g. by at least a partial degradation of the cell walls in the material).
• conventional temperature regulation means e.g. electrical heating
• the fermentation step may be continued for up to 10 days, such as up to 9 days or less, e.g. 8 days or less, such as 7 days or less, e.g. 6 days or less, such as 5 days or less, e.g. 4 days or less, such as 3 days or less, e.g. 48 hours or less, or e.g. 24 hours or less.
• the material may be further supplemented with rice, beans, peas, soy, brassica spp, such as one or more of rape species, e.g. a rapeseed product and/or vegetables, preferably starch containing vegetables such as potatoes, or a flour thereof, in an amount of up to 1-15% (by weight) of the composition, such as up to 5-10% (by weight) of the initial material which is subjected to lactic acid fermentation.
• rape species e.g. a rapeseed product and/or vegetables, preferably starch containing vegetables such as potatoes, or a flour thereof
• the moisture content of the plant material to be fermented may be another relevant parameter to control in order to control the fermentation process and the resulting fermented composition.
• the moisture content during the fermentation may be in the range of 20-60% (w/w), such as in the range of 25-55%) (w/w), e.g. preferably in the range of 35-45%) (w/w).
• the fermentation occurs in practice in solid state as a paste, and thus similar to a silage process.
• the fermented material is preferably subjected to drying to allow for easy packaging and to allow for incorporation into tablets etc. as discussed above.
• the drying step conserves viable lactic acid bacteria in the material and thus prolongs the viability thereof.
• the drying step is preferably a gentle drying without the addition of heat or low addition of heat in order not to cause a significant reduction in the content of viable lactic acid bacteria in the fermented composition.
• Suitable drying techniques are e.g. freeze drying; vacuum drying, flash drying, or air drying at temperatures below 45°C.
• the fermented and optionally dried composition is preferably pulverized by grinding, cutting, chopping, slicing, and/or fractionizing, in particular to a final average particle size as mentioned above.
• the shear forces on the material which occurs during pulverisation, e.g. grinding processes and the like as mentioned above, results in a temperature increase of the pulverized material.
• the temperature increase may result in killing or inactivation of the viable lactic acid bacteria present in the fermented composition, which reduces the overall quality; in particular if an uncontrolled temperature increase occurs in the fermented composition. Therefore, in order to minimize or even eliminate the reduction in the count of viable lactic acid bacteria in the fermented composition, the pulverization of the material, in particular of the dried material, is carried out at temperatures below 40°C, such as within the range of 15-35°C, or in particular 20-35°C.
• the temperature of the final product is reduced by reducing the initial temperature of the material prior to pulverizing by subjecting the material to cooling, freezing and/or by pulverizing the material while cooling the pulverizing equipment, and/or by mixing the material with an inert cryogenic material, such as solid carbon dioxide, liquid nitrogen, or by pulverisation under a gaseous atmosphere having a controlled temperature range, e.g. as mentioned above and/or similar combinations thereof.
• an inert cryogenic material such as solid carbon dioxide, liquid nitrogen, or by pulverisation under a gaseous atmosphere having a controlled temperature range, e.g. as mentioned above and/or similar combinations thereof.
• the material is preferably pasteurized or sterilized prior to being fermented.
• the temperature increase during the initial pasteurisation or sterilisation step also re- suits in a partial (thermal) hydrolysis of the material of plant, fungus and/or algae/seaweed origin, which may promote the fermentation process, e.g. by releasing some of the nutrients present in that material and render these readily available for the lactic acid bacteria, at least during the start-up period of the fermentation process.
• the fermented composition which comprises a high level of prebiotics and probiotics, which is obtainable by the process as described above may thus be a food or feed product, a food or feed supplement or from part of a food/feed product or a food supplement.
• the terms "food” refers to edible material, which is intended for human consumption.
• feed refers to edible material, which is intended for animal consumption.
• animal(s) preferably includes domesticated animals or animals which are bred on a commercial manner, e.g. for food supply.
• animal may include pigs, piglets, cattle, horses, dogs, cats and poultry such as chicken, turkey, hens, ducks, geese and/or fish, e.g. salmon or trout.
• the food/feed product When used as an ingredient, additive or supplement in food/feed products, the food/feed product preferably comprises in the range 1-50% by weight of the dry feed/food ingredient, such as in the range 5-30%, such as 10-30% or such as 5-20%.
• the inventors of the present invention surprisingly found that the composition according to the present invention has nutritional and/or pharmacological effects.
• the fermented composition may be used in a natural medicine product (or a herbal medicine product); in a medicinal product and/or as an adjuvant product which is used in combination with one or more other drugs.
• adjuvant refers to a composition, which enhances or promotes the effects of another drug. Alternatively, the adjuvant may suppress unwanted side effects of another drug or a combination of other drugs.
• the present invention also relates to a composition for use as a medicament comprising a fermented composition having a high content of one or more lactic acid bacterial strains, and one or more materials of vegetable origin, of fungal origin and/or the material originates from one or more of seaweed, micro algae and/or macro algae having a high content of beta-glucans, polysaccharides, oligosaccharides, proteoglycans and/or glycoproteins.
• said substance comprises a fermented composition as described above or as being obtainable by the method as described above.
• the composition according to the present invention may be used in the treatment of, or as adjuvant to a conventional medical treatment, or for alleviation, stabilisation or prophylaxis of clinical diseases in a mammal (such as a human or an animal), where the composition comprises a fermented composition according to the present invention.
• the present invention may relate to a composition for use in the treatment, adjuvant treatment, alleviation, stabilising or prophylaxis of constipation; fatigue, inflammation, diarrhoea; inflammatory bowel diseases or irritable bowel syndrome, such as pan cholitis, duodenitis, ileitis, jejunitis, cholitis, sigmoiditis, morbus Crohn's disease, and/or cholitis ulcerosa; overweight or obesity, including severe obesity, and/or avoiding regaining weight after a gastric bypass surgery procedure; diabetes, in particular type 2 diabetes; allergy (such as gluten allergy and/or lactose allergy/atopic dermatitis); rheumatism or arthritis; connective tissue disorders, such as psoreasisartritis, pso- reasisartropatis, spondylartropatias or spondylarthritis, psoriasis,morbus bechterew, sclerodermi
• said composition comprises a fermented composition as described above or as being obtainable by a method as described above.
• the composition is an adjuvant product for administration in combination with one or more other drugs.
• a composition may comprise one or more drugs and the adjuvant, where the adjuvant comprises a fermented composition as described above, or as being obtainable by a method as described above.
• the fermented product according to the present invention is believed to normalize and/or activate the intestinal micro flora (i.e, the intestinal bacterias, virae, fungi) in humans and/or animals.
• normalization refers to restoring the intestinal microenvironment from a dysbiotic stage, e.g.
• the human/animal, experienced imbalance (dysbiosis) in the intestinal micro flora e.g. in connection with a disease as mentioned above and/or in connection with suffering from side effects in connection with taking another drug.
• activating refers to an increased activity of the intestinal micro flora, which exceeds the activity expected by the amount of lactic acid bacteria administered.
• researchers have found that often the cause of a disease, a condition, or an injury in mammals, i.e. human or animal individuals, is usually a result of an instable, abnormal and/or an infected intestinal flora. This may prime the human or animal organism to react, e.g.
• a fermented composition (or a substance) according to the present invention may be highly suitable for counteracting such discomfort, disease, condition, or injury or side effect(s) of another drug or a combination of other drugs.
• a disease may be a result of an inflammatory condition, or a non-inflammatory condi- tion.
• Non-inflammatory conditions are sometimes causing diffuse symptoms and may therefore be difficult to identify and cure.
• An example is irritated bowel syndrome (IBS), which is a non-inflammatory disorder of the intestines.
• IBS irritated bowel syndrome
• the fermented composition (or the substance) is used for the treatment, alleviation, stabilization or prophylaxis of irritated bowel syndrome.
• Psoriasis is a multiple of long-lasting autoimmune diseases characterized by patches of abnormal skin (hyperkeratosis). These skin patches are typically red, itchy, and scaly. They may vary in severity from small and localized to complete body coverage.
• the main types of psoriasis are plaque psoriasis, guttate psoriasis, inverse psoriasis, pustular psoriasis, and erythrodermic psoriasis.
• sequelae as a consequence of psoriasis are also encompassed by the definition of treatment, alleviation, stabilisation or prophylaxis of psoriasis.
• Sequelae that are associated with psoriasis are an increased risk of psoriatic arthritis, lymphomas, cardiovascular diseases, Crohn's disease, and depression.
• the fermented composition (or the substance) for the treatment, alleviation, stabilisation or prophylaxis of psoriasis may preferably comprise a fermented composition having a high content of one or more lactic acid bacterial strains and a high content of beta-glucans, polysaccharides, oligo- saccharides, proteoglycans and/or glycoproteins originating from one or more fermented materials of one or more species of oat, species of barley and/or species of fungus, in particular fungus selected from edible mushrooms as discussed above, which is combined with a dried or dried and fermented material originating from one or more species of seaweed, micro algae and/or macro algae, or said substance com- prises a fermented composition as described above, or as being obtainable by a method as described above.
• Psoriasis Area and Severity Index (PASI) of a mammal suffering from psoriasis is reduced by 10% or more when the fermented composition or the substance according to the present invention is administered to a mammal, such as 20% or more, e.g. 30% or more, such as 40% or more, e.g. 50% or more, such as 60% or more, e.g. 70% or more, such as 80% or more, e.g. 90% or more, such as 95% or more, e.g. 100%.
• PASI Psoriasis Area and Severity Index
• the fermented composition according to the present invention is suitable for administration to pregnant women, e.g., to treat, reduce or eliminate overweight and/or obesity, and/or avoiding regaining weight after a gastric bypass surgery procedure, diabetes, such as diabetes type 2 and/or pre-eclampsia in pregnant women.
• administration of the fermented composition according to the present inven- tion to pregnant women may reduce or even eliminate the risk of getting diabetes and/or pre-eclampsia during pregnancy and/or in connection with giving birth.
• the C-reactive protein is a pentameric protein found in blood plasma of a mammal.
• the levels of C-reactive protein may rise in response to inflammation and is used as a marker of inflammation. Measuring and charting CRP values can prove useful in determining disease progress or the effectiveness of treatments.
• one way to determine the extent or the severity of spondylarthritis may be by measuring the level of C- reactive protein (CRP) in a mammal.
• CRP C- reactive protein
• a maximum level (statistically evaluated) of CRP is accepted by the skilled person, whereby a mammal is still considered normal and healthy.
• the health authorities has set a value of 8 (statistically evaluated) as the borderline for distinguishing between a healthy and a non-healthy person - based on the CRP value.
• the maximum level of CRP accepted for a normal/healthy mammal may be a CRP value below 8.
• a mammal having a CRP level below 8 are considered normal and healthy and mammals having a CRP value of 8 or above are considered abnormal/sick.
• the CRP level in a mammal is lowered to a CRP level below 8 after administering one or more daily doses of the fermented composition according to the present invention, in the mammal.
• the CRP Level in a mammal is lowered to a CRP level below 8 in 5 months or less, such as in 4 months or less, e.g. in 3 months or less, such as in 2 months or less, e.g. in 1 months or less, such as in 25 days or less, e.g. in 22 days or less, such as in 20 days or less, e.g. in 18 days or less, such as in 17 days or less, e.g. in 16 days or less, such as in 15 days or less, e.g. in 14 days or less, such as in 12 days or less, e.g. in 10 days or less.
• the CRP level in a mammal is low- ered to a CRP level which is at most 75% of the CRP level before administering the fermented composition according to the present invention, determined as an average value over a period of 10 days, such as at most 60%, e.g. at most 50%, such as at most 40%), e.g. at most 30%>, such as at most 20%, e.g. at most 10%>.
• Tests have revealed that the CRP level is lowered in a mammal to a level below 8 after administering a daily dose of the fermented composition in a period of minimum 14 days. After interrupting the administration of the fermented composition for 14 days the CRP level again rose to a level above 8. The CRP level then again dropped to a level of below 8 when resuming the administration of a daily dose of the fermented product according to the present invention.
• Allergy include a number of allergic diseases or conditions caused by hypersensitivity of the immune system to something in the environment. In some cases the allergic reaction causes little but highly annoying problems in a mammal and in other situa- tions the allergic reaction may be severe and immediate action is needed.
• the allergic diseases may include hay fever, food allergies, atopic dermatitis, allergic asthma, allergic arthritis, atopic eczema, and anaphylaxis. Symptoms may include red eyes, an itchy rash, runny nose, shortness or trouble of breath, increased heart beating, suffocation, or swelling.
• the fermented composition (or the substance) for the treatment, alleviation, stabilisation or prophylaxis of allergy may preferably comprise a fermented composition having a high content of one or more lactic acid bacterial strains and a high content of beta-glucans, polysaccharides, oligosaccha- rides, proteoglycans and/or glycoproteins the latter originating from one or more fermented materials of one or more species of oat, species of barley and/or species of fungus, in particular fungus selected from edible mushrooms, more particularly edible species of fungus/mushrooms, such as discussed above, which is combined with a dried or dried and fermented material originating from one or more species of seaweed, micro algae and/or macro algae, or said substance comprises a fermented composition as described above, or as being obtainable by a method as described above.
• the fermented composition (or the substance) is suitable for the treatment, alleviation, stabilisation or prophylaxis
• a mammal suffering from allergy such as gluten allergy and/or lactose allergy
• the mammal may be able to eat normally afterwards, i.e. without eliminating gluten and/or lactose from the diet.
• Constipation refers to bowel movements that are infrequent or where the content of the intestines is hard to pass, which may result in feces which is hard and/or failure to pass stools or gas. Constipation is a common cause of painful defecation.
• Severe constipation includes obstipation and fecal impaction, which can progress to bowel obstruction and become life-threatening. Constipation is common. In the general popula- tion rates of constipation varies from 2 to 30%. Old people living in care homes the rate of constipation is 50% to 75%. Furthermore, sequelae as a consequence of constipation are also encompassed by the definition of treatment, alleviation, stabilisation or prophylaxis of constipation. Sequelae that are associated with constipation are spinal cord lesions, Parkinsons, colon cancer, anal fissures, proctitis, pelvic floor dysfunc- tion, anismus, descending perineum syndrome, and Hirschsprung's disease.
• the fermented composition (or the substance) for the treatment, alleviation, stabilisation or prophylaxis of constipation may preferably comprise a fermented composition having a high content of one or more lactic acid bacterial strains and a high content of beta-glucans, polysaccharides, oligosaccharides, proteoglycans and/or glycoproteins originating from one or more fermented materials of one or more species of oat, species of barley and/or species of fungus, in particular fungus selected from edible mushrooms, such as discussed above, which is combined with a dried or dried and fermented material originating from one or more species of seaweed, micro algae and/or macro algae, or said substance comprises a fermented composition as described above, or as being obtainable by a method as described above.
• the fermented composition (or the substance) is administered to a mammal in combination with one or more drugs in order to avoid the constipating side effect many medications have.
• constipation in a mammal may be treated or alleviated within 15 hours from intake of the fermented composition according to the present invention, such as within 10 hours, e.g. within 8 hours, such as within 6 hours, e.g. within 4 hours, such as within 3 hours, e.g. within 2 hours, such as within 1 hour.
• Fatigue is a subjective feeling of tiredness which is distinct from weakness, and has a gradual onset. Patients suffering from inflammatory diseases often also suffer from fatigue. Unlike weakness, fatigue can be alleviated by periods of rest. Fatigue can have physical or mental causes. Recent studies points at that functional fatigue such as Myalgic encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS), also known chronic fatigue and immune dysfunction syndrome (CFIDS) may have its cause by the altered intestinal microbiota of the patient since some of the intestinal microbes actually can secrete neurotransmitters such as dopamine.
• Functional fatigue is the transient inability of a muscle to maintain optimal physical performance, and mental fatigue is a transient decrease in maximal cognitive performance resulting from prolonged periods of cognitive activity.
• sequelae as a consequence of fatigue are also en- compassed by the definition of treatment, alleviation, stabilization or prophylaxis of fatigue.
• Sequelae that are associated with fatigue, in particular prolonged fatigue are e.g. chronic fatigue, which may be a symptom of many diseases and conditions known to the skilled person.
• the mammal experience a decreased fatigue, and/or increased energy, physical and/or mentally, by administering one dose daily of the fermented composition (or the substance) according to the present invention for 30 days or less, such as 25 days or less, e.g. 20 days or less, such as 15 days or less, e.g. 10 days or less, such as 5 days or less, e.g. 3 days or less, such as 2 days or less, e.g. 1 days or less.
• the fermented composition (or the sub- stance) for the treatment, alleviation, stabilization or prophylaxis of fatigue may preferably comprise a high content of one or more lactic acid bacterial strains and a high content of beta-glucans, polysaccharides, oligosaccharides, proteoglycans and/or glycoproteins originating from one or more fermented materials of one or more of species of oat, species of barley and/or species of fungus, in particular fungus selected from mushrooms, more particularly edible species of mushrooms, such as discussed above, and which is combined with dried or dried and fermented material originating from one or more species of seaweed, micro algae and/or macro algae.
• IBD Inflammatory bowel disease
• IBD is a group of inflammatory conditions of the die- tary tract, in particular, the colon and small intestine.
• Diarrhoea, duodenitis, ileitis, jejunitis, cholitis, sigmoiditis, morbus Crohn's disease, and/or cholitis ulcerosa are the principal symptoms and types of inflammatory bowel disease.
• inflammatory diseases such as Crohn's disease, affect the small intestine and large intestine, it can also affect the mouth, esophagus, stomach and the anus whereas ulcerative coli- tis primarily affects the colon and the rectum.
• sequelae as a consequence of inflammatory bowel disease are also encompassed by the definition of treatment, alleviation, stabilization or prophylaxis of inflammatory bowel disease.
• Sequelae that are associated with inflammatory bowel disease are arthritis, in particular Psoreatic Arthritis and spondyloartropaties and Morbus Bechterew ( 4:Van prate et al. Ann Rheum Diseases 2013 72: 414-7; 5:Mielants H et al J Rheumatol 1995; 22 2273-8) pyoderma gangrenosum, primary sclerosing cholangitis, and non-thyroidal illness syndrome (NTIS).
• NTIS non-thyroidal illness syndrome
• Gastric bypass operation refers to a surgical procedure in which the size of the stomach is reduced by being divided into a small upper pouch and a much larger lower "remnant" pouch and then the small intestine is rearranged to connect to both.
• the operation may normally be prescribed to treat morbid obesity (defined as a body mass index greater than 40), and/or avoiding regaining weight after a gastric bypass surgery procedure, type 2 diabetes, hypertension, sleep apnoea, and other comorbid conditions.
• morbid obesity defined as a body mass index greater than 40
• type 2 diabetes hypertension
• sleep apnoea hypertension
• sleep apnoea and other comorbid conditions.
• the intestinal mucosal microbiome has been proven to be site specific; this means that the removal of a part of the intestine, causes lack of the site specific normal microflora. Therefore, a patient who has been subjected to gastric bypass has to be on a life-long diet with food additives.
• treatment of diarrhea in an embodiment of the present invention may be obtained by administering one dose daily of the fermented composition (or the substance) according to the present invention within 5 days or less, such as 4 days or less, e.g. 3 days or less, such as 2 days or less, e.g. 1 days or less, such as 20 hours or less, e.g. 15 hours or less, such as 10 hours or less, e.g. 5 hours or less, such as within 2 hours or less.
• IBD Inflammatory bowel disease
• treatment of diarrhoea in a mammal relates to the subjective opinion of the mammal of the improved health and/or the objective inspection of the stool obtained from the mammal, e.g. using the Bristol Stool Chart.
• alleviation of diarrhoea in a mammal may be obtained by administering one dose daily of the fermented composition (or the substance) according to the present invention within 5 days or less, such as 4 days or less, e.g. 3 days or less, such as 2 days or less, e.g. 1 days or less, such as 20 hours or less, e.g. 15 hours or less, such as 10 hours or less, e.g. 5 hours or less, such as within 2 or less.
• the term "alleviation of diarrhoea in a mammal” relates to the subjective opinion of the mammal of the improved health and/or the objective inspection of the stool obtained from the mammal, e.g. using the Bristol Stool Chart.
• the fermented composition (or the substance) for the treatment, alleviation, stabilisation or prophylaxis of inflammatory bowel disease may preferably comprise a high content of one or more lactic acid bac- terial strains and a high content of beta-glucans, polysaccharides, oligosaccharides, proteoglycans and/or glycoproteins originating from one or more fermented materials of one or more species of oat, species of barley and/or species of fungus, in particular fungus selected from edible mushrooms, more particularly edible mushrooms of species, such as discussed above which is combined with dried or dried and fermented material originating from one or more species of seaweed, micro algae and/or macro algae.
• the fermented composition (or substance) according to the present invention has surprisingly shown to be effective against bacterial infection.
• the fermented composition (or the substance) may be used for the treatment, alleviation, stabilization or prophylaxis of bacterial infection and may preferably comprise a combination of oat, barley and/or edible fungi, such as discussed above and seaweed/algae.
• the term "bacterial infection” relates to infections caused by either gram positive bacteria or gram negative bacteria.
• the bacterial infection referred to in the present invention may be caused by gram positive bacteria, in particular Staphylococcus, preferably Staphylococcus aureus, and/or Clostridium, preferably Clostridium perfringens.
• one such bacterial infection may be a staphylococcus infection, in particular a Staphylococcus aureus infection, which may results in e.g. fumnculosis, or even worse in chronic fumnculosis.
• Fumnculosis is most common in animals, such as dogs or cats, but it may also occur in humans.
• Animals and humans suffering from fumnculosis may develop fumncle, which is a deep folliculitis (an infection and inflammation of one or more hair follicles).
• Furuncles are bumpy, red, pus-filled lumps around a hair follicle that are tender, warm, and very painful. They range from pea-sized to golf ball-sized. A yellow or white point at the center of the lump can be seen when the boil is ready to drain or discharge pus.
• a severe infection an individual may experience fever, swollen lymph nodes, and fatigue.
• Furuncles may appear on the buttocks or near the anus, the back, the neck, the stomach, the chest, the arms, legs or feet, or even in the ear canal.
• Staphylococcus aureus may spread to different parts of the body via the bloodstream (bacteremia), causing bacterial infections (or sequelaes) like wound infections, abscesses, osteomyelitis, endocarditis, or pneumonia that may severely harm or even kill the infected animal or human.
• bacteremia causing bacterial infections (or sequelaes) like wound infections, abscesses, osteomyelitis, endocarditis, or pneumonia that may severely harm or even kill the infected animal or human.
• Staphylococcus aureus strains may also produce enzymes and exotoxins that likely cause or increase the severity of certain diseases. Such diseases are also considered sequelae as a consequence of bacterial infection and are also encompassed by the definition of treatment, alleviation, stabilisation or prophylaxis of bacterial infection, and include food poisoning, septic shock, toxic shock syndrome, and scalded skin syndrome. Almost any organ system can be infected by Staphylococcus aureus.
• Clostridium infection may be a Clostridium infection, which may results in e.g. food poisoning, sepsis or myonecrosis, such as gas gangrene.
• the Clostridium infec- tion may in particular be caused by Clostridium perfringens.
• Myonecrosis e.g. gas gangrene
• Myonecrosis is a condition of necrotic damage, specific to muscle tissue. It is often seen in infections with Clostridium perfringens that cause myonecrosis by producing alpha toxins.
• This alpha toxin is a lethal toxin and also known as phospholipase C (lecithinase). It increases vascular permeability and produces necrotizing activity.
• the toxins secreted are very powerful and destroy nearby tissue and generating gas at the same time.
• Bacterial infections in mammals e.g.
• the fermented composition (or the substance) according to the pre- sent invention may preferably comprise a fermented composition having a high content of one or more lactic acid bacterial strains and a high content of beta-glucans, polysaccharides, oligosaccharides, proteoglycans and/or glycoproteins, the latter originating from one or more fermented materials of one or more species of oat, species of barley and/or species of fungus, in particular fungus selected from mushrooms, more particularly edible species of mushrooms, such as already discussed above, which is combined with a dried or dried and fermented material originating from one or more species of seaweed, micro algae and/or macro algae, or said substance comprises a fermented composition as described above, or as being obtainable by a method as described above.
• the fermented composition (or the substance) is administered to a mammal (an animal or a human) in combination with one or more drugs in order to avoid the bacterial infection; the bacterial infection side effects; or the side effects many medications may have.
• a patient which is treated with antibiotics may experience diarrhea, because the intestinal microflora is also affected by the antibiotics administered to the patient.
• antibiotics e.g. penicillines, erytromy- cines, macrolides (azithromycin or roxithromycin), gentamycins and/or fungicides to fight an infection from pathogenic microorganisms
• the patient may be given the fer- meted composition according to the present invention.
• the combination of prebiotics, in particular ⁇ -glucans, and probiotics stimulates the regeneration of a healthy intestinal microflora, and thus reduces, eliminates symptoms, e.g. diarrhea, which arise from treatment with antibiotics; or the period in which the patient suffers from such symp- toms is reduced significantly in relation to a situation where administration is not followed by the administration of the fermented composition as mentioned above.
• bacterial infections in a mammal such as bacterial infections caused by Staphylococcus aureus and/or by Clostridium difficile/perfringens, may be avoided by a prophylactic treatment with the fermented composition according to the present invention.
• bacterial infections in a mammal such as bacterial infections caused by Staphylococcus aureus and/or by Clostridium difficile/perfringens
• the individual, human or animal takes a daily dose of the fermented composition regularly, in particular a dose daily, over a period, such as at least one week.
• one dose or a single dose relates to 50 gram fermented product according to the present invention or less, such as 40 g or less, e.g. 30 gram or less, such as 25 gram or less, e.g. 20 gram or less, e.g. 15 gram or less, such as 10 gram or less or 5 gram.
• the dose is preferably a unit daily dose, which is taken in one dose.
• a daily dose may be divided into two or more smaller doses, e.g. by dividing a daily dose of 15 gram into 3 doses of 5 g each, which are taken at 3 different times at the day.
• the substance and/or the fermented composition may be used as an adjuvant product accompanied by one or more other drugs.
• certain antibodies such as sekukinumab, usteokinumab
• certain interleukines in particular IL17, IL19 and/or IL21
• Anti-interleukines are frequently used in the treatment of certain inflammatory arthritis diseases, such as pso- reasisrtritis, Spondylartritis, and/or Morbus Bechterew (4,5).
• the present invention also relates to a combinational product comprising:
• the fermented composition and/or the substance may comprise a dual function within the combined product according to the present invention.
• the dual function may in a first aspect lie in treating, stabilising and/or alleviating and/or in a second aspect lie in the prophylaxis of diseases, conditions and/or injuries in a mammal. It should be noted that embodiments and features described in the context of one of the aspects of the present invention also apply to the other aspects of the invention.
• treatment refers to the use of an agent, such as the substance or the fermented composition according to the present invention, in an attempt to cure or mitigate a disease, a condition, or an injury in a mammal.
• the term "alleviation" used in the present invention refers to the action of an agent, such as the substance or the fermented composition according to the present invention, to reduce or eliminate symptoms in a mammal of a disease, a condition or an injury.
• prophylaxis refers to the use of an agent, such as the substance or the fermented composition according to the present invention, in an attempt to prevent a disease, a condition or an injury in a mammal and/or for the protective treatment of a mammal.
• stabilising refers to the use of an agent, such as the substance or the fermented composition according to the present invention, to stabilise the intestinal flora in a mammal for the improvement of the well being (e.g. prevent, treat or alleviate a disease, a condition or an injury in a mammal).
• stabilising used in the present invention refers to the use of an agent, such as the substance or the fermented composition according to the present invention, to stabilise, normalise and fight infected intestinal flora in a mammal.
• Example 1 Preparation of a fermented composition according to the present tion.
• Table 2 composition of Fermented material.
• a Composition as shown in Table 1 is poured into a fermentation tank and the moisture content was adjusted to about 40% humidity.
• the mixture was inoculated with a combination lactic acid-producing bacteria: Pediococcus pentosaceus, Pediococcus acidilactici and Lactobacillus plantarum (delivered by Chr. Hansen).
• the ingredients were mixed at room temperature and the temperature was slowly increased from the heat generated from the fermentation to a steady state temperature of about 42°C. After 20 hours of fermentation the fermentation broth had a pH of 4.3.
• the resulting fermented composition was subjected to spin flash drying in order to protect the lactic acid bacteria and keep a high number of viable cells.
• ⁇ -glucans induced a 17-20% increase in activated CD 19+ B lymphocytes (a pre -B-cell) on when compared to controls made on tests using cells from the same donor. Incubation and exposure of the cells to ⁇ -glucans were made in a stable constant atmosphere at physiological conditions in a ViVoX TC Biosystem, invented by ViVoX ApS.
• the test was carried out on white blood cells (Buffycoat) harvested from healthy blood donors.
• a person suffering from chronic oligo arthritis antigen HLA B27-associated was test- ed and showed a CRP level of above 20, as seen on the test dates preceeding 01/06/2015 in fig. 1.
• the test person was prescribed a daily dose of 5 g of the fermented product according to example 1.
• the CRP level was lowered to a level below 8 after administering the daily dose of the fermented composition in a period of more than 14 days after 01/08/2015. After interrupting the administration of the fermented composition for another 14 days, the CRP level again rose to a level above 8 as shown on fig. 1. The CRP level then again dropped to a level of below 8 when resuming the administration of the daily dose.
• F-calprotectin was lowered from 50 to 30, i.e. 40% lower, in the period taking the fermented product compared to periods where the product was not taken.
• F-Calprotectin (Faeces Calprotectin) comprises as much as 60% of the soluble protein content of neutrophil cytosol and is secreted by an unknown mechanism during inflammation. Faecal calprotectin was here used to detect intestinal inflammation, and serves as a marker for inflammatory bowel diseases.
• test persons After 6 months, the test persons all showed a weight loss of between 3 to 1 1 kg., see table 3.
• a female test person (Person no. 6 in table 2) who had undergone a gastric bypass four years earlier, before initiating the test was prescribed a daily dose of 5 g of the fermented product according to example 1 during a period of 6 months.
• Example 6 The test person was instructed in continuing her usual diet during the test period. After the end of the test period there was not observed any significant increase in weight.
• Example 6 The test person was instructed in continuing her usual diet during the test period. After the end of the test period there was not observed any significant increase in weight.
• Toll like Receptor 4-induced Interleukin 1 Defines the intestinal Microbiome and Mucosal Immune Response in Arthritis-Prone IL-1 Receptor Antagonist Deficient Mice, S. Abdollahi-Roodsaz, ACR conference speech Boston Nov. 2014.
• Arabinogalactan proteins have deep roots in eukaryotes: identification of genes and epitopes in brown algae and their role in Fucus serratus embryo development

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