WO2021191469A1 - Composition pour le traitement d'un dysfonctionnement gastro-intestinal et/ou de morbidités associées - Google Patents

Composition pour le traitement d'un dysfonctionnement gastro-intestinal et/ou de morbidités associées Download PDF

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Publication number
WO2021191469A1
WO2021191469A1 PCT/EP2021/058185 EP2021058185W WO2021191469A1 WO 2021191469 A1 WO2021191469 A1 WO 2021191469A1 EP 2021058185 W EP2021058185 W EP 2021058185W WO 2021191469 A1 WO2021191469 A1 WO 2021191469A1
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composition
gastro
derivative
intestinal dysfunction
present
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PCT/EP2021/058185
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English (en)
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Ute Obermueller-Jevic
Stefan Ruedenauer
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Basf Se
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • 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
    • A61K31/01—Hydrocarbons
    • 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
    • A61K31/01—Hydrocarbons
    • A61K31/015—Hydrocarbons carbocyclic
    • 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
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/07—Retinol compounds, e.g. vitamin A
    • 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
    • A61K31/12—Ketones
    • A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • 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
    • A61K31/702—Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
    • 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

Definitions

  • Composition for the treatment of gastro-intestinal dysfunction and/or associated morbidities thereto is provided.
  • the present invention relates to compositions and methods of treatment and/or prevention of gastro intestinal dysfunction and/or associated morbidities thereto.
  • the present invention relates to compositions comprising at least two components selected from at least one human milk oligosaccharide (HMO), at least one C3-C4-alkane carboxylic acid, and at least one carotenoid.
  • HMO human milk oligosaccharide
  • C3-C4-alkane carboxylic acid at least one carotenoid.
  • Gastro-intestinal dysfunction is a medical condition of a subject which is characterized by an abnormal function of the gastro-intestinal system. Commonly used methods for diagnosing gastro intestinal dysfunction are barium swallow, endoscopy, colonoscopy, biopsies, and abdominal x-ray.
  • the gastro-intestinal system includes all structures between the mouth and the anus, forming a continuous passageway that includes the main organs of digestion, namely, the mouth, stomach, duodenum, jejunum, ileum, caecum, colon, rectum and anus.
  • the gastro intestinal system varies in their organ composition depending on species.
  • the gastro-intestinal tract takes in via oral application foods or feeds, beverages and water as nourishment.
  • the gastro intestinal tract takes in via oral or rectal application pharmaceutical or other preparations to prevent and/or treat conditions and diseases.
  • a further mode of application is tube feeding which is used only in gastro-intestinal dysfunction.
  • Gastro-intestinal function involves physiologic processes providing nutrition and medication, barrier function and immune defenses as well as formation and deposition of feces.
  • the gastro-intestinal system produces and/or releases substances required for digestion and absorption including mucous, gastric fluid, bile fluid, pancreatic fluid.
  • HCL water
  • enzymes such as lipases, amylases, proteinases and the like
  • hormones such as gastrin, cholecystokinin, secretin, vasoactive intestinal polypeptide, glucose-dependent insulinotropic hormone, bombesin, enteroglucagon, ghrelin, glucagon-like peptide 1 , glucagon-like peptide 2, leptin, motilin, neurotensin, pancreatic polypeptide, peptide YY, somatostatin and the like, intrinsic factor, bile acids.
  • the gastro-intestinal system conducts regular bowel movements.
  • the gastro intestinal system collates metabolites of carbohydrate, protein, fat, purine, porphyrin metabolism, as well as products resulting from detoxification processes as well as other substances for excretion.
  • the gastro-intestinal system hosts the microbiota, mainly in the colon, which consists of trillions of microbes including some 4,000 strains of bacteria, viruses and fungi living in communities.
  • the community composition depends on their organ-specific and lumen-specific location, as well on diet composition, environmental and host factors.
  • the microbiota consumes indigestible fibers and produces metabolites which impacts gastro-intestinal function and health.
  • Gastro-intestinal dysfunction results due to disturbance of digestion and absorption processes; disturbance of motility; disturbance of barrier function and immune system; disturbance of formation and deposition of feces.
  • the underlying mechanisms may include infections with pathogenic bacteria, viruses and fungi; dysbalanced microbiota; toxins from foods or other sources; auto immune processes and impaired immune system; acute and chronic inflammation; nutritional deficiencies; endocrinal dysfunction; liver and gall bladder dysfunction; neuro-muscular dysfunction; biochemical or structural causes, idiopathic or due to other causes.
  • a small percentage of all people have an inherited form of gastrointestinal dysfunction.
  • Symptoms of gastro-intestinal dysfunction are vomiting of food or blood, bloating, flatulence, distension, more frequent stools, diarrhea, fewer or hardened stools, constipation, reflux, maldigestion, malabsorption, abdominal pain, abdominal cramps, bleedings, unusual discharges, blood in stool, weakness, fatigue, weight loss, fever, collapse.
  • Gastrointestinal dysfunction is often linked with a number of different conditions and/or diseases in the gastro-intestinal system (see Table 1).
  • IBS Irritable bowel syndrome
  • Lifestyle changes are often not sufficient to achieve the desired improvement of gastro-intestinal function and medications to treat infections (antibiotics), inflammation (prednisone) or immunomodulators (azathioprine, methotrexate, infliximab, adalimumab, certolizumab, vedolizumab, ustekinumab, natalizumab) are usually required. In some cases, even surgery is performed.
  • the present invention provides in a first aspect a composition I comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally iii) at least one carotenoid; or a composition II comprising i) at least one HMO, and ii) at least one carotenoid, and optionally iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof; or a composition III comprising i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one carotenoid, and optionally iii) at least one HMO.
  • compositions I, II or III for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto.
  • compositions I, II or III for use in the treatment or prevention of gastro-intestinal dysfunction.
  • compositions I, II or III for use in the treatment or prevention of morbidities associated to gastro-intestinal dysfunction.
  • the present invention relates to methods for treating a subject having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities.
  • the present invention relates to methods for treating a subject having, being suspected of having or being at risk of developing gastro-intestinal dysfunction.
  • the present invention relates to methods for treating a subject having, being suspected of having or being at risk of developing morbidities associated to gastro-intestinal dysfunction.
  • the present invention relates to a nutritional supplement or a functional food comprising said compositions I, II or III.
  • compositions I, II or III are related to the use of said compositions I, II or III as a nutritional supplement or a functional food, in particular in the dietary management of gastrointestinal dysfunction and/or associated morbidities.
  • compositions I, II or III are related to the use of said compositions I, II or III as a nutritional supplement or a functional food, in particular in the dietary management of gastrointestinal dysfunction.
  • compositions I, II or III are related to the use of said compositions I, II or III as a nutritional supplement or a functional food, in particular in the dietary management of morbidities associated to gastro-intestinal dysfunction.
  • the present invention relates to a kit for the pharmaceutical use or dietary management use comprising individually the components of said compositions I, II or III, respectively.
  • HMOs can be combined with C3-C4-alkane carboxylic acids or derivatives thereof, and optionally with at least one carotenoid. Such compositions provide beneficial effects as described herein.
  • composition I comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally iii) at least one carotenoid.
  • HMO refers to human milk oligosaccharide(s). These carbohydrates are resistant to enzymatic hydrolysis by digestive enzymes (e.g. pancreatic and/or brush border).
  • digestive enzymes e.g. pancreatic and/or brush border.
  • HMOs are found in the human breast milk. Each individual HMO is based on a combination of glucose, galactose, sialic acid (N-acetylneuraminic acid), fucose and/or N-acetylglucosamine with many and varied linkages between them. So far over 130 such structures have been identified in human milk.
  • the HMOs can be acidic (e.g. charged sialic acid containing oligosaccharide) or neutral (e.g. fucosylated oligosaccharide).
  • the HMO is selected from the group of fucosylated oligosaccharides, N-acetylated oligosaccharides and sialylated oligosaccharides.
  • the HMO is a "fucosylated oligosaccharide". These are HMOs having a fucose residue. It has a neutral nature. Some examples are 2'-FL (2'-fucosyllactose), 3-FL (3-fucosyllactose), difucosyllactose, lacto-N-fucopentaose (e.g.
  • lacto-N- fucopentaose I lacto- N-fucopentaose II, lacto-N-fucopentaose III, lacto-N-fucopentaose V)
  • lacto-N-fucohexaose lacto-N- difucohexaose I, fucosyllacto-N-hexaose, fucosyllacto- N-neohexaose, difucosyllacto-N-hexaose I, difucosyllacto-N-neohexaose II and any combination thereof.
  • the fucosylated oligosaccharide is selected from the group comprising 2’-FL, 3-FL and difucosyllactose (e.g. 2’,2”-DiFL and/or 3, 2’-DiFL).
  • the fucosylated oligosaccharide is 2’-FL.
  • the HMO is a ”N-acetylated oligosaccharide.
  • the term ”N-acetylated oligosaccharide(s)” encompasses both "N-acetyl-lactosamine” and "oligosaccharide(s) containing N-acetyl-lactosamine". They are neutral oligosaccharides having an N-acetyl-lactosamine residue. Suitable examples are LNT (lacto-N-tetraose), para-lacto-N- neohexaose (para-LNnH), LNnT (lacto-N-neotetraose) or any combination thereof.
  • N-acetylated oligosaccharide is selected from the group of LNT and LNnT.
  • the HMO is a ’’sialylated oligosaccharide.
  • the term ’’sialylated oligosaccharide encompasses an oligosaccharide having a sialic acid residue. It has an acidic nature. Some examples are 3’-SL (3'-sialyllactose) and 6’-SL (6'-sialyllactose). In a preferred embodiment the sialylated oligosaccharide is 6’-SL.
  • the HMO is selected from the group comprising 2’-FL, 3-FL, difucosyllactose (e.g. 2’,2”-DiFL and/or 3, 2’-DiFL), LNT, LNnT, 3’-SL and 6’-SL and/or any combination thereof.
  • the HMO is selected from the group comprising 2’-FL, difucosyllactose (e.g. 2’,2”-DiFL and/or 3,2’-DiFL), LNT, LNnT and 6’-SL and/or any combination thereof.
  • the HMO is selected from the group comprising 2’-FL, LNT, LNnT and 6'-SL and/or any combination thereof.
  • C3-C4-alkane carboxylic acid or derivative thereof encompasses propionic acid, n-butyric acid and iso-butyric acid (2-methyl propionic acid) as well as derivatives thereof and/or any mixture thereof.
  • Suitable derivatives are salts, esters and amides, in particular physiologically acceptable ones.
  • physiologically acceptable salts are alkali salts, like sodium or potassium salts, or alkaline-earth salts, like magnesium or calcium salts, or choline salts.
  • physiologically acceptable salts are alkali salts, in particular sodium salts or potassium salts, especially sodium salts.
  • physiologically acceptable esters are those derived from C1-C6 alcohols, in particular those derived from monohydric C1-C6 alcohols, e.g. those derived from methanol or ethanol, or dihydric C1-C6 alcohols, like those derived from 1 ,2-ethandiol, or C1-C4 alkoxy substituted monohydric alcohols, like those derived from 2-methoxyethanol, 2-ethoxyethanol or 2-butoxyethanol.
  • Other examples for physiologically acceptable esters are glycerides, like mono-, di-, or triglycerides, in particular mono- or diglycerides.
  • the physiologically acceptable esters are those derived from monohydric C1-C6 alcohols, e.g. those derived from methanol or ethanol, or mono- or diglycerides.
  • physiologically acceptable amides are those derived from mono- or di-C1-C6-alkyl amines.
  • the C3-C4 alkane carboxylic acid is provided as physiologically acceptable derivative thereof; in particular the derivative is a physiologically acceptable salt, e.g. a sodium salt or potassium salt, or a mixture thereof, or a physiologically acceptable ester, e.g. said ester is derived from C1 -C6 alcohols, in particular a mono-or a dihydric C1 -C6 alcohol, or said ester is a mono- or diglyceride, or a mixture thereof.
  • the C3-C4-alkane carboxylic acid or derivative thereof is sodium propionate or potassium propionate or sodium butyrate or potassium butyrate or a mixture thereof. Especially, it is sodium propionate or sodium butyrate or a mixture thereof.
  • the C3-C4-alkane carboxylic acid or derivative thereof is propionic acid or a derivative thereof, in particular it is a physiologically acceptable salt of propionic acid, especially it is sodium propionate or potassium propionate, or a physiologically acceptable ester of propionic acid, especially methyl propionate or ethyl propionate or propionic acid monoglyceride or propionic acid diglyceride, particularly ethyl propionate or propionic acid monoglyceride.
  • the C3-C4-alkane carboxylic acid or derivative thereof is sodium propionate or potassium propionate.
  • the C3-C4-alkane carboxylic acid or derivative thereof is butyric acid or a derivative thereof, in particular it is a physiologically acceptable salt of butyric acid, especially it is sodium butyrate or potassium butyrate, or a physiologically acceptable ester of butyric acid, especially methyl butyrate or ethyl butyrate or butyric acid monoglyceride or butyric acid diglyceride, particularly ethyl butyrate or butyric acid monoglyceride.
  • the C3-C4- alkane carboxylic acid or derivative thereof is sodium butyrate or potassium butyrate.
  • the at least one C3-C4-alkane carboxylic acid or derivative thereof is a mixture of propionic acid and butyric acid or derivatives thereof, in particular it is a mixture of physiologically acceptable salts of propionic acid and butyric acid, especially it is a mixture of sodium propionate and sodium butyrate or a mixture of potassium propionate and potassium butyrate, or a mixture of physiologically acceptable esters of propionic acid and butyric acid, especially a mixture of methyl propionate and methyl butyrate, or a mixture of ethyl propionate and ethyl butyrate, or a mixture of propionic acid monoglyceride and butyric acid monoglyceride, or a mixture of propionic acid diglyceride and butyric acid diglyceride, particularly a mixture of ethyl propionate and ethyl butyrate or a mixture of propionic acid monoglyceride and butyric acid monoglyceride.
  • the at least one C3-C4-alkane carboxylic acid or derivative thereof is a mixture of sodium propionate and sodium butyrate or a mixture of potassium propionate and potassium butyrate.
  • the term “carotenoid” relates to at least one carotenoid selected from the group consisting of astaxanthin, alpha-carotene, beta-carotene, beta-cryptoxanthin, lycopene, lutein, meso-zeaxanthin and zeaxanthin.
  • the carotenoid is at least one selected from the group consisting of beta-carotene, lycopene, lutein and meso-zeaxanthin or mixtures thereof, particularly it is beta-carotene and/or lutein, especially it is beta-carotene.
  • composition I comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • composition I comprises i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate.
  • composition I does not comprise one or more carotenoids.
  • composition I comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and iii) at least one carotenoid.
  • composition I comprises i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and iii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene.
  • the composition I comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally iii) at least one carotenoid, wherein the ratio of the at least one HMO (component A) and the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof (component B) is from 100 : 1 to 1 : 100, preferably from 20: 1 to 1 :20, more preferably 10:1 to 1 :10, even more preferably from 3: 1 to 1 :3, in particular 2:1 to 1 :2.
  • the composition I comprises as at least one C3-C4- alkane carboxylic acid or derivative(s) thereof a mixture of propionic acid or a derivative thereof and butyric acid or a derivative thereof, in a ratio of from 100 : 1 to 1 : 100, preferably from 20:1 to 1 : 20, more preferably from 10:1 to 1 :15, even more preferably from 2: 1 to 1 :8.
  • the at least one HMO and the at least one C3-C4- alkane carboxylic acid or derivative(s) thereof are present in synergistic amounts.
  • composition I does not comprise one or more carotenoids.
  • the composition I comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and iii) at least one carotenoid, wherein the ratio of the at least one HMO (component A) and the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof (component B) is from 100 :1 to 1 : 100, preferably from 20:1 to 1 :20, more preferably 10:1 to 1 :10, even more preferably from 3: 1 to 1 :3, in particular 2:1 to 1 :2, and/or wherein the ratio of the at least one HMO (component A) and the at least one carotenoid (component C) is from 1 : 1 to 200000: 1 , and/or wherein the ratio of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof (component B) and the at least one carotenoid
  • said composition I comprises as at least one C3-C4- alkane carboxylic acid or derivative(s) thereof a mixture of propionic acid or a derivative thereof and butyric acid or a derivative thereof, in a ratio of from 100 : 1 to 1 : 100, preferably from 20: 1 to 1 : 20, more preferably from 10:1 to 1 :15, even more preferably from 2:1 to 1 :8.
  • the at least one HMO and the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof are present in synergistic amounts.
  • the at least one HMO and the at least one the carotenoid are present in synergistic amounts.
  • the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof and the at least one carotenoid are present in synergistic amounts.
  • the at least one HMO, the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof and the at least one carotenoid are present in synergistic amounts.
  • the total amount of the at least one HMO and the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally the at least one carotenoid is from 1 to 100 wt% of the total composition I, preferably from 10 to 100 wt%.
  • the total amount of the at least one HMO is from 10 to 90 wt% of the total composition I, preferably from 20 to 80 wt%, more preferably from 30 to 70 wt%, even more preferably from 40 to 60 wt%. In yet another embodiment the total amount of the at least one HMO is from 5 to 50 wt% of the total composition I, preferably from 8 to 40 wt%, more preferably from 10 to 35 wt%, even more preferably from 15 to 30 wt%. In yet another embodiment the total amount of the at least one HMO is from 50 to 95 wt% of the total composition I, preferably from 55 to 80 wt%, more preferably from 60 to 75 wt%.
  • the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 10 to 90 wt% of the total composition I, preferably from 15 to 85 wt%, more preferably from 20 to 75 wt%, even more preferably from 25 to 60 wt%. In yet another embodiment the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 10 to 50 wt% of the total composition I, preferably from 15 to 45 wt%, more preferably from 20 to 35 wt%.
  • the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 50 to 90 wt% of the total composition I, preferably from 55 to 80 wt%, more preferably from 60 to 75 wt%.
  • the total amount of the at least one carotenoid is from 0.0005 to 50 wt% of the total composition I, preferably from 0.005 to 5.0 wt%, more preferably from 0.05 to 0.5 wt%, even more preferably from 0.5 to 4 wt%, even more preferably from 0.1 to 4 wt%, even more preferably from 0.1 to 3 wt%, even more preferably from 0.1 to 2 wt%, even more preferably from 0.1 to 1 wt%.
  • composition I can further comprise one or more vitamins or related compounds thereto.
  • vitamins and related compounds thereto include vitamin A (e.g. retinol, retinyl acetate, retinyl palmitate, retinyl stearate, retinyl esters with other long-chain unsaturated fatty acids, retinal, retinoic acid and the like), vitamin B1 (e.g. thiamine, thiamine pyrophosphate, TPP, thiamine triphosphate, TTP, thiamine hydrochloride, thiamine mononitrate and the like), vitamin B2 (e.g.
  • vitamin B3 e.g. nicotinic acid, nicotinamide, nicotinamide adenine dinucleotide (NAD), nicotinic acid mononucleotide (NicMN), pyridine-3-carboxylic acid and the like, as well as the vitamin B3-precursor tryptophan
  • pantothenic acid e.g. pantothenate, panthenol and the like
  • vitamin B6 e.g.
  • pyridoxine pyridoxal, pyridoxamine, pyridoxine hydrochloride and the like
  • biotin folic acid (e.g. folate, folacin, pteroylglutamic acid and the like)
  • vitamin B12 e.g. cobalamin, methylcobalamin. deoxyadenosyl- cobalamin, cyanocobalamin, hydroxycobalamin, adenosylcobalamin and the like
  • vitamin E e.g.
  • alpha-, beta-, gamma- and/or delta-tocopherol alpha-, beta-, gamma- and/or delta-tocopherol acetate, alpha-, beta-, gamma- and/or delta-tocopherol succinate, alpha-, beta-, gamma- and/or delta-tocopherol nicotinate, alpha-, beta-, gamma- and/or delta tocotrienol and the like), vitamin K (e.g. vitamin K2, vitamin K1 , phylloquinone, naphthoquinone, vitamin K3, menadione, and the like ), vitamin C (ascorbic acid), vitamin D (e.g. calciferol, cholecalciferol, 1 ,25-dihydroxyvitamin D, ergocalciferol and the like), and the like and/or mixtures thereof.
  • vitamin K e.g. vitamin K2, vitamin K1 , phylloquinone
  • composition I does not comprise one or more carotenoids.
  • composition I does comprise one or more carotenoids.
  • composition does not comprise one or more vitamins or related compounds thereto.
  • the composition I can further comprise one or more medium-chain fatty acids.
  • These medium-chain fatty acids may be provided as free fatty acids, as glycerides (e.g. as monoglycerides, diglycerides or triglycerides and/or as mixtures thereof), as phospholipids, as alkyl esters and/or as mixtures thereof, preferably as glycerides, more preferably as triglycerides or alkyl esters.
  • Examples of medium-chain fatty acids include caproic acid, caprylic acid, capric acid, lauric acid and the like and /or mixtures thereof.
  • composition I does not comprise one or more carotenoids.
  • composition I does comprise one or more carotenoids.
  • composition I does not comprise one or more medium-chain fatty acids.
  • composition I can further comprise one or more long-chain fatty acids.
  • long-chain fatty acids may be provided as free fatty acids, as glycerides (e.g. as monoglycerides, diglycerides or triglycerides and/or as mixtures thereof), as phospholipids, as alkyl esters and/or as mixtures thereof, preferably as glycerides, more preferably as triglycerides or as alkyl esters.
  • long chain fatty acids include saturated long chain fatty acids (e.g.
  • linoleic acid linoelaidic acid, alpha-linolenic acid, arachidonic acid, eicosapentaenoic acid, docosapentenoic acid, docosahexaenoic acid and the like and/or mixtures thereof) and/or mixtures thereof.
  • These long chain fatty acids are comprised for example in vegetable oils, single cell oils and marine oils, e.g. fish oil, krill oil and the like.
  • composition I does not comprise one or more carotenoids.
  • composition I does comprise one or more carotenoids.
  • composition I does not comprise one or more long-chain fatty acids.
  • composition I can further comprise one or more prebiotics.
  • prebiotics include water-insoluble fibers (e.g. lignin, cellulose, hemi- cellulose, resistant starch, xanthum gum and the like and/or mixtures thereof), water-soluble fibers (e.g.
  • arabinoxylan arabinoxylan, inulin, pectin, alginic acid and derivatives thereof, agar, carrageen, raffinose, xylose, polydextrose, lactulose, xylooligosaccharides, fructooligosaccharides, galactooligo- saccharides, isomalto-oligosaccharides and the like and/or mixtures thereof) and the like and/or mixtures thereof.
  • composition I does not comprise one or more carotenoids.
  • composition I does comprise one or more carotenoids.
  • composition I does not comprise one or more prebiotics.
  • composition I can further comprise one or more probiotics.
  • probiotics optionally present in the composition I of the present invention include microorganisms or parts thereof of the family Lactobacillaceae, e.g. of the genus Lactobacillus (e.g. the species lactobacillus acidophilus, lactobacillus alimentarius, lactobacillus casei, lactobacillus delbrueckii (like lactobacillus delbrueckii spp. bulgaricus, lactobacillus delbrueckii spp.
  • Bifidobacterium e.g. the species bifidobacterium animalis, bifidobacterium bifidum, bifidobacterium breve, bifidobacterium infantis, bifidobacterium lactis, bifidobacterium longum and the like
  • Pediococcus e.g. the species bifidobacterium animalis, bifidobacterium bifidum, bifidobacterium breve, bifidobacterium infantis, bifidobacterium lactis, bifidobacterium longum and the like
  • Pediococcus e.g.
  • Lactococcus e.g. the species lactococcus lactis (like lactococcus latis spp. cremoris, lactococcus lactis spp. lactic and the like
  • composition I does not comprise one or more carotenoids.
  • composition I does comprise one or more carotenoids.
  • composition I does not comprise one or more probiotics.
  • composition I can further comprise one or more phenolic compounds.
  • phenolic compounds include monophenols (e.g. apiole, carnosol, carvacrol, dillapiole, rosemarinol and the like), flavonoids (e.g.
  • quercetin kaempferol, myricetin, fisetin, rutin, isorhamnetin, hesperidin, naringenin, silybin, eriodyctiol, acacetin, apigenin, chrysin, diosmetin, tangeritin, luteolin, catechins like epigallocatechin gallate, theaflavin, thearubigins, proanthocyanidins, pelargonidin, peonidin, cyanidin, delphinidin, malvidin, petunidin and the like), isoflavonoids (e.g.
  • daidzein genistein, glycitein and the like
  • aurones chalconoids
  • flavonolignans lignans
  • phytoestrogens stilbenoids (e.g. resveratrol, pterostilbene, piceatannol and the like)
  • curcuminoids e.g. curcumin and the like
  • tannins aromatic acids (e.g. salicylic acid, vanillic acid, gallic acid, ellagic acid, tannic acid, caffeic acid, chlorogenic acid, cinnamic acid, ferulic acid, coumarin and the like), phenylethanoids (e.g. tyrosol, hydroxytyrosol, oleocanthal, oleuropein and the like ), capsaicin, gingerol, alkylresorcinol and the like and/or mixtures thereof.
  • aromatic acids e.g. salicylic acid, vanillic acid, gallic acid
  • composition I does not comprise one or more carotenoids.
  • composition I does comprise one or more carotenoids.
  • composition I does not comprise one or more phenolic compounds.
  • composition I can further comprise one or more herbals, e.g. known from Chinese diets, Indian diets, Mediterranean diets and the like. These herbals can be provided as powders obtained from the plant and/or fungus or parts thereof or as extracts thereof.
  • herbals e.g. known from Chinese diets, Indian diets, Mediterranean diets and the like. These herbals can be provided as powders obtained from the plant and/or fungus or parts thereof or as extracts thereof.
  • herbals known from Chinese diets include extracts or powders of hawthorn fruit, wolfberry, spatholobus stem, caterpillar fungus, cloud mushroom, crysanthemum, honeysuckle flower, mulberry leaf, glossy privet fruit, malaytea scurfpea fruit, cherokee rose fruit, palmleaf raspberry fruit, Chinese magnoliavine fruit, reishi mushroom, ephedra, epimedium, Angelica root, Astragalus root, rhubarb, licorice, morinda root, notoginseng, white peony root, American ginseng, fleeceflower root, kudzu root, rehmannia root, salvia root, Chinese yam, wild buckwheat rhizome, tall gastrodia tuber, golden root, Cassia seed, Coix seed, Dodder seed and the like and/or mixtures thereof.
  • herbals known from Indian diets include extracts or powders of Amalaki (Indian gooseberry), Haritaki (chebulic myrobalan), Bibhitaki (beleric), Haldi (turmeric), Tulsi (holy basil), Shigru (moringa), Twak (cinnamon), Yashtimadhu (licorice root), Dhanyaka (coriander), Ashwagandha (winter cherry), Kumkuma (saffron), Manjistha (Indian madder), Brahmi (bacopa), Neem (margosa), Ajwain (Bishop’s weed), Elaichi (cardamom), Shikakai (Acacia concinna), Shatavari (wild asparagus), Jeera (cumin), Guduchi (tinospora) and the like and/or mixtures thereof.
  • Examples for herbals known from Mediterranean diets include extracts or powders of rosemary, basil, parsley, saffron, thyme, oregano, sage, cilantro, lemon, orange, grape, grapeseed, fig, blueberry, raspberry, strawberry, cherry, fennel, sesame seeds, pine seeds, garlic, onion, ginger root, pepper, chili and the like, olive oil and/or mixtures thereof.
  • composition I does not comprise one or more carotenoids.
  • composition I does comprise one or more carotenoids. In another embodiment of the present invention the composition I does not comprise one or more herbals.
  • composition I can further comprise one or more minerals.
  • minerals include such ones comprising calcium, phosphorous, iodine, iron, magnesium, copper, zinc, manganese, chlorine, potassium, sodium, selenium, chromium, molybdenum and the like and/or mixtures thereof. Minerals are usually added in salt form.
  • composition I does not comprise one or more carotenoids.
  • composition I does comprise one or more carotenoids.
  • composition I does not comprise one or more minerals. In a further embodiment of the present invention the composition I does not comprise a mineral comprising iron.
  • composition I does not comprise one or more antibodies.
  • compositions I of the present invention can be prepared by mixing the at least one HMO, and the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, optionally the at least one carotenoid, and optionally further components e.g. vitamins and related compounds thereto, further carotenoids, medium chain fatty acids, long chain fatty acids, prebiotics, probiotics, phenolic compounds, herbals, minerals and the like and/or mixtures thereof, as known in the art.
  • the composition I does not comprise more than 80 wt% water.
  • the present invention provides a composition I which comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally iii) at least one carotenoid, for use as a medicament, preferably as a medicament for mammals, birds, crustaceans and/or fishes, in particular as a medicament for mammals.
  • the term ’’mammals encompasses humans and nonhuman mammals.
  • non-human mammals are livestock, e.g. sheep, goats, pigs, cattles, horses, camels, llamas and the like, and pets, e.g. cats, dogs and the like.
  • the composition I is for use as a medicament for humans.
  • composition I is for use as a medicament for livestock and/or pets.
  • composition I is for use as a medicament for birds, e.g. poultry (like chickens, ducks, geese, turkeys and the like) and ornamental birds (like canaries and the like).
  • birds e.g. poultry (like chickens, ducks, geese, turkeys and the like) and ornamental birds (like canaries and the like).
  • composition I is for use as a medicament for fishes, e.g. fishes used for consumption (like salmon, tuna, sardines, cod, trout, and the like) and ornamental fishes (like kois and the like).
  • fishes e.g. fishes used for consumption (like salmon, tuna, sardines, cod, trout, and the like) and ornamental fishes (like kois and the like).
  • composition I is for use as a medicament for crustaceans, e.g. crustaceans used for consumption (like crabs, lobsters, crayfish, shrimps, prawns, krill and the like) and ornamental crustaceans (like crabs, lobsters, crayfish, shrimps, prawns, krill and the like).
  • crustaceans used for consumption (like crabs, lobsters, crayfish, shrimps, prawns, krill and the like) and ornamental crustaceans (like crabs, lobsters, crayfish, shrimps, prawns, krill and the like).
  • compositions I of the present invention for use as a medicament can be administered orally, enterally or parenterally, preferably orally.
  • composition I for use as a medicament is an orally administrable composition.
  • the composition I comprises i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and optionally iii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, for use as a medicament, preferably as a medicament for humans.
  • composition I shall be applicable for the compositions I for use as a medicament and the specific embodiments thereto.
  • the present invention provides a composition I which comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally iii) at least one carotenoid, for the use in the treatment and/or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto, preferably of mammals, more preferably of humans.
  • the term ’’treatment” in the context of gastro-intestinal dysfunction and/or associated morbidities thereto means using an effective therapy or management to alleviate, reduce or cure the condition and/or disease (gastro-intestinal dysfunction and/or associated morbidities thereto) and/or symptoms thereof, as the case may be, in addition it also includes the stabilization of the condition and/or disease, as the case may be, in order not to worsen in the course of the respective condition and/or disease.
  • treatment is understood as using an effective therapy or management to stabilize, alleviate or reduce the condition and/or disease and/or symptoms thereof, as the case may be.
  • gastro-intestinal dysfunction and/or associated morbidities thereto means an effective therapy or management so that the condition and/or disease (gastro-intestinal dysfunction and/or associated morbidities thereto) does not de novo develop, manifest and/or symptoms thereof do not occur.
  • composition I is for use in the treatment of gastro intestinal dysfunction and/or associated morbidities thereto.
  • composition I is for use in the prevention of gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the term ’’gastro-intestinal dysfunction refers to a condition and/or disease, as the case may be, which is characterized by an abnormal function of the gastro intestinal system of a respective subject.
  • a person with gastro-intestinal dysfunction has a disturbance of digestion and absorption processes; disturbance of motility; disturbance of barrier function and immune system; disturbance of formation and deposition of feces.
  • composition I is for use in the treatment or prevention of gastro-intestinal dysfunction of a human.
  • associated morbidities as well as the term ’’morbidities associated to” mean one or more conditions and/or diseases which are co-occurring to the primary condition or disease (gastro-intestinal dysfunction), or which are occurring later in the life of the subject who had earlier in his or her life said primary condition and/or disease (gastro intestinal dysfunction).
  • composition I is for use in the treatment or prevention of an associated morbidity, e.g. an associated morbidity of the esophagus, which includes functional chest pain, functional heartburn, reflux hypersensitivity, globus, functional dysphagia, esophagitis, esophageal ulceration, esophageal cancer etc.
  • an associated morbidity of the stomach which includes functional dyspepsia, belching disorders, nausea, vomiting, rumination syndrome, dyspepsia, malnutrition, pernicious anemia, gastritis, gastroenteritis, diarrhea, Crohn’s disease, gastric stenosis, gastric ulcers, gastric cancer etc.
  • an associated morbidity of the small intestine which includes maldigestion, malnutrition, enteritis, enterocolitis, necrotizing enterocolitis diarrhea, constipation, Coeliac disease, tropical sprue, inflammatory bowel disease (IBD) which includes Crohn’s disease,
  • composition I is for use in the treatment or prevention of an associated morbidity of the esophagus, in particular of a human subject having gastro-intestinal dysfunction.
  • composition I is for use in the treatment or prevention of functional chest pain, functional heartburn, reflux hypersensitivity, globus, functional dysphagia, esophagitis, esophageal ulceration, esophageal cancer, in particular of a human subject having gastro-intestinal dysfunction.
  • composition I is for use in the treatment or prevention of an associated morbidity of the stomach, in particular of a human subject having gastro intestinal dysfunction.
  • composition I is for use in the treatment or prevention of functional dyspepsia, belching disorders, nausea, vomiting, rumination syndrome, dyspepsia, malnutrition, pernicious anemia, gastritis, gastroenteritis, diarrhea, Crohn’s disease, gastric stenosis, gastric ulcers, gastric cancer, in particular of a human subject having gastro intestinal dysfunction.
  • composition I is for use in the treatment or prevention of an associated morbidity of the small intestine, in particular of a human subject having gastro-intestinal dysfunction.
  • composition I is for use in the treatment or prevention of maldigestion, malnutrition, enteritis, enterocolitis, necrotizing enterocolitis diarrhea, constipation, Coeliac disease, tropical sprue, inflammatory bowel disease (IBD) which includes Crohn’s disease, ulcerative colitis and other inflammatory diseases, vitamin deficiency, mineral deficiency, trace element deficiency, fatty acid deficiency, amino acid deficiency, intestinal ulcers, intestinal cancer, in particular of a human subject having gastro-intestinal dysfunction.
  • IBD inflammatory bowel disease
  • composition I is for use in the treatment or prevention of an associated morbidity of the large intestine, in particular of a human subject having gastro-intestinal dysfunction.
  • composition I is for use in the treatment or prevention of diverticulitis, colitis, pseudomembranous colitis, diarrhea, constipation, irritable bowel syndrome (IBS), inflammatory bowel disease which includes Crohn’s disease, ulcerative colitis and other inflammatory diseases, colo-rectal ulcers, colo-rectal cancer, in particular of a human subject having gastro-intestinal dysfunction.
  • IBS irritable bowel syndrome
  • composition I for use in the treatment or prevention of gastro-intestinal dysfunction is an orally administrable composition, in particular for a human subject.
  • composition I for use in the treatment or prevention of morbidities associated to gastro-intestinal dysfunction is an orally administrable composition, in particular for a human subject.
  • the composition I comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto, in particular of a mammal, especially of gastro-intestinal dysfunction of a human or especially of morbidities associated to gastro-intestinal dysfunction.
  • composition I comprises i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto of a mammal, in particular of gastro-intestinal dysfunction of a human, or in particular of morbidities associated to gastro-intestinal dysfunction of a human.
  • the composition I for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto, in particular of a mammal, especially of gastro-intestinal dysfunction of a human or especially of morbidities associated to gastro-intestinal dysfunction of a human does not comprise one or more carotenoids.
  • the composition I comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and iii) at least one carotenoid, for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto of a mammal, in particular of gastro-intestinal dysfunction of a human, or in particular of morbidities associated to gastro-intestinal dysfunction of a human.
  • the composition I comprises i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and iii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto of a mammal, in particular of gastro-intestinal dysfunction of a human, or in particular of morbidities associated to gastro-intestinal dysfunction of a human.
  • composition I shall be applicable for the compositions I for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto and the specific embodiments thereto.
  • the present invention provides a method to treat a subject having a disease, in particular gastro-intestinal dysfunction and/or associated morbidities thereto, or to prevent a subject being suspected of having or being at risk of developing a disease, in particular gastro-intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the composition I which comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally iii) at least one carotenoid.
  • the composition I which comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally iii) at least one carotenoid.
  • said method is for treating a subject having gastro-intestinal dysfunction, in particular a human, or preventing a subject being suspected of having or being at risk of developing gastro-intestinal dysfunction, in particular a human.
  • said method is for treating a subject having morbidities associated to gastro-intestinal dysfunction, in particular a human, or preventing a subject being suspected of having or being at risk of developing morbidities associated to gastro-intestinal dysfunction, in particular a human.
  • said human subject is in the age of 12 years or older, preferably 18 years or older, more preferably 35 years or older, in particular 50 years or older, even more particular 60 years or older.
  • composition I can be administered, preferably orally, or that any of the “at least one HMO” and the “at least one C3-C4-alkane carboxylic acid or derivative(s) thereof’ and optional the “at least one carotenoid” and optional further components can be administered separately, preferably orally.
  • composition I comprises as the at least one HMO two or more HMOs these can be administered separately, preferably orally, and in case composition I comprises as the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof two or more C3-C4-alkane carboxylic acid or derivative(s) thereof these can be administered separately, preferably orally, and in case composition I comprises as the at least one carotenoid two or more carotenoids these can be administered separately, preferably orally.
  • the daily application rate of the at least one HMO is from 0.1 to 20.0 g, preferably from 1.0 to 15.0 g, more preferably from 2.0 to 10.0 g, in particular from 2.5 to 5.0 g.
  • the daily application rate of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 0.1 to 10.0 g, preferably from 1.0 to 9.0 g, more preferably from 1.2 to 9.0 g, in particular from 2.0 to 8.0 g, especially from 2.5 to 6.0 g.
  • the propionic acid and/or a derivative thereof can be administered in an application rate from 0.1 to 6.0 g/day, preferably from 0.5 to 5.0 g/day, more preferably from 1 .0 to 4.0 g/day.
  • the butyric acid and/or a derivative thereof can be administered in an application rate from 0.1 to 9.0 g/day, preferably from 0.5 to 7.0 g/day, more preferably from 1 .0 to 5.0 g/day.
  • the daily application rate of propionic acid and/or a derivative thereof is from 0.1 to 4.0 g
  • the daily application rate of butyric acid and/or a derivative thereof is from 0.1 to 6.0 g
  • the daily application rate of propionic acid and/or a derivative thereof is from 0.5 to 4.0 g
  • the daily application rate of butyric acid and/or a derivative thereof is from 0.5 to 5.0 g
  • the daily application rate of propionic acid and/or a derivative thereof is from 1.0 to 3.0 g
  • the daily application rate of butyric acid and/or a derivative thereof is from 1.5 to 4.0 g.
  • the daily application rate of the at least one carotenoid is from 0.1 to 100 mg, preferably from 5 to 50 mg.
  • the present invention provides a method to treat a subject having a disease, in particular gastro-intestinal dysfunction and/or associated morbidities thereto, or to prevent a subject being suspected of having or being at risk of developing a disease, in particular gastro intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the composition I which comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • the present invention provides a method to treat a subject having a disease, in particular gastro-intestinal dysfunction and/or associated morbidities thereto, or to prevent a subject being suspected of having or being at risk of developing a disease, in particular gastro intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the composition I which comprises i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate.
  • the composition I which comprises i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate.
  • the present invention provides a method to treat a subject having a disease, in particular gastro-intestinal dysfunction and/or associated morbidities thereto, or to prevent a subject being suspected of having or being at risk of developing a disease, in particular gastro- intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of said composition I which does not comprise one or more carotenoids.
  • the present invention provides a method to treat a subject having a disease, in particular gastro-intestinal dysfunction and/or associated morbidities thereto, or to prevent a subject being suspected of having or being at risk of developing a disease, in particular gastro intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the composition I which comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and iii) at least one carotenoid.
  • the composition I which comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and iii) at least one carotenoid.
  • the present invention provides a method to treat a subject having a disease, in particular gastro-intestinal dysfunction and/or associated morbidities thereto, or to prevent a subject being suspected of having or being at risk of developing a disease, in particular gastro intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the composition I which comprises i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and iii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene.
  • the composition I which comprises i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and ii
  • composition I shall be applicable for the use of the composition I in this method accordingly and in the specific embodiments thereto.
  • the present invention provides the use of a composition I, comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally iii) at least one carotenoid, for the manufacture of a medicament, preferably for the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides the use of a composition I, comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, for the manufacture of a medicament, preferably for the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto.
  • a composition I comprising i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, for the manufacture of a medicament, preferably for the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides the use of a composition I, which does not comprise one or more carotenoids, for the manufacture of a medicament, preferably for the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides the use of a composition I, comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and iii) at least one carotenoid, for the manufacture of a medicament, preferably for the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides the use of a composition I comprising i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and iii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, for the manufacture of a medicament, preferably for the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the medicament manufactured as mentioned above is for treating a subject having gastro-intestinal dysfunction, in particular a human, or preventing a subject being suspected of having or being at risk of developing gastro-intestinal dysfunction, in particular a human.
  • the medicament manufactured as mentioned above is for treating a subject having morbidities associated to gastro-intestinal dysfunction, in particular a human, or preventing a subject being suspected of having or being at risk of developing morbidities associated to gastro-intestinal dysfunction, in particular a human.
  • the present invention provides a nutritional supplement comprising a composition I which comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally iii) at least one carotenoid.
  • the term “nutritional supplement” means a manufactured product intended to supplement a diet, in particular of subjects having, being suspected of having or being at risk of gastro-intestinal dysfunction and/or associated morbidities thereto.
  • nutritional supplements include “dietary supplements” and “medical foods”.
  • a dietary supplement is intended to supplement a diet, in particular of subjects having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto, however it needs not to be used under medical supervision.
  • a medical food is also intended to supplement a diet, in particular of subjects having, being suspected of having or being at risk of developing gastro intestinal dysfunction and/or associated morbidities thereto, but it is under medical supervision.
  • the terms “medical foods” and “food for special medical purpose” are interchangeable.
  • the nutritional supplement can comprise said composition I or that the nutritional supplement can comprise any of the “at least one HMO” and the “at least one C3-C4-alkane carboxylic acid or derivative(s) thereof’ and optional the “at least one carotenoid” and optional further components in separate form.
  • the nutritional supplement is a dietary supplement.
  • the nutritional supplement is a medical food.
  • the nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro intestinal dysfunction and/or associated morbidities thereto.
  • the nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro intestinal dysfunction.
  • the nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to gastro-intestinal dysfunction.
  • the daily application rate of the at least one HMO is from 0.1 to 20.0 g, preferably from 1.0 to 15.0 g, more preferably from 2.0 to 10.0 g, in particular from 2.5 to 5.0 g.
  • the daily application rate of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is 0.1 to 10.0 g, preferably from 1.0 to 9.0 g, more preferably from 1.2 to 9.0 g, in particular from 2.0 to 8.0 g, especially from 2.5 to 6.0 g..
  • propionic acid and/or a derivative thereof can be administered in an application rate from 0.1 to 6.0 g/day, preferably from 0.5 to 5.0 g/day, more preferably from 1 .0 to 4.0 g/day.
  • butyric acid and/or a derivative thereof can be administered in an application rate from 0.1 to 9.0 g/day, preferably from 0.5 to 7.0 g/day, more preferably from 1.0 to 5.0 g/day.
  • the daily application rate of propionic acid and/or a derivative thereof is from 0.1 to 4.0 g
  • the daily application rate of butyric acid and/or a derivative thereof is from 0.1 to 6.0 g
  • the daily application rate of propionic acid and/or a derivative thereof is from 0.5 to 4.0 g
  • the daily application rate of butyric acid and/or a derivative thereof is from 0.5 to 5.0 g
  • the daily application rate of propionic acid and/or a derivative thereof is from 1 .0 to 3.0 g
  • the daily application rate of butyric acid and/or a derivative thereof is from 1 .5 to 4.0 g.
  • the daily application rate of the at least one carotenoid is from is from 0.1 to 100 mg, preferably from 5 to 50 mg.
  • said subject is a human, preferably in the age of 12 years or older, more preferably 18 years or older, even more preferably 35 years or older, in particular 50 years or older, even more in particular 60 years or older.
  • the nutritional supplement can be administered, preferably orally, or that any of the “at least one HMO” and the “at least one C3-C4-alkane carboxylic acid or derivative(s) thereof’ and the optional “at least one carotenoid” and optional further components can be administered separately, preferably orally.
  • the nutritional supplement comprises as the at least one HMO two or more HMOs these can be administered separately, preferably orally, and in case the nutritional supplement comprises as the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof two or more C3-C4-alkane carboxylic acid or derivative(s) thereof these can be administered separately, preferably orally, and in case the nutritional supplement comprises as the at least one carotenoids two or more carotenoids these can be administered separately, preferably orally.
  • the present invention provides a nutritional supplement comprising a composition I which comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides a nutritional supplement comprising a composition I which comprises i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • a composition I which comprises i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides a nutritional supplement comprising a composition I which does not comprise one or more carotenoids, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides a nutritional supplement comprising a composition I which comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and iii) at least one carotenoid, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides a nutritional supplement comprising a composition I which comprises i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and iii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene
  • a composition I which comprises i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and iii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene
  • said nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro intestinal dysfunction.
  • said nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to gastro-intestinal dysfunction. It is understood that the embodiments mentioned for the composition I as well as those mentioned for gastro-intestinal dysfunction and morbidities associated to gastro-intestinal dysfunction shall be applicable for the nutritional supplement accordingly and as well as to the specific embodiments thereto.
  • the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the nutritional supplement which comprises a composition I, comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally iii) at least one carotenoid.
  • a composition I comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally iii) at least one carotenoid.
  • said method is for the dietary management of a subject having, being suspected of having or being at risk of developing gastro-intestinal dysfunction.
  • said method is for the dietary management of a subject having, being suspected of having or being at risk of developing morbidities associated to gastro-intestinal dysfunction.
  • the nutritional supplement can comprise said composition I or that the nutritional supplement can comprise any of the “at least one HMO” and the “at least one C3-C4-alkane carboxylic acid or derivative(s) thereof’ and optional the “at least one carotenoid” and optional further components in separate form.
  • composition I comprises as the at least one HMO two or more HMOs
  • these can be administered separately, preferably orally
  • composition I comprises as at the least one C3-C4-alkane carboxylic acid or derivative(s) thereof two or more C3-C4-alkane carboxylic acid or derivative(s) thereof
  • these can be administered separately, preferably orally
  • composition I comprises as the at least one carotenoid two or more carotenoids
  • the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the nutritional supplement which comprises a composition I, comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the nutritional supplement which comprises a composition I, comprising i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate.
  • a composition I comprising i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate.
  • the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the nutritional supplement which comprises a composition I, which does not comprise one or more carotenoids.
  • the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the nutritional supplement which comprises a composition I, comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and iii) at least one carotenoid.
  • a composition I comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and iii) at least one carotenoid.
  • the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the nutritional supplement which comprises a composition I, comprising i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and iii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially it is beta-carotene.
  • a composition I comprising i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and iii) as component C beta-carotene, lycopen
  • said method is for the dietary management of a subject having, being suspected of having or being at risk of developing gastro-intestinal dysfunction.
  • said method is for the dietary management of a subject having, being suspected of having or being at risk of developing morbidities associated to gastro-intestinal dysfunction.
  • the present invention provides the use of a composition I, comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally iii) at least one carotenoid, for the manufacture of a nutritional supplement, preferably for the dietary management of subjects having, being at risk or developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides the use of a composition I, comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, for the manufacture of a nutritional supplement, preferably for the dietary management of subjects having, being at risk or developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides the use of a composition I, comprising i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, for the manufacture of a nutritional supplement, preferably for the dietary management of subjects having, being at risk or developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides the use of a composition I, which does not comprise one or more carotenoids, for the manufacture of a nutritional supplement, preferably for the dietary management of subjects having, being at risk or developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides the use of a composition I, comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and iii) at least one carotenoid, for the manufacture of a nutritional supplement, preferably for the dietary management of subjects having, being at risk or developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides the use of a composition I, comprising i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and iii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially it is beta-carotene, for the manufacture of a nutritional supplement, preferably for the dietary management of subjects having, being at risk or developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • a composition I comprising i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and iii) as component C beta-carotene, lycopene, lutein and/or meso
  • the nutritional supplement manufactured as mentioned above is for the dietary management of a subject having gastro-intestinal dysfunction, in particular a human, or a subject being suspected of having or being at risk of developing gastro-intestinal dysfunction, in particular a human.
  • the nutritional supplement manufactured as mentioned above is for the dietary management of a subject having gastro-intestinal dysfunction, in particular a human, or a subject being suspected of having or being at risk of developing gastro-intestinal dysfunction, in particular a human.
  • composition I shall be applicable for the use of the composition I in this use accordingly and in the specific embodiments thereto.
  • Both, the medicament (in general and for the respective specific use) and the nutritional supplement (in general and for the respective specific use) of the present invention can be delivered in any suitable format.
  • Formulations suitable for oral administration may be in the form of capsules, tablets, pills, dragees, lozenges (using a flavored basis, usually sucrose and acacia or tragacanth), powders, granules, and the like or as a solution or a suspension in an aqueous or non-aqueous liquid, or as an oil-in-water or water-in-oil liquid emulsion, or as an elixir or syrup, or as pastilles (using an inert base, such as gelatin and glycerin, or sucrose and acacia), each comprising a predetermined amount of the at least one HMO, the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, optional the at least one carotenoid and optional further components.
  • the medicament in general and for the
  • active ingredients of said medicament and nutritional supplement can be delivered together in a respective suitable format or that each of component A and component B and optionally component C can be delivered in a respective format or that each of the active ingredients can be delivered in a respective format, or any combination thereof.
  • the desired components of the composition I may be mixed with one or more pharmaceutically acceptable carriers, such as sodium citrate or dicalcium phosphate, and/or any of the following: (1) fillers or extenders, such as starches, lactose, sucrose, glucose, mannitol, and/or silicic acid; (2) binders, such as carboxymethylcellulose, alginates, gelatin, polyvinyl pyrrolidone, sucrose and/or acacia; (3) humectants, such as glycerol; (4) disintegrating agents, such as agar- agar, calcium carbonate, potato or tapioca starch, alginic acid, certain silicates, and sodium carbonate; (5) solution retarding agents, such as paraffin; (6) absorption accelerators, such as quaternary ammonium compounds; (7) wetting agents, such as acetriglyceride
  • powders and/or granules can be reconstituted with water or another aqueous liquid prior to consumption.
  • the so obtained liquid does not comprise more than 80 wt% water.
  • liquid formulations do not comprise more than 80 wt% water.
  • the present invention provides a functional food comprising a composition I which comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally iii) at least one carotenoid.
  • the term “functional food” means a food which is fortified with the composition I according to the present invention and intended to be used in a diet, in particular of subjects having, being suspected of having or being at risk of developing gastro intestinal dysfunction and/or associated morbidities thereto.
  • the terms “functional food” and “fortified food” are interchangeable.
  • Examples for foods being suitable for the preparation of functional foods are (1) dairy products e.g. yogurt, dessert, smoothie, milk and the like or mixtures thereof; (2) bakery products e.g. bread, rolls, pasta, cookie, cake, cereal bar and the like or mixtures thereof; (3) candy products e.g. candies, gummies, chewing gum, chocolate, pudding, cookie and the like or mixtures thereof; (4) beverage products e.g. fruit juice, vegetable juice, lemonade, water and the like or mixtures thereof.
  • dairy products e.g. yogurt, dessert, smoothie, milk and the like or mixtures thereof
  • bakery products e.g. bread, rolls, pasta, cookie, cake, cereal bar and the like or mixtures thereof
  • candy products e.g. candies, gummies, chewing gum, chocolate, pudding, cookie and the like or mixtures thereof
  • beverage products e.g. fruit juice, vegetable juice, lemonade, water and the like or mixtures thereof.
  • the functional food can comprise said composition I or that the functional food can comprise any of the “at least one HMO” and the “at least one C3-C4-alkane carboxylic acid or derivative(s) thereof’ and optional the “at least one carotenoid” and optional further components in separate form.
  • composition I comprises as the at least one HMO two or more HMOs these can be comprised separately in the functional food or together as composition
  • composition I comprises as the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof two or more C3-C4-alkane carboxylic acid or derivative(s) thereof these can be comprised separately in the functional food or together as composition
  • composition I comprises as the at least one carotenoid two or more carotenoids these can be comprised separately in the functional food or together as composition.
  • the functional food is for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the functional food is for use in the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to gastro-intestinal dysfunction.
  • the daily application rate of the at least one HMO is from 0.1 to 20.0 g, preferably from 1.0 to 15.0 g, more preferably from 2.0 to 10.0 g, in particular from 2.5 to 5.0 g.
  • the daily application rate of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is 0.1 to 10.0 g, preferably from 1.0 to 9.0 g, more preferably from 1.2 to 9.0 g, in particular from 2.0 to 8.0 g, especially from 2.5 to 6.0 g.
  • propionic acid and/or a derivative thereof can be administered in an application rate from 0.1 to 6.0 g/day, preferably from 0.5 to 5.0 g/day, more preferably from 1 .0 to 4.0 g/day.
  • butyric acid and/or a derivative thereof can be administered in an application rate from 0.1 to 9.0 g/day, preferably from 0.5 to 7.0 g/day, more preferably from 1.0 to 5.0 g/day.
  • the daily application rate of propionic acid and/or a derivative thereof is from 0.1 to 4.0 g
  • the daily application rate of butyric acid and/or a derivative thereof is from 0.1 to 6.0 g
  • the daily application rate of propionic acid and/or a derivative thereof is from 0.5 to 4.0 g
  • the daily application rate of butyric acid and/or a derivative thereof is from 0.5 to 5.0 g
  • the daily application rate of propionic acid and/or a derivative thereof is from 1 .0 to 3.0 g
  • the daily application rate of butyric acid and/or a derivative thereof is from 1 .5 to 4.0 g.
  • the daily application rate of the at least one carotenoid is is from 0.1 to 100 g, preferably from 5 to 50 mg.
  • said subject is a human, preferably in the age of 12 years or older, more preferably 18 years or older, even more preferably 35 years or older, in particular 50 years or older, even more in particular 60 years and older.
  • the present invention provides a functional food comprising a composition I which comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides a functional food comprising a composition I which comprises i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • a composition I which comprises i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides a functional food comprising a composition I which does not comprise one or more carotenoids, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides a functional food comprising a composition I which comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and iii) at least one carotenoid.
  • the present invention provides a nutritional food comprising a composition I which comprises i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and iii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially it is beta-carotene.
  • said functional food is for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro intestinal dysfunction.
  • said functional food is for use in the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to gastro-intestinal dysfunction.
  • the present invention provides a method for the dietary management of a subject having, being suspected to have or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the functional food which comprises a composition I, comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally iii) at least one carotenoid.
  • a composition I comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally iii) at least one carotenoid.
  • said method is for the dietary management of a subject having, being suspected of having or being at risk of developing gastro-intestinal dysfunction.
  • said method is for the dietary management of a subject having, being suspected of having or being at risk of developing morbidities associated to gastro-intestinal dysfunction.
  • the “at least one HMO” and the “at least one C3-C4-alkane carboxylic acid or derivative(s) thereof’ and optional the “at least one carotenoid” and optional further components can be comprised separately in the functional food or together as composition.
  • composition I comprises as the at least one HMO two or more HMOs these can be comprised separately in the functional food or together as composition
  • composition I comprises as the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof two or more C3-C4-alkane carboxylic acid or derivative(s) thereof these can be comprised separately in the functional food or together as composition
  • composition I comprises as at the least one carotenoid two or more carotenoids these can be comprised separately in the functional food or together as composition.
  • the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the functional food which comprises a composition I, comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of a functional food which comprises a composition I, comprising i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate.
  • a functional food which comprises a composition I, comprising i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate.
  • the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the functional food which comprises a composition I, which does not comprise one or more carotenoids.
  • the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the functional food which comprises a composition I, comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and iii) at least one carotenoid.
  • a composition I comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and iii) at least one carotenoid.
  • the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the functional food which comprises a composition I, comprising i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and iii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially it is beta-carotene.
  • said method is for the dietary management of a subject having, being suspected of having or being at risk of developing gastro-intestinal dysfunction.
  • said method is for the dietary management of a subject having, being suspected of having or being at risk of developing morbidities associated to gastro-intestinal dysfunction.
  • the present invention provides the use of a composition I, comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally iii) at least one carotenoid, for the manufacture of a functional food, preferably for the dietary management of subjects having, being at risk or developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides the use of a composition I, comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, for the manufacture of a functional food, preferably for the dietary management of subjects having, being at risk or developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides the use of a composition I, comprising i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, for the manufacture of a functional food, preferably for the dietary management of subjects having, being at risk or developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides the use of a composition I, which does not comprise one or more carotenoids, for the manufacture of a functional food, preferably for the dietary management of subjects having, being at risk or developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides the use of a composition I, comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and iii) at least one carotenoid, for the manufacture of a functional food, preferably for the dietary management of subjects having, being at risk or developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides the use of a composition I, comprising i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and iii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, for the manufacture of a functional food, preferably for the dietary management of subjects having, being at risk or developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • a composition I comprising i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and iii) as component C beta-carotene, lycopene, lutein and/or meso-ze
  • the functional food manufactured as mentioned above is for the dietary management of a subject having gastro-intestinal dysfunction, in particular a human, or a subject being suspected of having or being at risk of developing gastro-intestinal dysfunction, in particular a human.
  • the nutritional supplement manufactured as mentioned above is for the dietary management of a subject having morbidities associated to gastro-intestinal dysfunction, in particular a human, or a subject being suspected of having or being at risk of developing morbidities associated to gastro-intestinal dysfunction, in particular a human.
  • composition I shall be applicable for the use of the composition I in this use accordingly and in the specific embodiments thereto.
  • the functional food of the present invention can be prepared by known techniques and it can have any suitable type of format such as (1) a dairy product e.g. yogurt, dessert, smoothie, milk and the like or mixtures thereof; (2) a bakery product e.g. bread, rolls, pasta, cookie, cake, cereal bar and the like or mixtures thereof; (3) a candy product e.g. candies, gummies, chewing gum, chocolate, pudding, cookie and the like or mixtures thereof; (4) a beverage product e.g. fruit juice, vegetable juice, lemonade, water and the like or mixtures thereof.
  • a dairy product e.g. yogurt, dessert, smoothie, milk and the like or mixtures thereof
  • a bakery product e.g. bread, rolls, pasta, cookie, cake, cereal bar and the like or mixtures thereof
  • a candy product e.g. candies, gummies, chewing gum, chocolate, pudding, cookie and the like or mixtures thereof
  • (4) a beverage product e.g. fruit juice, vegetable juice, lemonade
  • composition I the composition I for use as a medicament, the composition I for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto, the nutritional supplement and the functional food, in particular for use in the dietary management of gastro-intestinal dysfunction and/or associated morbidities thereto, respectively, as disclosed herein, can be co-administered to subjects receiving at least one pharmaceutical against said gastro-intestinal dysfunction and/or associated morbidities thereto.
  • Examples for pharmaceuticals used in the treatment of gastro-intestinal dysfunction are:
  • - immunomodulators azathioprine, methotrexate, infliximab, adalimumab, certolizumab, vedolizumab, ustekinumab, natalizumab and the like
  • the present invention provides a method to treat a subject having gastro-intestinal dysfunction and/or associated morbidities thereto, by administering to the subject a) an effective amount of a composition I, a composition I for use as a medicament, a composition I for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto, a nutritional supplement or a functional food, in particular for use in the dietary management of gastro-intestinal dysfunction and/or associated morbidities thereto, which comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally iii) at least one carotenoid; and b) an effective amount of at least one pharmaceutical suitable to treat said gastro-intestinal dysfunction and/or associated morbidities thereto, in particular, wherein the application rate of the at least one pharmaceutical suitable to treat said gastro-intestinal dysfunction and/or associated morbidities thereto is reduced compared to a treatment with the at least one pharmaceutical alone.
  • gastro-intestinal dysfunction and/or associated morbidities thereto is gastro-intestinal dysfunction and the pharmaceutical is
  • antibiotic cefaclor, cefuroxime, penicillin, amoxicillin and the like
  • an anti-inflammatory drug prednisone and the like
  • an immunomodulator azathioprine, methotrexate, infliximab, adalimumab, certolizumab, vedolizumab, ustekinumab, natalizumab and the like.
  • the present invention provides a composition
  • a composition comprising a) i) at least one HMO, and/or ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and/or iii) at least one carotenoid; and b) an effective amount of at least one pharmaceutical, in particular for use as a medicament, especially for use in the treatment of the gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides a composition
  • a composition comprising a) i) as component A 2’-FL, and/or ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and/or sodium butyrate, and/or iii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene; and b) an antibiotic (like cefaclor, cefuroxime, penicillin, amoxicillin and the like), an anti-inflammatory drug (like prednisone and the like), and/or an immunomodulator (like azathioprine, methotrexate, infliximab, adalimumab, certolizumab, vedolizumab, ustekinumab, natalizumab and the like) in a pharmaceutical effective amount
  • the present invention provides a composition
  • a composition comprising a) as component A at least one HMO, preferably 2’-FL, and b) an antibiotic (like cefaclor, cefuroxime, penicillin, amoxicillin and the like), an anti-inflammatory drug (like prednisone and the like), and/or an immunomodulator (like azathioprine, methotrexate, infliximab, adalimumab, certolizumab, vedolizumab, ustekinumab, natalizumab and the like) in a pharmaceutical effective amount, without any C3-C4-alkane carboxylic acid or derivative(s) thereof, in particular for use as a medicament, especially for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto.
  • an antibiotic like cefaclor, cefuroxime, penicillin, amoxicillin and the like
  • an anti-inflammatory drug like prednisone and the like
  • the present invention provides a composition
  • a composition comprising a) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and/or sodium butyrate, and b) an antibiotic (like cefaclor, cefuroxime, penicillin, amoxicillin and the like), an anti-inflammatory drug (like prednisone and the like), and/or an immunomodulator (like azathioprine, methotrexate, infliximab, adalimumab, certolizumab, vedolizumab, ustekinumab, natalizumab and the like) in a pharmaceutical effective amount, without any HMO, in particular for use as a medicament, especially for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto.
  • an antibiotic like cefaclor, cefuroxime, penicillin, amoxicillin and the like
  • an anti-inflammatory drug like prednisone and the like
  • the present invention provides a composition
  • a composition comprising a) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, and b) an antibiotic (like cefaclor, cefuroxime, penicillin, amoxicillin and the like), an anti-inflammatory drug (like prednisone and the like), and/or an immunomodulator (like azathioprine, methotrexate, infliximab, adalimumab, certolizumab, vedolizumab, ustekinumab, natalizumab and the like) in a pharmaceutical effective amount, without any C3-C4-alkane carboxylic acid or derivative(s) thereof and/or without HMO, in particular for use as a medicament, especially for use in the treatment or prevention for of gastro-intestinal dysfunction and/or associated morbidities there
  • the composition I the composition I for use as a medicament, the composition I for use in the treatment or prevention of gastro-intestinal dysfunction, the nutritional supplement or a functional food, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro-intestinal dysfunction, especially of subjects having gastro-intestinal dysfunction, used in said method comprises 2’-FL, and/or propionic acid and/or butyric acid or derivative(s) thereof, and/or beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably 2’-FL, sodium propionate and sodium butyrate, and/or optionally preferably beta-carotene and/or lutein, especially beta-carotene.
  • 2’-FL and/or propionic acid and/or butyric acid or derivative(s) thereof, and/or beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably 2’-FL, sodium prop
  • the nutritional supplement or the functional food is for use in the dietary management of gastro-intestinal dysfunction.
  • the nutritional supplement or the functional food is for use in the in the dietary management of a morbidity associated to gastro-intestinal dysfunction.
  • the nutritional supplement or the functional food is for use in the in the dietary management of an associated morbidity of the esophagus, in particular of a human subject having or being suspected of having or at risk of developing gastro-intestinal dysfunction.
  • the nutritional supplement or the functional food is for use in the in the dietary management of functional chest pain, functional heartburn, reflux hypersensitivity, globus, functional dysphagia, esophagitis, esophageal ulceration, esophageal cancer, in particular of a human subject having or being suspected of having or at risk of developing gastro-intestinal dysfunction.
  • the nutritional supplement or the functional food is for use in the in the dietary management of an associated morbidity of the stomach, in particular of a human subject having or being suspected of having or at risk of developing gastro-intestinal dysfunction.
  • the nutritional supplement or the functional food is for use in the in the dietary management of functional dyspepsia, belching disorders, nausea, vomiting, rumination syndrome, dyspepsia, malnutrition, pernicious anemia, gastritis, gastroenteritis, diarrhea, Crohn’s disease, gastric stenosis, gastric ulcers, gastric cancer, in particular of a human subject having or being suspected of having or at risk of developing gastro-intestinal dysfunction.
  • the nutritional supplement or the functional food is for use in the in the dietary management of an associated morbidity of small intestine, in particular of a human subject having or being suspected of having or at risk of developing gastro-intestinal dysfunction.
  • the nutritional supplement or the functional food is for use in the in the dietary management of maldigestion, malnutrition, enteritis, enterocolitis, necrotizing enterocolitis diarrhea, constipation, Coeliac disease, tropical sprue, inflammatory bowel disease (IBD) which includes Crohn’s disease, ulcerative colitis and other inflammatory diseases, vitamin deficiency, mineral deficiency, trace element deficiency, fatty acid deficiency, amino acid deficiency, intestinal ulcers, intestinal cancer, in particular of a human subject having or being suspected of having or at risk of developing gastro-intestinal dysfunction.
  • IBD inflammatory bowel disease
  • the nutritional supplement or the functional food is for use in the in the dietary management of an associated morbidity of the large intestine, in particular of a human subject having or being suspected of having or at risk of developing gastro intestinal dysfunction.
  • the nutritional supplement or the functional food is for use in the in the dietary management of diverticulitis, colitis, pseudomembranous colitis, diarrhea, constipation, irritable bowel syndrome (IBS), inflammatory bowel disease which includes Crohn’s disease, ulcerative colitis and other inflammatory diseases, colo-rectal ulcers, colo-rectal cancer, in particular of a human subject having or being suspected of having or at risk of developing gastro intestinal dysfunction.
  • kits for the pharmaceutical use or dietary management use comprising a first component comprising at least one HMO and a second component comprising at least one C3-C4-alkane carboxylic acid or derivative(s) thereof and optionally a third component comprising at least one carotenoid.
  • the present invention provides a kit for the pharmaceutical use or dietary management use comprising a first component comprising 2’-FL, and a second component comprising propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and optionally a third component comprising astaxanthin, alpha-carotene, beta-carotene, beta-cryptoxanthin, lycopene, lutein, meso-zeaxanthin and/or zeaxanthin, preferably beta-carotene and/or lutein, especially beta-carotene.
  • a kit for the pharmaceutical use or dietary management use comprising a first component comprising 2’-FL, and a second component comprising propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and optionally a third component comprising astaxanthin, alpha-carotene, beta-carotene, beta-cryptoxant
  • the present invention provides a kit for the pharmaceutical use or dietary management use comprising a first component comprising 2’-FL, a second component comprising propionic acid or derivative(s) thereof, preferably sodium propionate, and a third component comprising butyric acid or derivative(s) thereof, preferably sodium butyrate, and optionally a forth component comprising astaxanthin, alpha-carotene, beta-carotene, beta-cryptoxanthin, lycopene, lutein, meso-zeaxanthin and/or zeaxanthin, preferably beta-carotene and/or lutein, especially beta- carotene.
  • the present invention provides said kit for the pharmaceutical use for the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto or dietary management use for the dietary management of subjects having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto, in particular of subjects having gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides said kit for the pharmaceutical use or dietary management use for the treatment or prevention of gastro-intestinal dysfunction or dietary management use for the dietary management of subjects having, being suspected of having or being at risk of developing gastro-intestinal dysfunction in particular of subjects having gastro intestinal dysfunction.
  • the present invention provides said kit for the pharmaceutical use or dietary management use for the treatment or prevention of morbidities associated to gastro-intestinal dysfunction or dietary management use for the dietary management of subjects having, being suspected of having or being at risk of developing associated morbidities to gastro-intestinal dysfunction in particular of subjects having associated morbidities thereto.
  • kits for the pharmaceutical use comprising a first component comprising at least one HMO, and a second component comprising a pharmaceutical, preferably a pharmaceutical for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto , and optionally a third component comprising at least one C3- C4-alkane carboxylic acid or derivative(s) thereof.
  • the present invention provides a kit for the pharmaceutical use comprising a first component which is 2’-FL, a second component comprising an antibiotic (like cefaclor, cefuroxime, penicillin, amoxicillin and the like), an anti-inflammatory drug (like prednisone and the like), and/or an immunomodulator (like azathioprine, methotrexate, infliximab, adalimumab, certolizumab, vedolizumab, ustekinumab, natalizumab and the like) in a pharmaceutical effective amount, and optionally propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate.
  • an antibiotic like cefaclor, cefuroxime, penicillin, amoxicillin and the like
  • an anti-inflammatory drug like prednisone and the like
  • an immunomodulator like azathioprine, methotrexate, infliximab, ada
  • kits for the pharmaceutical use comprising a first component comprising at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and a second component comprising a pharmaceutical, preferably a pharmaceutical for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto , and optionally a third component comprising at least one HMO.
  • the present invention provides a kit for the pharmaceutical use comprising a first component which is propionic acid and/or butyric acid or derivative(s) thereof, a second component comprising an antibiotic (like cefaclor, cefuroxime, penicillin, amoxicillin and the like), an antiinflammatory drug (like prednisone and the like), and/or an immunomodulator (like azathioprine, methotrexate, infliximab, adalimumab, certolizumab, vedolizumab, ustekinumab, natalizumab and the like) in a pharmaceutical effective amount, and optionally a third component which is 2’-FL.
  • an antibiotic like cefaclor, cefuroxime, penicillin, amoxicillin and the like
  • an antiinflammatory drug like prednisone and the like
  • an immunomodulator like azathioprine, methotrexate, infliximab, adalimumab, certolizum
  • the present invention provides a kit for the pharmaceutical use comprising a first component comprising at least one carotenoid and a second component comprising a pharmaceutical, preferably a pharmaceutical for use in the treatment or prevention of gastrointestinal dysfunction and/or associated morbidities thereto , and optionally a third component comprising at least one HMO and/or at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • the present invention provides a kit for the pharmaceutical use comprising a first component which is beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, a second component comprising an antibiotic (like cefaclor, cefuroxime, penicillin, amoxicillin and the like), an anti-inflammatory drug (like prednisone and the like), and/or an immunomodulator (like azathioprine, methotrexate, infliximab, adalimumab, certolizumab, vedolizumab, ustekinumab, natalizumab and the like) in a pharmaceutical effective amount, and optionally a third component 2’-FL, and/or optionally a third component which is propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate.
  • the present invention provides a kit for the pharmaceutical use comprising a first component comprising at least one HMO and a second component comprising a pharmaceutical, preferably a pharmaceutical for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto , and a third component comprising at least one C3-C4-alkane carboxylic acid or derivative(s) thereof and a forth component comprising at least one carotenoid.
  • the present invention provides a kit for the pharmaceutical use comprising a first component which is 2’-FL, a second component comprising an antibiotic (like cefaclor, cefuroxime, penicillin, amoxicillin and the like), an anti-inflammatory drug (like prednisone and the like), and/or an immunomodulator (like azathioprine, methotrexate, infliximab, adalimumab, certolizumab, vedolizumab, ustekinumab, natalizumab and the like) in a pharmaceutical effective amount, a third component which is propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and a forth component which is beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta-carotene and/or lutein, especially beta-carotene.
  • an antibiotic like cefaclor,
  • butyric acid denotes n-butyric acid and the term “butyrate” denotes n-butyrate.
  • the term ”at least one HMO” is interchangeable with the term ’’component A
  • the term ”at least one C3-C4-alkane carboxylic acid or a derivative thereof’ is interchangeable with the term “component B”
  • the term “at least one carotenoid” is interchangeable with the term “component C”.
  • a composition comprises several components that these can also be administered separately. However, this means that such components can be administered together or separately, as the case may be.
  • compositions of the present invention can comprise, consist of, or consist essentially of the essential elements and limitations of the invention described herein, as well as any additional or optional ingredients, components, or limitations described herein or otherwise depending on the needs.
  • the terminology as set forth herein is for description of the embodiments only and should not be construed as limiting the disclosure as a whole. In a particular embodiment the compositions of the invention consist essentially of the essential elements, and even more particular consist of the essential elements.
  • a composition I comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or a derivative thereof, and optionally iii) at least one carotenoid.
  • composition I according to any one of embodiments 1-1 to 3-1, wherein one of the at least one HMO’s is a sialylated oligosaccharide.
  • composition I according to any one of embodiments 1-1 to 6-1, wherein one of the at least one HMO is lacto-N-tetraose (LNT).
  • LNT lacto-N-tetraose
  • composition I according to any one of embodiments 1-1 to 7-1, wherein the at least one
  • HMO is one or more HMOs selected from the group consisting of 2’-FL, 3-FL, difucosyllactose (in particular 2’,2”-DiFL and/or 3, 2’-DiFL), LNT, LNnT, 3’-SL and 6’-SL.
  • composition I according to any one of embodiments 1-1 to 8-1, wherein the at least one
  • HMO is one, two or three HMOs selected from the group consisting of 2’-FL, 3-FL, difucosyllactose (in particular 2’, 2”-DiFL and/or 3, 2’-DiFL), LNT, LNnT, 3’-SL and 6’-SL.
  • composition I according to any one of embodiments 1-1 to 9-1, wherein the at least one
  • HMO is one, two or three HMOs selected from the group consisting of 2’-FL, LNT, LNnT, 3’-SL and 6’-SL.
  • composition I according to any one of embodiments 1-1 to 9-1, wherein the at least one
  • HMO is one, two or three HMOs selected from the group consisting of 2’-FL, 2’,2”-DiFL and 3,2’-DiFL.
  • composition I according to any one of embodiments 1-1 to 11-1 wherein the at least one
  • HMO is 2’-FL.
  • composition I according to any one of embodiments 1-1 to 12-1, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is propionic acid or a derivative thereof.
  • composition I according to any one of embodiments 1-1 to 13-1, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is a physiologically acceptable salt or ester of propionic acid.
  • composition I according to any one of embodiments 1-1 to 16-1 wherein the at least one
  • C3-C4-alkane carboxylic acid or a derivative thereof is sodium or potassium propionate.
  • composition I according to any one of embodiments 1-1 to 14-1, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is a C1-C6 alkyl ester or a mono- or diglyceride of propionic acid.
  • composition I according to any one of embodiments 1-1 to 18-1, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is butyric acid or a derivative thereof.
  • composition I according to any one of embodiments 1-1 to 19-1, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is a physiologically acceptable salt or ester of butyric acid.
  • composition I according to any one of embodiments 1-1 to 20-1, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is an alkali salt or an alkaline earth salt of butyric acid.
  • composition I according to any one of embodiments 1-1 to 21-1, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is sodium or potassium salt of butyric acid.
  • composition I according to any one of embodiments 1-1 to 22-1 wherein the at least one
  • C3-C4-alkane carboxylic acid or a derivative thereof is a sodium or potassium butyrate.
  • composition I according to any one of embodiments 1-1 to 20-1, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is a C1-C6 alkyl ester or a mono- or diglyceride of butyric acid.
  • composition I according to any one of embodiments 1-1 to 24-1, wherein the at least one
  • C3-C4-alkane carboxylic acid or a derivative thereof is propionic acid or a derivative thereof and butyric acid or a derivative thereof.
  • 26-I The composition I according to any one of embodiments 1-1 to 25-1, wherein the at least one
  • C3-C4-alkane carboxylic acid or a derivative thereof is a physiologically acceptable salt of propionic acid and physiologically acceptable salt of butyric acid.
  • composition I according to any one of embodiments 1-1 to 26-1, wherein the at least one
  • C3-C4-alkane carboxylic acid or a derivative thereof is an alkali salt or an alkaline earth salt of propionic acid and an alkali salt or an alkaline earth salt of butyric acid.
  • composition I according to any one of embodiments 1-1 to 27-1, wherein the at least one
  • C3-C4-alkane carboxylic acid or a derivative thereof is a sodium or potassium salt of propionic acid and a sodium or potassium salt of butyric acid.
  • composition I according to any one of embodiments 1-1 to 28-1 wherein the at least one
  • C3-C4-alkane carboxylic acid or a derivative thereof is sodium or potassium propionate and sodium or potassium butyrate.
  • composition I according to any one of embodiments 1-1 to 25-1, wherein the at least one
  • C3-C4-alkane carboxylic acid or a derivative thereof is a physiologically acceptable ester of propionic acid and a physiologically acceptable ester of butyric acid.
  • composition I according to any one of embodiments 1-1 to 30-1, wherein the at least one
  • C3-C4-alkane carboxylic acid or a derivative thereof is a C1-C6 alkyl ester or a mono- or diglyceride of propionic acid and a C1 -C6 alkyl ester or a mono- or diglyceride of butyric acid.
  • composition I according to any one of embodiments 1-1 to 31-1 which does not comprise one or more carotenoids.
  • composition I according to any one of embodiments 1-1 to 31-1 which comprises at least one carotenoid.
  • composition I according to any one of embodiments 1-1 to 33-1, wherein one of the at least one carotenoid is selected from the group consisting of astaxanthin, alpha-carotene, beta- carotene, beta-cryptoxanthin, lutein, lycopene, meso-zeaxanthin, zeaxanthin (including cis/trans isomers) and/or mixtures thereof.
  • 36-I The composition I according to any one of embodiments 1-1 to 35-1, wherein one of the at least one carotenoid is beta-carotene.
  • composition I according to any one of embodiments 1-1 to 36-1, wherein one of the at least one carotenoid is lutein.
  • composition I according to any one of embodiments 1-1 to 37-1, wherein the weight to weight ratio of the at least one HMO (component A) : the at least one C3-C4 alkane carboxylic acid or a derivative thereof (component B) is from 100:1 to 1 :100.
  • composition I according to any one of embodiments 1-1 to 38-1, wherein the weight to weight ratio of (component A) : (component B) is from 20: 1 to 1 :20, preferably from 10:1 to 1 :10, more preferably from 3:1 to 1 :3, in particular from 2:1 to 1 :2.
  • composition I according to any one of embodiments 25-I to 39-I, wherein the weight to weight ratio of the propionic acid or a derivative thereof: butyric acid or a derivative thereof is from 100:1 to 1 : 100.
  • composition I according to any one of embodiments 25-1 to 40-1 , wherein the weight to weight ratio of the propionic acid or a derivative thereof : butyric acid or a derivative thereof is from 20:1 to 1 :20, preferably from 10:1 to 1 :15, more preferably from 2:1 to 1 :8.
  • composition I according to any one of embodiments 1-1 to 41-1, wherein the weight to weight ratio of (component A): (component C) is from 1 :1 to 200000:1.
  • composition I according to any one of embodiments 1-1 to 42-1, wherein the weight to weight ratio of (component B): (component C) is from 1 :1 to 200000:1 .
  • composition I according to any one of embodiments 1-1 to 43-1, wherein the at least one
  • HMO and the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof are present in synergistic amounts.
  • composition I according to any one of embodiments 1-1 to 44-1, wherein the at least one
  • HMO and the at least one carotenoid are present in synergistic amounts.
  • composition I according to any one of embodiments 1-1 to 45-1, wherein the at least one
  • HMO and the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof and the at least one carotenoid are present in synergistic amounts.
  • composition I according to any one of embodiments 1-1 to 47-1, wherein the total amount of the at least one HMO and the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof and optionally the at least one carotenoid is from 1 to 100 wt% of the total composition I, preferably from 10 to 100 wt%.
  • composition I according to any one of embodiments 1-1 to 48-1, wherein the total amount of the at least one HMO is from 10 to 90 wt% of the total composition I, preferably from 20 to 80 wt%, more preferably from 30 to 70 wt%, even more preferably from 40 to 60 wt%.
  • composition I according to any one of embodiments 1-1 to 48-1, wherein the total amount of the at least one HMO is from 5 to 50 wt% of the total composition I, preferably from 8 to 40 wt%, more preferably from 10 to 35 wt%, even more preferably from 15 to 30 wt%.
  • composition I according to any one of embodiments 1-1 to 49-1, wherein the total amount of the at least one HMO is from 50 to 95 wt% of the total composition I, preferably from 55 to 80 wt%, more preferably from 60 to 75 wt%.
  • composition I according to any one of embodiments 1-1 to 51-1, wherein the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 10 to 90 wt% of the total composition I, preferably from 15 to 85 wt%, more preferably from 20 to 75 wt%, even more preferably from 25 to 60 wt%.
  • composition I according to any one of embodiments 1-1 to 52-1, wherein the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 10 to 50 wt% of the total composition I, preferably from 15 to 45 wt%, more preferably from 20 to 35 wt%.
  • composition I according to any one of embodiments 1-1 to 52-1, wherein the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 50 to 90 wt% of the total composition I, preferably from 55 to 80 wt%, more preferably from 60 to 75 wt%.
  • 56-I The composition I according to any one of embodiments 1-1 to 55-1, wherein the composition I further comprises one or more vitamins or related compounds thereto.
  • composition I according to embodiment 56-1 wherein the one or more vitamins or related compounds thereto are selected from the group consisting of vitamin A, vitamin B1 , vitamin B2, vitamin B3, pantothenic acid, vitamin B6, biotin, folic acid, vitamin B12, vitamin E, vitamin K, vitamin C and vitamin D, or related compounds thereto and/or mixtures thereof.
  • composition I according to embodiment 57-I, wherein the one or more vitamins or related compounds thereto is a vitamin D compound.
  • composition I according to embodiment 58-I, wherein the vitamin D compound relates to calciferol, cholecalciferol, 1 ,25-dihydroxyvitamin D and/or ergocalciferol, preferably cholecalciferol and/or ergocalciferol, preferably cholecalciferol.
  • composition I according to any one of embodiments 1-1 to 59-1, wherein the composition I further comprises one or more medium-chain fatty acids, in free form, as glyceride, phospholipid, alkyl ester and/or mixtures thereof.
  • composition I according to embodiment 60-1 wherein the one or more medium chain fatty acids are selected from the group of caproic acid, caprylic acid, capric acid, lauric acid and/or mixtures.
  • composition I according to any one of embodiments 1-1 to 61-1, wherein the composition I further comprises one or more long-chain fatty acids, in free form, as glyceride, phospholipid, alkyl ester and/or mixtures thereof.
  • composition I according to embodiment 62-1 wherein the one or more long chain fatty acids are selected from the group of saturated long chain fatty acids, mono-unsaturated long chain fatty acids, polyunsaturated long chain fatty acids and/or mixtures thereof.
  • composition I according to any one of embodiments 1-1 to 63-1, wherein the composition I further comprises one or more prebiotics.
  • composition I according to embodiment 64-1 wherein the one or more prebiotics are selected from the group of water-insoluble fibers, water-soluble fibers and/or mixtures thereof.
  • composition I according to any one of embodiments 1-1 to 65-1, wherein the composition I further comprises one or more probiotics.
  • 67-I The composition I according to embodiment 66-I, wherein the one or more probiotics are selected from the group of the family Lactobacilaceae, preferably of the genus Lactobacillus, in particular of the species lactobacillus acidophilus, lactobacillus alimentarius, lactobacillus casei, lactobacillus delbrueckii, lactobacillus helveticus, lactobacillus plantarum, lactobacillus reuteri, lactobacillus rhamnosus, lactobacillus salivarius, of the genus Bifidobacterium, in particular of the species bifidobacterium animalis, bifidobacterium bifidum, bifidobacterium breve, bifidobacterium infantis, bifidobacter
  • composition I according to any one of embodiments 1-1 to 67-1, wherein the composition I further comprises one or more phenolic compounds.
  • composition I according to embodiment 68-1 wherein the one or more phenolic compounds are selected from the group of monophenols, flavonoids, isoflavonoids, aurones, chalconoids, flavonolignans, lignans, phytoestrogens, stilbenoids, piceatannol, curcuminoids, tannins, aromatic acids, phenylethanoids, capsaicin, gingerol, alkylresorcinol and/or mixtures thereof.
  • composition I according to any one of embodiments 1-1 to 69-1, wherein the composition I further comprises one or more herbals.
  • composition I according to embodiment 70-1 wherein the one or more herbals are selected from herbals known from Chinese diets, Indian diets, Mediterranean diets and/or mixtures thereof.
  • composition I according to any one of embodiments 1-1 to 71-1, wherein the composition I further comprises one or more minerals.
  • composition I according to any one of embodiments 1-1 to 72-1, wherein the composition does not comprise an antibody.
  • composition I according to embodiment 75-1, wherein the gastro-intestinal dysfunction and/or associated morbidities thereto is an abnormal function of the gastro-intestinal system, in particular of a human.
  • composition I according to embodiment 76-1 wherein the gastro-intestinal dysfunction is a disturbance of digestion and absorption processes; disturbance of motility; disturbance of barrier function and immune system; disturbance of formation and deposition of feces in particular of a human.
  • composition I as described in any one of embodiments 1-1 to 79-1, wherein the associated morbidity is functional dyspepsia, belching disorders, nausea, vomiting, rumination syndrome, dyspepsia, malnutrition, pernicious anemia, gastritis, gastroenteritis, diarrhea, Crohn’s disease, gastric stenosis, gastric ulcers, gastric cancer of a subject, in particular a human, even more particular a human having gastro-intestinal dysfunction.
  • the associated morbidity is functional dyspepsia, belching disorders, nausea, vomiting, rumination syndrome, dyspepsia, malnutrition, pernicious anemia, gastritis, gastroenteritis, diarrhea, Crohn’s disease, gastric stenosis, gastric ulcers, gastric cancer of a subject, in particular a human, even more particular a human having gastro-intestinal dysfunction.
  • composition I as described in any one of embodiments 1-1 to 79-1, wherein the associated morbidity is maldigestion, malnutrition, enteritis, enterocolitis, necrotizing enterocolitis diarrhea, constipation, Coeliac disease, tropical sprue, inflammatory bowel disease (IBD) which includes Crohn’s disease, ulcerative colitis and other inflammatory diseases, vitamin deficiency, mineral deficiency, trace element deficiency, fatty acid deficiency, amino acid deficiency, intestinal ulcers, intestinal cancer of a subject, in particular a human, even more particular a human having gastro-intestinal dysfunction.
  • IBD inflammatory bowel disease
  • composition I as described in any one of embodiments 1-1 to 79-1, wherein the associated morbidity is diverticulitis, colitis, pseudomembranous colitis, diarrhea, constipation, irritable bowel syndrome (IBS), inflammatory bowel disease which includes Crohn’s disease, ulcerative colitis and other inflammatory diseases, colo-rectal ulcers, colo-rectal cancer of a subject, in particular a human, even more particular a human having gastro-intestinal dysfunction.
  • IBS irritable bowel syndrome
  • composition I according to any one of embodiments 74-1 to 83-1, wherein the composition
  • I is an orally administrable composition.
  • a method for treating a subject having, suspected of having or being at risk of developing a disease, in particular gastro-intestinal dysfunction and/or associated morbidities thereto comprising administering to the subject an effective amount of a composition I according to any one of embodiments 1-1 to 73-1.
  • C3-C4-alkane carboxylic acid or derivative(s) thereof is propionic acid or a derivative thereof and is applied at a rate from 0.1 to 6.0 g/day, preferably from 0.5 to 5.0 g/day, more preferably from 1.0 to 4.0 g/day. 91-1.
  • C3-C4-alkane carboxylic acid or derivative(s) thereof is butyric acid and/or a derivative thereof and is applied at a rate from 0.1 to 9.0 g/day, preferably from 0.5 to 7.0 g/day, more preferably from 1.0 to 5.0 g/day..
  • C4-alkane carboxylic acid or derivative(s) thereof is a mixture of propionic acid or a derivative thereof and butyric acid or a derivative thereof and the application rate of propionic acid and/or a derivative thereof is from 0.1 to 4.0 g/day and the application rate of butyric acid and/or a derivative thereof is from 0.1 to 6.0 g/day, preferably the application rate of propionic acid and/or a derivative thereof is from 0.5 to 4.0 g/day, and the application rate of butyric acid and/or a derivative thereof is from 0.5 to 5.0 g/day, more preferably the application rate of propionic acid and/or a derivative thereof is from 1 .0 to 3.0 g/day, and the application rate of butyric acid and/or a derivative thereof is from 1.5 to 4.0 g/day.
  • composition I is administered orally.
  • a nutritional supplement or a functional food comprising a composition I according to any one of embodiments 1-1 to 73-1.
  • the nutritional supplement or the functional food according to embodiment 95-1 for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto, preferably of mammals, birds, crustaceans and/or fishes, more preferably of mammals, even more preferably of humans.
  • the nutritional supplement or functional food according to embodiment 96-1 for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro-intestinal dysfunction, preferably of mammals, birds, crustaceans and/or fishes, more preferably of mammals, even more preferably of humans.
  • the nutritional supplement or functional food according to embodiment 96-1 for use in the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to gastro-intestinal dysfunction, preferably of mammals, birds, crustaceans and/or fishes, more preferably of mammals, even more preferably of humans.
  • the nutritional supplement or functional food according to embodiment 98-I for use in the dietary management of subjects having, being suspected of having or being at risk of developing an associated morbidity of the esophagus, an associated morbidity of the stomach, an associated morbidity of the small intestine or an associated morbidity of the large intestine, in particular of a human, even more particular of a human having gastro-intestinal dysfunction.
  • the nutritional supplement or functional food according to embodiment 99-1 for use in the dietary management of subjects having, being suspected of having or being at risk of developing functional chest pain, functional heartburn, reflux hypersensitivity, globus, functional dysphagia, esophagitis, esophageal ulceration, esophageal cancer, in particular of a human, even more particular of a human having gastro-intestinal dysfunction.
  • the nutritional supplement or functional food according to embodiment 99-1 for use in the dietary management of subjects having, being suspected of having or being at risk of developing functional dyspepsia, belching disorders, nausea, vomiting, rumination syndrome, dyspepsia, malnutrition, pernicious anemia, gastritis, gastroenteritis, diarrhea, Crohn’s disease, gastric stenosis, gastric ulcers, gastric cancer, in particular of a human, even more particular of a human having gastro-intestinal dysfunction.
  • the nutritional supplement or functional food according to embodiment 99-1 for use in the dietary management of subjects having, being suspected of having or being at risk of developing maldigestion, malnutrition, enteritis, enterocolitis, necrotizing enterocolitis diarrhea, constipation, Coeliac disease, tropical sprue, inflammatory bowel disease (IBD) which includes Crohn’s disease, ulcerative colitis and other inflammatory diseases, vitamin deficiency, mineral deficiency, trace element deficiency, fatty acid deficiency, amino acid deficiency, intestinal ulcers, intestinal cancer, in particular of a human, even more particular of a human having gastro-intestinal dysfunction.
  • IBD inflammatory bowel disease
  • the nutritional supplement or functional food according to embodiment 99-1 for use in the dietary management of subjects having, being suspected of having or being at risk of developing diverticulitis, colitis, pseudomembranous colitis, diarrhea, constipation, irritable bowel syndrome (IBS), inflammatory bowel disease which includes Crohn’s disease, ulcerative colitis and other inflammatory diseases, colo-rectal ulcers, colo-rectal cancer, in particular of a human, even more particular of a human having gastro-intestinal dysfunction.
  • IBS irritable bowel syndrome
  • a method for the dietary management of a subject having, suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto comprising administering to the subject an effective amount of a composition I according to any one of embodiments 1-1 to 73-1 or a nutritional supplement according to any one of embodiments 95-1 to 103-1 or a functional food according to any one of embodiments 95-1 to 103-1.
  • the method according to any one of embodiments 104-1 to 107-1, wherein the application rate of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 0.1 to 10.0 g/day, preferably from 1.0 to 9.0 g/day, more preferably from 1.2 to 9.0 g/day, in particular from 2.0 to 8.0 g/day, especially from 2.5 to 6.0 g/day.
  • C4-alkane carboxylic acid or derivative(s) thereof is a mixture of propionic acid or a derivative thereof and butyric acid or a derivative thereof and the application rate of propionic acid and/or a derivative thereof is from 0.1 to 4.0 g/day and the application rate of butyric acid and/or a derivative thereof is from 0.1 to 6.0 g/day, preferably the application rate of propionic acid and/or a derivative thereof is from 0.5 to 4.0 g/day, and the application rate of butyric acid and/or a derivative thereof is from 0.5 to 5.0 g/day, more preferably the application rate of propionic acid and/or a derivative thereof is from 1.0 to 3.0 g/day, and the application rate of butyric acid and/or a derivative thereof is from 1.5 to 4.0 g/day.
  • 116-1 A composition I for use in the treatment or prevention of gastro-intestinal dysfunction according to any one of embodiments 75-1 to 84-1, a nutritional supplement or a functional food according to any one of embodiments 95-1 to 103-1, which is administered to a subject having or being suspected of having
  • a method to treat a subject having gastro-intestinal dysfunction and/or associated morbidities thereto by administering to the subject a) an effective amount of a composition I according to any one of embodiments 1-1 to 73-1, a composition I for use as a medicament according to embodiment 74-1, a composition I for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto according to any one of embodiments 75-1 to 84-1, a nutritional supplement or a functional food according to any one of embodiments 95-1 to 104-1, or with one of components A, B and C, or with two of components A, B and C as described in any one of embodiments 1-1 to 73-1, and b) an effective amount of at least one pharmaceutical suitable to treat said gastro-intestinal dysfunction and/or associated morbidities thereto, wherein the application rate of the at least one pharmaceutical suitable to treat said gastrointestinal dysfunction and/or associated morbidities thereto is reduced compared to a treatment with the at least one pharmaceutical alone.
  • gastro-intestinal dysfunction and/or associated morbidities thereto is gastro-intestinal dysfunction and wherein the at least one pharmaceutical suitable to treat said gastro-intestinal dysfunction, is selected from the group of pharmaceuticals to treat infections (antibiotics), inflammation (prednisone) or immunomodulators (azathioprine, methotrexate, infliximab, adalimumab, certolizumab, vedolizumab, ustekinumab, natalizumab).
  • infections antibiotics
  • inflammation prednisone
  • immunomodulators azathioprine, methotrexate, infliximab, adalimumab, certolizumab, vedolizumab, ustekinumab, natalizumab.
  • a composition comprising a) i) at least one HMO, and/or ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and/or iii) at least one carotenoid; and b) an effective amount of at least one pharmaceutical, especially being suitable for the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto, in particular for use as a medicament, especially for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto. -1.
  • a composition comprising a) i) as component A 2’-FL, and/or ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and/or sodium butyrate, and/or iii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta-carotene and/or lutein, especially beta-carotene; and b) an antibiotic (like cefaclor, cefuroxime, penicillin, amoxicillin and the like), an antiinflammatory drug (like prednisone and the like), and/or an immunomodulator (like azathioprine, methotrexate, infliximab, adalimumab, certolizumab, vedolizumab, ustekinumab, natalizumab and the like) in a pharmaceutical effective amount, in particular for use as a medicament, especially
  • composition I as defined in any one of embodiments 1-1 to 73-1 as a nutritional supplement for the dietary management of gastro-intestinal dysfunction and/or associated morbidities thereto.
  • kits forthe pharmaceutical use or dietary management use comprising a first component A being at least one HMO, preferably as described in any one of embodiments 1-1 to 73-1, and a second component B being at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, preferably as described in any of embodiments 1-1 to 73-1, and optionally a third component C being at least one carotenoid as described in any embodiments 1-1 to 73-1, for the treatment or prevention or dietary management use of gastro-intestinal dysfunction and/or associated morbidities thereto.
  • kits according to embodiment 120-1 wherein the kit is forthe pharmaceutical use forthe treatment or prevention of gastro-intestinal dysfunction or dietary management use of gastrointestinal dysfunction.
  • kits according to embodiment 120-1 wherein the kit is forthe pharmaceutical use forthe treatment or prevention of morbidities associated to gastro-intestinal dysfunction or dietary management use of morbidities associated to gastro-intestinal dysfunction.
  • a kit for the pharmaceutical use or dietary management use comprising a) a first component A being at least one HMO, preferably as described in any one of embodiments 1-1 to 73-1, and/or a second component B being at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, preferably as described in any of embodiments 1-1 to 73-1 , and/or a third component C being at least one carotenoid as described in any embodiments 1-1 to 73-1; and b) an effective amount of at least one pharmaceutical, especially being suitable for the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto, for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto.
  • kits forthe pharmaceutical use or dietary management use according to embodiment 127-1, wherein the at least one pharmaceutical is an antibiotic (like cefaclor, cefuroxime, penicillin, amoxicillin and the like), an anti-inflammatory drug (like prednisone and the like), and/or an immunomodulator (like azathioprine, methotrexate, infliximab, adalimumab, certolizumab, vedolizumab, ustekinumab, natalizumab and the like) in a pharmaceutical effective amount.
  • an antibiotic like cefaclor, cefuroxime, penicillin, amoxicillin and the like
  • an anti-inflammatory drug like prednisone and the like
  • an immunomodulator like azathioprine, methotrexate, infliximab, adalimumab, certolizumab, vedolizumab, ustekinumab, natalizumab and the like
  • composition II comprises i) at least one HMO, and ii) at least one carotenoid, and optionally iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • HMO refers to human milk oligosaccharide(s). These carbohydrates are resistant to enzymatic hydrolysis by digestive enzymes (e.g. pancreatic and/or brush border).
  • digestive enzymes e.g. pancreatic and/or brush border.
  • HMOs are found in the human breast milk. Each individual HMO is based on a combination of glucose, galactose, sialic acid (N-acetylneuraminic acid), fucose and/or N-acetylglucosamine with many and varied linkages between them. So far over 130 such structures have been identified in human milk.
  • the HMOs can be acidic (e.g. charged sialic acid containing oligosaccharide) or neutral (e.g. fucosylated oligosaccharide).
  • the HMO is selected from the group of fucosylated oligosaccharides, N-acetylated oligosaccharides and sialylated oligosaccharides.
  • the HMO is a "fucosylated oligosaccharide". These are HMOs having a fucose residue. It has a neutral nature. Some examples are 2'-FL (2'-fucosyllactose), 3-FL (3-fucosyllactose), difucosyllactose, lacto-N-fucopentaose (e.g.
  • lacto-N- fucopentaose I lacto- N-fucopentaose II, lacto-N-fucopentaose III, lacto-N-fucopentaose V)
  • lacto-N-fucohexaose lacto-N- difucohexaose I, fucosyllacto-N-hexaose, fucosyllacto- N-neohexaose, difucosyllacto-N-hexaose I, difucosyllacto-N-neohexaose II and any combination thereof.
  • the fucosylated oligosaccharide is selected from the group comprising 2’-FL, 3-FL and difucosyllactose (e.g. 2’,2”-DiFL and/or 3, 2’-DiFL).
  • the fucosylated oligosaccharide is 2’-FL.
  • the HMO is a ”N-acetylated oligosaccharide.
  • the term ”N-acetylated oligosaccharide(s)” encompasses both "N-acetyl-lactosamine” and "oligosaccharide(s) containing N-acetyl-lactosamine". They are neutral oligosaccharides having an N-acetyl-lactosamine residue. Suitable examples are LNT (lacto-N-tetraose), para-lacto-N- neohexaose (para-LNnH), LNnT (lacto-N-neotetraose) or any combination thereof.
  • N-acetylated oligosaccharide is selected from the group of LNT and LNnT.
  • the HMO is a ’’sialylated oligosaccharide.
  • the term ’’sialylated oligosaccharide encompasses an oligosaccharide having a sialic acid residue. It has an acidic nature. Some examples are 3’-SL (3'-sialyllactose) and 6’-SL (6'-sialyllactose). In a preferred embodiment the sialylated oligosaccharide is 6’-SL.
  • the HMO is selected from the group comprising 2’-FL, 3-FL, difucosyllactose (e.g. 2’,2”-DiFL and/or 3, 2’-DiFL), LNT, LNnT, 3’-SL and 6’-SL and/or any combination thereof.
  • the HMO is selected from the group comprising 2’-FL, difucosyllactose (e.g. 2’,2”-DiFL and/or 3,2’-DiFL), LNT, LNnT and 6’-SL and/or any combination thereof.
  • the HMO is selected from the group comprising 2’-FL, LNT, LNnT and 6'-SL and/or any combination thereof.
  • C3-C4-alkane carboxylic acid or derivative thereof encompasses propionic acid, n-butyric acid and iso-butyric acid (2-methyl propionic acid) as well as derivatives thereof and/or any mixture thereof.
  • Suitable derivatives are salts, esters and amides, in particular physiologically acceptable ones.
  • physiologically acceptable salts are alkali salts, like sodium or potassium salts, or alkaline-earth salts, like magnesium or calcium salts, or choline salts.
  • physiologically acceptable salts are alkali salts, in particular sodium salts or potassium salts, especially sodium salts.
  • physiologically acceptable esters are those derived from C1-C6 alcohols, in particular those derived from monohydric C1-C6 alcohols, e.g. those derived from methanol or ethanol, or dihydric C1-C6 alcohols, like those derived from 1 ,2-ethandiol, or C1-C4 alkoxy substituted monohydric alcohols, like those derived from 2-methoxyethanol, 2-ethoxyethanol or 2-butoxyethanol.
  • Other examples for physiologically acceptable esters are glycerides, like mono-, di-, or triglycerides, in particular mono- or diglycerides.
  • the physiologically acceptable esters are those derived from monohydric C1-C6 alcohols, e.g. those derived from methanol or ethanol, or mono- or diglycerides.
  • physiologically acceptable amides are those derived from mono- or di-C1-C6-alkyl amines.
  • the C3-C4 alkane carboxylic acid is provided as physiologically acceptable derivative thereof; in particular the derivative is a physiologically acceptable salt, e.g. a sodium salt or potassium salt, or a mixture thereof, or a physiologically acceptable ester, e.g. said ester is derived from C1-C6 alcohols, in particular a mono-or a dihydric C1-C6 alcohol, or said ester is a mono- or diglyceride, or a mixture thereof.
  • the C3-C4-alkane carboxylic acid or derivative thereof is sodium propionate or potassium propionate or sodium butyrate or potassium butyrate or a mixture thereof. Especially, it is sodium propionate or sodium butyrate or a mixture thereof.
  • the C3-C4-alkane carboxylic acid or derivative thereof is propionic acid or a derivative thereof, in particular it is a physiologically acceptable salt of propionic acid, especially it is sodium propionate or potassium propionate, or a physiologically acceptable ester of propionic acid, especially methyl propionate or ethyl propionate or propionic acid monoglyceride or propionic acid diglyceride, particularly ethyl propionate or propionic acid monoglyceride.
  • the C3-C4-alkane carboxylic acid or derivative thereof is sodium propionate or potassium propionate.
  • the C3-C4-alkane carboxylic acid or derivative thereof is butyric acid or a derivative thereof, in particular it is a physiologically acceptable salt of butyric acid, especially it is sodium butyrate or potassium butyrate, or a physiologically acceptable ester of butyric acid, especially methyl butyrate or ethyl butyrate or butyric acid monoglyceride or butyric acid diglyceride, particularly ethyl butyrate or butyric acid monoglyceride.
  • the C3-C4- alkane carboxylic acid or derivative thereof is sodium butyrate or potassium butyrate.
  • the at least one C3-C4-alkane carboxylic acid or derivative thereof is a mixture of propionic acid and butyric acid or derivatives thereof, in particular it is a mixture of physiologically acceptable salts of propionic acid and butyric acid, especially it is a mixture of sodium propionate and sodium butyrate or a mixture of potassium propionate and potassium butyrate, or a mixture of physiologically acceptable esters of propionic acid and butyric acid, especially a mixture of methyl propionate and methyl butyrate, or a mixture of ethyl propionate and ethyl butyrate, or a mixture of propionic acid monoglyceride and butyric acid monoglyceride, or a mixture of propionic acid diglyceride and butyric acid diglyceride, particularly a mixture of ethyl propionate and ethyl butyrate or a mixture of propionic acid monoglyceride and butyric acid monoglyceride.
  • the term “carotenoid” relates to at least one carotenoid selected from the group consisting of astaxanthin, alpha-carotene, beta-carotene, beta-cryptoxanthin, lycopene, lutein, meso-zeaxanthin and zeaxanthin.
  • the carotenoid is at least one selected from the group consisting of beta-carotene, lycopene, lutein and meso-zeaxanthin or mixtures thereof, particularly it is beta-carotene and/or lutein, especially it is beta-carotene.
  • composition II comprises i) at least one HMO, and ii) at least one carotenoid.
  • composition II comprises i) as component A 2’-FL, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene.
  • composition II does not comprise one or more C3-C4- alkane carboxylic acid or derivative(s) thereof.
  • composition II comprises i) at least one HMO, and ii) at least one carotenoid, and iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • the composition II comprises i) as component A 2’-FL, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, and iii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate.
  • the composition II comprises i) at least one HMO, and ii) at least one carotenoid, and optionally iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, wherein the ratio of the at least one HMO (component A) and the at least one carotenoid (component C) is from 1 : 1 to 200000: 1.
  • the at least one HMO and the at least one carotenoid are present in synergistic amounts.
  • composition II does not comprise one or more C3- C4-alkane carboxylic acid or derivative(s) thereof.
  • the composition II comprises i) at least one HMO, and ii) at least one carotenoid, and iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, wherein the ratio of the at least one HMO (component A) and the at least one carotenoid (component C) is from 1 : 1 to 200000:1 , and/or wherein the ratio of the at least one HMO (component A) and the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof (component B) is from 100 :1 to 1 : 100, preferably from 20:1 to 1 :20, more preferably 10:1 to 1 :10, even more preferably from 3: 1 to 1 :3, in particular2:1 to 1 :2, and/or wherein the ratio of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof (component B) and the at least one carotenoid
  • said composition II comprises as at least one C3- C4-alkane carboxylic acid or derivative(s) thereof a mixture of propionic acid or a derivative thereof and butyric acid or a derivative thereof, in a ratio of from 100 : 1 to 1 : 100, preferably from 20:1 to 1 : 20, more preferably from 10:1 to 1 :15, even more preferably from 2:1 to 1 :8.
  • the at least one HMO and the at least one the carotenoid are present in synergistic amounts.
  • the at least one HMO and the at least one C3-C4- alkane carboxylic acid or derivative(s) thereof are present in synergistic amounts.
  • the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof and the at least one carotenoid are present in synergistic amounts.
  • the at least one HMO, the at least one carotenoid and the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof are present in synergistic amounts.
  • the total amount of the at least one HMO and the at least one carotenoid, and optionally the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 1 to 100 wt% of the total composition II, preferably from 10 to 100 wt%.
  • the total amount of the at least one HMO is from 10 to 99.99999 wt% of the total composition II, preferably from 20 to 99.9999 wt%, more preferably from 30 to 99.999 wt%, even more preferably from 40 to 99.9 wt%. In yet another embodiment the total amount of the at least one HMO is from 5 to 50 wt% of the total composition II, preferably from 8 to 40 wt%, more preferably from 10 to 35 wt%, even more preferably from 15 to 30 wt%. In yet another embodiment the total amount of the at least one HMO is from 50 to 95 wt% of the total composition II, preferably from 55 to 80 wt%, more preferably from 60 to 75 wt%.
  • the total amount of the at least one carotenoid is from 0.0005 to 50 wt% of the total composition I, preferably from 0.005 to 5.0 wt%, more preferably from 0.05 to 0.5 wt%, even more preferably from 0.5 to 4 wt%, even more preferably from 0.1 to 4 wt%, even more preferably from 0.1 to 3 wt%, even more preferably from 0.1 to 2 wt%, even more preferably from 0.1 to 1 wt%.
  • the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 10 to 90 wt% of the total composition II, preferably from 15 to 85 wt%, more preferably from 20 to 75 wt%, even more preferably from 25 to 60 wt%. In yet another embodiment the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 10 to 50 wt% of the total composition II, preferably from 15 to 45 wt%, more preferably from 20 to 35 wt%.
  • the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 50 to 90 wt% of the total composition II, preferably from 55 to 80 wt%, more preferably from 60 to 75 wt%.
  • the composition II can further comprise one or more vitamins or related compounds thereto.
  • vitamins and related compounds thereto include vitamin A (e.g. retinol, retinyl acetate, retinyl palmitate, retinyl stearate, retinyl esters with other long-chain unsaturated fatty acids, retinal, retinoic acid and the like), vitamin B1 (e.g. thiamine, thiamine pyrophosphate, TPP, thiamine triphosphate, TTP, thiamine hydrochloride, thiamine mononitrate and the like), vitamin B2 (e.g.
  • vitamin B3 e.g. nicotinic acid, nicotinamide, nicotinamide adenine dinucleotide (NAD), nicotinic acid mononucleotide (NicMN), pyridine-3-carboxylic acid and the like, as well as the vitamin B3-precursor tryptophan
  • pantothenic acid e.g. pantothenate, panthenol and the like
  • vitamin B6 e.g.
  • pyridoxine pyridoxal, pyridoxamine, pyridoxine hydrochloride and the like
  • biotin folic acid (e.g. folate, folacin, pteroylglutamic acid and the like)
  • vitamin B12 e.g. cobalamin, methylcobalamin. deoxyadenosyl- cobalamin, cyanocobalamin, hydroxycobalamin, adenosylcobalamin and the like
  • vitamin E e.g.
  • alpha-, beta-, gamma- and/or delta-tocopherol alpha-, beta-, gamma- and/or delta-tocopherol acetate, alpha-, beta-, gamma- and/or delta-tocopherol succinate, alpha-, beta-, gamma- and/or delta-tocopherol nicotinate, alpha-, beta-, gamma- and/or delta tocotrienol and the like
  • vitamin K e.g. vitamin K2, vitamin K1 , phylloquinone, naphthoquinone, vitamin K3, menadione, and the like
  • vitamin C ascorbic acid
  • vitamin D e.g.
  • calciferol cholecalciferol, 1 ,25-dihydroxyvitamin D, ergocalciferol and the like
  • the presence and amounts of specific vitamins and/or related compounds thereto will vary depending on the intended use.
  • composition II does not comprise one or C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • composition II does comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • composition II does not comprise one or more vitamins or related compounds thereto.
  • composition II does comprise one or more vitamins or related compounds thereto.
  • the composition II can further comprise one or more medium-chain fatty acids.
  • These medium-chain fatty acids may be provided as free fatty acids, as glycerides (e.g. as monoglycerides, diglycerides or triglycerides and/or as mixtures thereof), as phospholipids, as alkyl esters and/or as mixtures thereof, preferably as glycerides, more preferably as triglycerides or alkyl esters.
  • Examples of medium-chain fatty acids include caproic acid, caprylic acid, capric acid, lauric acid and the like and /or mixtures thereof.
  • composition II does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • composition II does comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • composition II does not comprise one or more medium-chain fatty acids.
  • composition II can further comprise one or more long-chain fatty acids.
  • long-chain fatty acids may be provided as free fatty acids, as glycerides (e.g. as monoglycerides, diglycerides or triglycerides and/or as mixtures thereof), as phospholipids, as alkyl esters and/or as mixtures thereof, preferably as glycerides, more preferably as triglycerides or as alkyl esters.
  • long chain fatty acids include saturated long chain fatty acids (e.g.
  • linoleic acid linoelaidic acid, alpha-linolenic acid, arachidonic acid, eicosapentaenoic acid, docosapentenoic acid, docosahexaenoic acid and the like and/or mixtures thereof) and/or mixtures thereof.
  • These long chain fatty acids are comprised for example in vegetable oils, single cell oils and marine oils, e.g. fish oil, krill oil and the like.
  • composition II does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • composition II does comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • composition II does not comprise one or more long-chain fatty acids.
  • composition II can further comprise one or more prebiotics.
  • prebiotics include water-insoluble fibers (e.g. lignin, cellulose, hemi- cellulose, resistant starch, xanthum gum and the like and/or mixtures thereof), water-soluble fibers (e.g.
  • arabinoxylan arabinoxylan, inulin, pectin, alginic acid and derivatives thereof, agar, carrageen, raffinose, xylose, polydextrose, lactulose, xylooligosaccharides, fructooligosaccharides, galactooligosaccharides, isomalto-oligosaccharides and the like and/or mixtures thereof) and the like and/or mixtures thereof.
  • composition II does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • composition II does comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • composition II does not comprise one or more prebiotics.
  • composition II can further comprise one or more probiotics.
  • probiotics optionally present in the composition II of the present invention include microorganisms or parts thereof of the family Lactobacillaceae, e.g. of the genus Lactobacillus (e.g. the species lactobacillus acidophilus, lactobacillus alimentarius, lactobacillus casei, lactobacillus delbrueckii (like lactobacillus delbrueckii spp. bulgaricus, lactobacillus delbrueckii spp.
  • Bifidobacterium e.g. the species bifidobacterium animalis, bifidobacterium bifidum, bifidobacterium breve, bifidobacterium infantis, bifidobacterium lactis, bifidobacterium longum and the like
  • Pediococcus e.g. the species bifidobacterium animalis, bifidobacterium bifidum, bifidobacterium breve, bifidobacterium infantis, bifidobacterium lactis, bifidobacterium longum and the like
  • Pediococcus e.g.
  • Lactococcus e.g. the species lactococcus lactis (like lactococcus latis spp. cremoris, lactococcus lactis spp. lactic and the like
  • composition II does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • composition II does comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • composition II does not comprise one or more probiotics.
  • composition II can further comprise one or more phenolic compounds.
  • phenolic compounds include monophenols (e.g. apiole, carnosol, carvacrol, dillapiole, rosemarinol and the like), flavonoids (e.g.
  • quercetin kaempferol, myricetin, fisetin, rutin, isorhamnetin, hesperidin, naringenin, silybin, eriodyctiol, acacetin, apigenin, chrysin, diosmetin, tangeritin, luteolin, catechins like epigallocatechin gallate, theaflavin, thearubigins, proanthocyanidins, pelargonidin, peonidin, cyanidin, delphinidin, malvidin, petunidin and the like), isoflavonoids (e.g.
  • daidzein genistein, glycitein and the like
  • aurones chalconoids
  • flavonolignans flavonolignans
  • lignans phytoestrogens
  • stilbenoids e.g. resveratrol, pterostilbene, piceatannol and the like
  • curcuminoids e.g. curcumin and the like
  • tannins aromatic acids (e.g. salicylic acid, vanillic acid, gallic acid, ellagic acid, tannic acid, caffeic acid, chlorogenic acid, cinnamic acid, ferulic acid, coumarin and the like), phenylethanoids (e.g.
  • tyrosol hydroxytyrosol, oleocanthal, oleuropein and the like
  • capsaicin gingerol
  • alkylresorcinol alkylresorcinol
  • composition II does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • composition II does comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • composition II does not comprise one or more phenolic compounds.
  • composition II can further comprise one or more herbals, e.g. known from Chinese diets, Indian diets, Mediterranean diets and the like. These herbals can be provided as powders obtained from the plant and/or fungus or parts thereof or as extracts thereof.
  • herbals e.g. known from Chinese diets, Indian diets, Mediterranean diets and the like. These herbals can be provided as powders obtained from the plant and/or fungus or parts thereof or as extracts thereof.
  • herbals known from Chinese diets include extracts or powders of hawthorn fruit, wolfberry, spatholobus stem, caterpillar fungus, cloud mushroom, crysanthemum, honeysuckle flower, mulberry leaf, glossy privet fruit, malaytea scurfpea fruit, cherokee rose fruit, palmleaf raspberry fruit, Chinese magnoliavine fruit, reishi mushroom, ephedra, epimedium, Angelica root, Astragalus root, rhubarb, licorice, morinda root, notoginseng, white peony root, American ginseng, fleeceflower root, kudzu root, rehmannia root, salvia root, Chinese yam, wild buckwheat rhizome, tall gastrodia tuber, golden root, Cassia seed, Coix seed, Dodder seed and the like and/or mixtures thereof.
  • herbals known from Indian diets include extracts or powders of Amalaki (Indian gooseberry), Haritaki (chebulic myrobalan), Bibhitaki (beleric), Haldi (turmeric), Tulsi (holy basil), Shigru (moringa), Twak (cinnamon), Yashtimadhu (licorice root), Dhanyaka (coriander), Ashwagandha (winter cherry), Kumkuma (saffron), Manjistha (Indian madder), Brahmi (bacopa), Neem (margosa), Ajwain (Bishop’s weed), Elaichi (cardamom), Shikakai (Acacia concinna), Shatavari (wild asparagus), Jeera (cumin), Guduchi (tinospora) and the like and/or mixtures thereof.
  • Examples for herbals known from Mediterranean diets include extracts or powders of rosemary, basil, parsley, saffron, thyme, oregano, sage, cilantro, lemon, orange, grape, grapeseed, fig, blueberry, raspberry, strawberry, cherry, fennel, sesame seeds, pine seeds, garlic, onion, ginger root, pepper, chili and the like, olive oil and/or mixtures thereof.
  • composition II does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • composition II does comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • composition II does not comprise one or more herbals.
  • composition II can further comprise one or more minerals.
  • minerals include such ones comprising calcium, phosphorous, iodine, iron, magnesium, copper, zinc, manganese, chlorine, potassium, sodium, selenium, chromium, molybdenum and the like and/or mixtures thereof. Minerals are usually added in salt form.
  • composition II does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • composition II does comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • composition II does not comprise one or more minerals. In a further embodiment of the present invention the composition II does not comprise a mineral comprising iron.
  • composition II does not comprise one or more antibodies.
  • compositions II of the present invention can be prepared by mixing the at least one HMO, and the at least one carotenoid, optionally the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally further components e.g. vitamins and related compounds thereto, carotenoids, medium chain fatty acids, long chain fatty acids, prebiotics, probiotics, phenolic compounds, herbals, minerals and the like and/or mixtures thereof, as known in the art.
  • the composition II does not comprise more than 80 wt% water.
  • the present invention provides a composition II which comprises i) at least one HMO, and ii) at least one carotenoid, and optionally iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, for use as a medicament, preferably as a medicament for mammals, birds, crustaceans and/or fishes, in particular as a medicament for mammals.
  • the term ’’mammals encompasses humans and nonhuman mammals.
  • non-human mammals are livestock, e.g. sheep, goats, pigs, cattles, horses, camels, llamas and the like, and pets, e.g. cats, dogs and the like.
  • composition II is for use as a medicament for humans.
  • composition II is for use as a medicament for livestock and/or pets.
  • composition II is for use as a medicament for birds, e.g. poultry (like chickens, ducks, geese, turkeys and the like) and ornamental birds (like canaries and the like).
  • birds e.g. poultry (like chickens, ducks, geese, turkeys and the like) and ornamental birds (like canaries and the like).
  • composition II is for use as a medicament for fishes, e.g. fishes used for consumption (like salmon, tuna, sardines, cod, trout, and the like) and ornamental fishes (like kois and the like).
  • fishes e.g. fishes used for consumption (like salmon, tuna, sardines, cod, trout, and the like) and ornamental fishes (like kois and the like).
  • composition II is for use as a medicament for crustaceans, e.g. crustaceans used for consumption (like crabs, lobsters, crayfish, shrimps, prawns, krill and the like) and ornamental crustaceans (like crabs, lobsters, crayfish, shrimps, prawns, krill and the like).
  • crustaceans used for consumption (like crabs, lobsters, crayfish, shrimps, prawns, krill and the like) and ornamental crustaceans (like crabs, lobsters, crayfish, shrimps, prawns, krill and the like).
  • compositions II of the present invention for use as a medicament can be administered orally, enterally or parenterally, preferably orally.
  • composition II for use as a medicament is an orally administrable composition.
  • the composition II comprises i) as component A 2’-FL, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, and optionally iii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, for use as a medicament, preferably as a medicament for humans. It is understood that the embodiments mentioned for the composition II shall be applicable for the compositions II for use as a medicament and the specific embodiments thereto.
  • the present invention provides a composition II which comprises i) at least one HMO, and ii) at least one carotenoid, and optionally iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, for the use in the treatment and/or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto, preferably of mammals, more preferably of humans.
  • the term ’’treatment” in the context of gastro-intestinal dysfunction and/or associated morbidities thereto means using an effective therapy or management to alleviate, reduce or cure the condition and/or disease (gastro-intestinal dysfunction and/or associated morbidities thereto) and/or symptoms thereof, as the case may be, in addition it also includes the stabilization of the condition and/or disease, as the case may be, in order not to worsen in the course of the respective condition and/or disease.
  • treatment is understood as using an effective therapy or management to stabilize, alleviate or reduce the condition and/or disease and/or symptoms thereof, as the case may be.
  • gastro-intestinal dysfunction and/or associated morbidities thereto means an effective therapy or management so that the condition and/or disease (gastro-intestinal dysfunction and/or associated morbidities thereto) does not de novo develop, manifest and/or symptoms thereof do not occur.
  • composition II is for use in the treatment of gastro intestinal dysfunction and/or associated morbidities thereto.
  • composition II is for use in the prevention of gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the term ’’gastro-intestinal dysfunction refers to a condition and/or disease, as the case may be, which is characterized by an abnormal function of the gastro intestinal system of a respective subject.
  • a person with gastro-intestinal dysfunction has a disturbance of digestion and absorption processes; disturbance of motility; disturbance of barrier function and immune system; disturbance of formation and deposition of feces.
  • the composition II is for use in the treatment or prevention of gastro-intestinal dysfunction of a human.
  • associated morbidities as well as the term ’’morbidities associated to” mean one or more conditions and/or diseases which are co-occurring to the primary condition or disease (gastro-intestinal dysfunction), or which are occurring later in the life of the subject who had earlier in his or her life said primary condition and/or disease (gastro intestinal dysfunction).
  • the composition II is for use in the treatment or prevention of an associated morbidity, e.g. an associated morbidity of the esophagus, which includes functional chest pain, functional heartburn, reflux hypersensitivity, globus, functional dysphagia, esophagitis, esophageal ulceration, esophageal cancer etc., an associated morbidity of the stomach, which includes functional dyspepsia, belching disorders, nausea, vomiting, rumination syndrome, dyspepsia, malnutrition, pernicious anemia, gastritis, gastroenteritis, diarrhea, Crohn’s disease, gastric stenosis, gastric ulcers, gastric cancer etc., an associated morbidity of the small intestine, which includes maldigestion, malnutrition, enteritis, enterocolitis, necrotizing enterocolitis diarrhea, constipation, Coeliac disease, tropical sprue, inflammatory bowel disease (IBD) which includes Crohn’s disease,
  • composition II is for use in the treatment or prevention of an associated morbidity of the esophagus, in particular of a human subject having gastro-intestinal dysfunction.
  • composition II is for use in the treatment or prevention of functional chest pain, functional heartburn, reflux hypersensitivity, globus, functional dysphagia, esophagitis, esophageal ulceration, esophageal cancer, in particular of a human subject having gastro-intestinal dysfunction.
  • composition II is for use in the treatment or prevention of an associated morbidity of the stomach, in particular of a human subject having gastro intestinal dysfunction.
  • composition II is for use in the treatment or prevention of functional dyspepsia, belching disorders, nausea, vomiting, rumination syndrome, dyspepsia, malnutrition, pernicious anemia, gastritis, gastroenteritis, diarrhea, Crohn’s disease, gastric stenosis, gastric ulcers, gastric cancer, in particular of a human subject having gastro intestinal dysfunction.
  • composition II is for use in the treatment or prevention of an associated morbidity of the small intestine, in particular of a human subject having gastro-intestinal dysfunction.
  • composition II is for use in the treatment or prevention of maldigestion, malnutrition, enteritis, enterocolitis, necrotizing enterocolitis diarrhea, constipation, Coeliac disease, tropical sprue, inflammatory bowel disease (IBD) which includes Crohn’s disease, ulcerative colitis and other inflammatory diseases, vitamin deficiency, mineral deficiency, trace element deficiency, fatty acid deficiency, amino acid deficiency, intestinal ulcers, intestinal cancer, in particular of a human subject having gastro-intestinal dysfunction.
  • IBD inflammatory bowel disease
  • composition II is for use in the treatment or prevention of an associated morbidity of the large intestine, in particular of a human subject having gastro-intestinal dysfunction.
  • composition II is for use in the treatment or prevention of diverticulitis, colitis, pseudomembranous colitis, diarrhea, constipation, irritable bowel syndrome (IBS), inflammatory bowel disease which includes Crohn’s disease, ulcerative colitis and other inflammatory diseases, colo-rectal ulcers, colo-rectal cancer, in particular of a human subject having gastro-intestinal dysfunction.
  • IBS irritable bowel syndrome
  • composition II for use in the treatment or prevention of gastro-intestinal dysfunction is an orally administrable composition, in particular for a human subject.
  • the composition II for use in the treatment or prevention of morbidities associated to gastro-intestinal dysfunction is an orally administrable composition, in particular for a human subject.
  • the composition II comprises i) at least one HMO, and ii) at least one carotenoid, for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto, in particular of a mammal, especially of gastro-intestinal dysfunction of a human or especially of morbidities associated to gastro-intestinal dysfunction.
  • the composition II comprises i) as component A 2’-FL, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto of a mammal, in particular of gastro-intestinal dysfunction of a human, or in particular of morbidities associated to gastro-intestinal dysfunction of a human.
  • the composition II for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto, in particular of a mammal, especially of gastro-intestinal dysfunction of a human or especially of morbidities associated to gastro-intestinal dysfunction of a human does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • the composition II comprises i) at least one HMO, and ii) at least one carotenoid, and iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto of a mammal, in particular of gastro-intestinal dysfunction of a human, or in particular of morbidities associated to gastro-intestinal dysfunction of a human.
  • the composition II comprises i) as component A 2’-FL, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, and iii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto of a mammal, in particular of gastro-intestinal dysfunction of a human, or in particular of morbidities associated to gastro-intestinal dysfunction of a human. It is understood that the embodiments mentioned for the composition II shall be applicable for the compositions II for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto and the specific embodiments thereto.
  • the present invention provides a method to treat a subject having a disease, in particular gastro-intestinal dysfunction and/or associated morbidities thereto, or to prevent a subject being suspected of having or being at risk of developing a disease, in particular gastro-intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the composition II which comprises i) at least one HMO, and ii) at least one carotenoid, and optionally iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • the composition II which comprises i) at least one HMO, and ii) at least one carotenoid, and optionally iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • said method is for treating a subject having gastro-intestinal dysfunction, in particular a human, or preventing a subject being suspected of having or being at risk of developing gastro-intestinal dysfunction, in particular a human.
  • said method is for treating a subject having morbidities associated to gastro-intestinal dysfunction, in particular a human, or preventing a subject being suspected of having or being at risk of developing morbidities associated to gastro-intestinal dysfunction, in particular a human.
  • said human subject is in the age of 12 years or older, preferably 18 years or older, more preferably 35 years or older, in particular 50 years or older, even more particular 60 years or older.
  • composition II can be administered, preferably orally, or that any of the “at least one HMO” and the “at least one carotenoid” and optional the “at least one C3-C4- alkane carboxylic acid or derivative(s) thereof’ and optional further components can be administered separately, preferably orally.
  • composition II comprises as the at least one HMO two or more HMOs these can be administered separately, preferably orally, and in case composition II comprises as the at least one carotenoid two or more carotenoids these can be administered separately, preferably orally, and in case composition II comprises as the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof two or more C3-C4-alkane carboxylic acid or derivative(s) thereof these can be administered separately, preferably orally.
  • the daily application rate of the at least one HMO is from 0.1 to 20.0 g, preferably from 1.0 to 15.0 g, more preferably from 2.0 to 10.0 g, in particular from 2.5 to 5.0 g.
  • the daily application rate of the at least one carotenoid is from 0.1 to 100 mg, preferably from 5 to 50 mg.
  • the daily application rate of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 0.1 to 10.0 g, preferably from 1.0 to 9.0 g, more preferably from 1.2 to 9.0 g, in particular from 2.0 to 8.0 g, especially from 2.5 to 6.0 g.
  • the propionic acid and/or a derivative thereof can be administered in an application rate from 0.1 to 6.0 g/day, preferably from 0.5 to 5.0 g/day, more preferably from 1 .0 to 4.0 g/day.
  • the butyric acid and/or a derivative thereof can be administered in an application rate from 0.1 to 9.0 g/day, preferably from 0.5 to 7.0 g/day, more preferably from 1 .0 to 5.0 g/day.
  • the daily application rate of propionic acid and/or a derivative thereof is from 0.1 to 4.0 g
  • the daily application rate of butyric acid and/or a derivative thereof is from 0.1 to 6.0 g
  • the daily application rate of propionic acid and/or a derivative thereof is from 0.5 to 4.0 g
  • the daily application rate of butyric acid and/or a derivative thereof is from 0.5 to 5.0 g
  • the daily application rate of propionic acid and/or a derivative thereof is from 1.0 to 3.0 g
  • the daily application rate of butyric acid and/or a derivative thereof is from 1 .5 to 4.0 g.
  • the present invention provides a method to treat a subject having a disease, in particular gastro-intestinal dysfunction and/or associated morbidities thereto, or to prevent a subject being suspected of having or being at risk of developing a disease, in particular gastro intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the composition II which comprises i) at least one HMO, and ii) at least one carotenoid.
  • the present invention provides a method to treat a subject having a disease, in particular gastro-intestinal dysfunction and/or associated morbidities thereto, or to prevent a subject being suspected of having or being at risk of developing a disease, in particular gastro intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the composition II which comprises i) as component A 2’-FL, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene.
  • the composition II which comprises i) as component A 2’-FL, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene.
  • the present invention provides a method to treat a subject having a disease, in particular gastro-intestinal dysfunction and/or associated morbidities thereto, or to prevent a subject being suspected of having or being at risk of developing a disease, in particular gastro intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of said composition II which does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • the present invention provides a method to treat a subject having a disease, in particular gastro-intestinal dysfunction and/or associated morbidities thereto, or to prevent a subject being suspected of having or being at risk of developing a disease, in particular gastro intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the composition II which comprises i) at least one HMO, and ii) at least one carotenoid, and iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • the composition II which comprises i) at least one HMO, and ii) at least one carotenoid, and iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • the present invention provides a method to treat a subject having a disease, in particular gastro-intestinal dysfunction and/or associated morbidities thereto, or to prevent a subject being suspected of having or being at risk of developing a disease, in particular gastro intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the composition II which comprises i) as component A 2’-FL, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, and iii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate.
  • the composition II which comprises i) as component A 2’-FL, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- car
  • composition II shall be applicable for the use of the composition II in this method accordingly and in the specific embodiments thereto.
  • the present invention provides the use of a composition II comprising i) at least one HMO, and ii) at least one carotenoid, and optionally iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, for the manufacture of a medicament, preferably for the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides the use of a composition II comprising i) at least one HMO, and ii) at least one carotenoid, for the manufacture of a medicament, preferably for the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides the use of a composition II comprising i) as component A 2’-FL, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, for the manufacture of a medicament, preferably for the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides the use of a composition II, which does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof, for the manufacture of a medicament, preferably for the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides the use of a composition II comprising i) at least one HMO, and ii) at least one carotenoid, and iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, for the manufacture of a medicament, preferably for the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides the use of a composition II comprising i) as component A 2’-FL, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, and iii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, for the manufacture of a medicament, preferably for the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the medicament manufactured as mentioned above is for treating a subject having gastro-intestinal dysfunction, in particular a human, or preventing a subject being suspected of having or being at risk of developing gastro-intestinal dysfunction, in particular a human.
  • the medicament manufactured as mentioned above is for treating a subject having morbidities associated to gastro-intestinal dysfunction, in particular a human, or preventing a subject being suspected of having or being at risk of developing morbidities associated to gastro-intestinal dysfunction, in particular a human.
  • composition II shall be applicable for the use of the composition II in this use accordingly and in the specific embodiments thereto.
  • the present invention provides a nutritional supplement comprising a composition II which comprises i) at least one HMO, and ii) at least one carotenoid, and optionally iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • the term “nutritional supplement” means a manufactured product intended to supplement a diet, in particular of subjects having, being suspected of having or being at risk of gastro-intestinal dysfunction and/or associated morbidities thereto.
  • nutritional supplements include “dietary supplements” and “medical foods”.
  • a dietary supplement is intended to supplement a diet, in particular of subjects having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto, however it needs not to be used under medical supervision.
  • a medical food is also intended to supplement a diet, in particular of subjects having, being suspected of having or being at risk of developing gastro intestinal dysfunction and/or associated morbidities thereto, but it is under medical supervision.
  • the terms “medical foods” and “food for special medical purpose” are interchangeable.
  • the nutritional supplement can comprise said composition II or that the nutritional supplement can comprise any of the “at least one HMO” and the “at least one carotenoid” and optional the “at least one C3-C4-alkane carboxylic acid or derivative(s) thereof’ and optional further components in separate form.
  • the nutritional supplement is a dietary supplement.
  • the nutritional supplement is a medical food.
  • the nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro intestinal dysfunction and/or associated morbidities thereto.
  • the nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro intestinal dysfunction. In another embodiment of the present invention the nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to gastro-intestinal dysfunction.
  • the daily application rate of the at least one HMO is from 0.1 to 20.0 g, preferably from 1.0 to 15.0 g, more preferably from 2.0 to 10.0 g, in particular from 2.5 to 5.0 g.
  • the daily application rate of the at least one carotenoid is from 0.1 to 100 mg, preferably from 5 to 50 mg.
  • the daily application rate of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is 0.1 to 10.0 g, preferably from 1.0 to 9.0 g, more preferably from 1.2 to 9.0 g, in particular from 2.0 to 8.0 g, especially from 2.5 to 6.0 g.
  • propionic acid and/or a derivative thereof can be administered in an application rate from 0.1 to 6.0 g/day, preferably from 0.5 to 5.0 g/day, more preferably from 1 .0 to 4.0 g/day.
  • butyric acid and/or a derivative thereof can be administered in an application rate from 0.1 to 9.0 g/day, preferably from 0.5 to 7.0 g/day, more preferably from 1.0 to 5.0 g/day.
  • the daily application rate of propionic acid and/or a derivative thereof is from 0.1 to 4.0 g
  • the daily application rate of butyric acid and/or a derivative thereof is from 0.1 to 6.0 g
  • the daily application rate of propionic acid and/or a derivative thereof is from 0.5 to 4.0 g
  • the daily application rate of butyric acid and/or a derivative thereof is from 0.5 to 5.0 g
  • the daily application rate of propionic acid and/or a derivative thereof is from 1 .0 to 3.0 g
  • the daily application rate of butyric acid and/or a derivative thereof is from 1.5 to 4.0 g.
  • said subject is a human, preferably in the age of 12 years or older, more preferably 18 years or older, even more preferably 35 years or older, in particular 50 years or older, even more in particular 60 years or older.
  • the nutritional supplement can be administered, preferably orally, or that any of the “at least one HMO” and the “at least one carotenoid” and the optional “at least one C3-C4-alkane carboxylic acid or derivative(s) thereof’ and optional further components can be administered separately, preferably orally.
  • the nutritional supplement comprises as at least one HMO two or more HMOs that these can be administered separately, preferably orally, and in case the nutritional supplement comprises as at least one carotenoids two or more carotenoids that these can be administered separately, preferably orally, and in case the nutritional supplement comprises as at least one C3-C4-alkane carboxylic acid or derivative(s) thereof two or more C3-C4-alkane carboxylic acid or derivative(s) thereof that these can be administered separately, preferably orally.
  • the present invention provides a nutritional supplement comprising a composition II which comprises i) at least one HMO, and ii) at least one carotenoid, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides a nutritional supplement comprising a composition II which comprises i) as component A 2’-FL, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • a nutritional supplement comprising a composition II which comprises i) as component A 2’-FL, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides a nutritional supplement comprising a composition II which does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides a nutritional supplement comprising a composition II which comprises i) at least one HMO, and ii) at least one carotenoid, and iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • a composition II which comprises i) at least one HMO, and ii) at least one carotenoid, and iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides a nutritional supplement comprising a composition II which comprises i) as component A 2’-FL, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, and iii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate.
  • said nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro intestinal dysfunction.
  • said nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to gastro-intestinal dysfunction.
  • the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the nutritional supplement which comprises a composition II comprising i) at least one HMO, and ii) at least one carotenoid, and optionally iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • the nutritional supplement which comprises a composition II comprising i) at least one HMO, and ii) at least one carotenoid, and optionally iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • said method is for the dietary management of a subject having, being suspected of having or being at risk of developing gastro-intestinal dysfunction.
  • said method is for the dietary management of a subject having, being suspected of having or being at risk of developing morbidities associated to gastro-intestinal dysfunction.
  • the nutritional supplement can comprise said composition II or that the nutritional supplement can comprise any of the “at least one HMO” and the “at least one carotenoid” and optional the “at least one C3-C4-alkane carboxylic acid or derivative(s) thereof’ and optional further components in separate form.
  • composition II comprises as the at least one HMO two or more HMOs these can be administered separately, preferably orally, and in case composition II comprises as the at least one carotenoid two or more carotenoids these can be administered separately, preferably orally, and in case composition II comprises as the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof two or more C3- C4-alkane carboxylic acid or derivative(s) thereof these can be administered separately, preferably orally.
  • the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the nutritional supplement which comprises a composition II comprising i) at least one HMO, and ii) at least one carotenoid.
  • the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the nutritional supplement which comprises a composition II comprising i) as component A 2’-FL, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene.
  • a composition II comprising i) as component A 2’-FL, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene.
  • the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the nutritional supplement which comprises a composition II, which does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the nutritional supplement which comprises a composition II comprising i) at least one HMO, and ii) at least one carotenoid, and iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the nutritional supplement which comprises a composition II comprising i) as component A 2’-FL, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, and iii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate.
  • said method is for the dietary management of a subject having, being suspected of having or being at risk of developing gastro-intestinal dysfunction.
  • said method is for the dietary management of a subject having, being suspected of having or being at risk of developing morbidities associated to gastro-intestinal dysfunction.
  • the present invention provides the use of a composition II comprising i) at least one HMO, and ii) at least one carotenoid, and optionally iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, for the manufacture of a nutritional supplement, preferably for the dietary management of subjects having, being at risk or developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides the use of a composition II comprising i) at least one HMO, and ii) at least one carotenoid, for the manufacture of a nutritional supplement, preferably for the dietary management of subjects having, being at risk or developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides the use of a composition II comprising i) as component A 2’-FL, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, for the manufacture of a nutritional supplement, preferably for the dietary management of subjects having, being at risk or developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides the use of a composition II, which does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof, for the manufacture of a nutritional supplement, preferably for the dietary management of subjects having, being at risk or developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides the use of a composition II comprising i) at least one HMO, and ii) at least one carotenoid, and iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, for the manufacture of a nutritional supplement, preferably for the dietary management of subjects having, being at risk or developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides the use of a composition II comprising i) as component A 2’-FL, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, and iii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, for the manufacture of a nutritional supplement, preferably for the dietary management of subjects having, being at risk or developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the nutritional supplement manufactured as mentioned above is for the dietary management of a subject having gastro-intestinal dysfunction, in particular a human, or a subject being suspected of having or being at risk of developing gastro-intestinal dysfunction, in particular a human.
  • the nutritional supplement manufactured as mentioned above is for the dietary management of a subject having gastro-intestinal dysfunction, in particular a human, or a subject being suspected of having or being at risk of developing gastro-intestinal dysfunction, in particular a human.
  • composition II shall be applicable for the use of the composition II in this use accordingly and in the specific embodiments thereto.
  • Both, the medicament (in general and for the respective specific use) and the nutritional supplement (in general and for the respective specific use) of the present invention can be delivered in any suitable format.
  • Formulations suitable for oral administration may be in the form of capsules, tablets, pills, dragees, lozenges (using a flavored basis, usually sucrose and acacia or tragacanth), powders, granules, and the like or as a solution or a suspension in an aqueous or non-aqueous liquid, or as an oil-in-water or water-in-oil liquid emulsion, or as an elixir or syrup, or as pastilles (using an inert base, such as gelatin and glycerin, or sucrose and acacia), each comprising a predetermined amount of the at least one HMO, the at least one carotenoid, optional the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof and optional further components.
  • the medicament in general and for the
  • active ingredients of said medicament and nutritional supplement can be delivered together in a respective suitable format or that each of component A and component C and optionally component B can be delivered in a respective format or that each of the active ingredients can be delivered in a respective format, or any combination thereof.
  • the desired components of the composition II may be mixed with one or more pharmaceutically acceptable carriers, such as sodium citrate or dicalcium phosphate, and/or any of the following: (1) fillers or extenders, such as starches, lactose, sucrose, glucose, mannitol, and/or silicic acid; (2) binders, such as carboxymethylcellulose, alginates, gelatin, polyvinyl pyrrolidone, sucrose and/or acacia; (3) humectants, such as glycerol; (4) disintegrating agents, such as agar- agar, calcium carbonate, potato or tapioca starch, alginic acid, certain silicates, and sodium carbonate; (5) solution retarding agents, such as paraffin; (6) absorption accelerators, such as quaternary ammonium compounds; (7) wetting agents, such as acetriglyceride
  • powders and/or granules can be reconstituted with water or another aqueous liquid prior to consumption.
  • the so obtained liquid does not comprise more than 80 wt% water.
  • liquid formulations do not comprise more than 80 wt% water.
  • the present invention provides a functional food comprising a composition II which comprises i) at least one HMO, and ii) at least one carotenoid, and optionally iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • a functional food means a food which is fortified with the composition II according to the present invention and intended to be used in a diet, in particular of subjects having, being suspected of having or being at risk of developing gastro intestinal dysfunction and/or associated morbidities thereto.
  • the terms “functional food” and “fortified food” are interchangeable.
  • Examples for foods being suitable for the preparation of functional foods are (1) dairy products e.g. yogurt, dessert, smoothie, milk and the like or mixtures thereof; (2) bakery products e.g. bread, rolls, pasta, cookie, cake, cereal bar and the like or mixtures thereof; (3) candy products e.g. candies, gummies, chewing gum, chocolate, pudding, cookie and the like or mixtures thereof; (4) beverage products e.g. fruit juice, vegetable juice, lemonade, water and the like or mixtures thereof.
  • dairy products e.g. yogurt, dessert, smoothie, milk and the like or mixtures thereof
  • bakery products e.g. bread, rolls, pasta, cookie, cake, cereal bar and the like or mixtures thereof
  • candy products e.g. candies, gummies, chewing gum, chocolate, pudding, cookie and the like or mixtures thereof
  • beverage products e.g. fruit juice, vegetable juice, lemonade, water and the like or mixtures thereof.
  • the functional food can comprise said composition II or that the functional food can comprise any of the “at least one HMO” and the “at least one carotenoid” and optional the “at least one C3-C4-alkane carboxylic acid or derivative(s) thereof’ and optional further components in separate form.
  • composition II comprises as the at least one HMO two or more HMOs these can be comprised separately in the functional food or together as composition
  • composition II comprises as the at least one carotenoid two or more carotenoids these can be comprised separately in the functional food or together as composition
  • composition II comprises as the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof two or more C3-C4-alkane carboxylic acid or derivative(s) thereof these can be comprised separately in the functional food or together as composition.
  • the functional food is for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the functional food is for use in the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to gastro-intestinal dysfunction.
  • the daily application rate of the at least one HMO is from 0.1 to 20.0 g, preferably from 1.0 to 15.0 g, more preferably from 2.0 to 10.0 g, in particular from 2.5 to 5.0 g.
  • the daily application rate of the at least one carotenoid is from 0.1 to 100 mg, preferably from 5 to 50 mg.
  • the daily application rate of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is 0.1 to 10.0 g, preferably from 1.0 to 9.0 g, more preferably from 1.2 to 9.0 g, in particular from 2.0 to 8.0 g, especially from 2.5 to 6.0 g.
  • propionic acid and/or a derivative thereof can be administered in an application rate from 0.1 to 6.0 g/day, preferably from 0.5 to 5.0 g/day, more preferably from 1 .0 to 4.0 g/day.
  • butyric acid and/or a derivative thereof can be administered in an application rate from 0.1 to 9.0 g/day, preferably from 0.5 to 7.0 g/day, more preferably from 1.0 to 5.0 g/day.
  • the daily application rate of propionic acid and/or a derivative thereof is from 0.1 to 4.0 g
  • the daily application rate of butyric acid and/or a derivative thereof is from 0.1 to 6.0 g
  • the daily application rate of propionic acid and/or a derivative thereof is from 0.5 to 4.0 g
  • the daily application rate of butyric acid and/or a derivative thereof is from 0.5 to 5.0 g
  • the daily application rate of propionic acid and/or a derivative thereof is from 1 .0 to 3.0 g
  • the daily application rate of butyric acid and/or a derivative thereof is from 1.5 to 4.0 g.
  • said subject is a human, preferably in the age of 12 years or older, more preferably 18 years or older, even more preferably 35 years or older, in particular 50 years or older, even more in particular 60 years and older.
  • the present invention provides a functional food comprising a composition II which comprises i) at least one HMO, and ii) at least one carotenoid, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides a functional food comprising a composition II which comprises i) as component A 2’-FL, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • a composition II which comprises i) as component A 2’-FL, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides a functional food comprising a composition II which does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides a functional food comprising a composition II which comprises i) at least one HMO, and ii) at least one carotenoid, and iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • the present invention provides a functional food comprising a composition II which comprises i) as component A 2’-FL, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, and iii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate.
  • a composition II which comprises i) as component A 2’-FL, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, and iii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate.
  • said functional food is for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro intestinal dysfunction.
  • said functional food is for use in the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to gastro-intestinal dysfunction.
  • the present invention provides a method for the dietary management of a subject having, being suspected to have or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the functional food which comprises a composition II comprising i) at least one HMO, and ii) at least one carotenoid, and optionally iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • a composition II comprising i) at least one HMO, and ii) at least one carotenoid, and optionally iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • said method is for the dietary management of a subject having, being suspected of having or being at risk of developing gastro-intestinal dysfunction. In another embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing morbidities associated to gastro-intestinal dysfunction.
  • the “at least one HMO” and the “at least one carotenoid” and optional the “at least one C3-C4-alkane carboxylic acid or derivative(s) thereof’ and optional further components can be comprised separately in the functional food or together as composition.
  • composition II comprises as at least one HMO two or more HMOs that these can be comprised separately in the functional food or together as composition
  • composition II comprises as at least one carotenoid two or more carotenoids that also these can be comprised separately in the functional food or together as composition
  • composition II comprises as at least one C3-C4-alkane carboxylic acid or derivative(s) thereof two or more C3- C4-alkane carboxylic acid or derivative(s) thereof that also these can be comprised separately in the functional food or together as composition.
  • the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the functional food which comprises a composition II comprising i) at least one HMO, and ii) at least one carotenoid.
  • the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of a functional food which comprises a composition II comprising i) as component A 2’-FL, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene.
  • a functional food which comprises a composition II comprising i) as component A 2’-FL, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene.
  • the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the functional food which comprises a composition II, which does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the functional food which comprises a composition II comprising i) at least one HMO, and ii) at least one carotenoid, and iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the functional food which comprises a composition II comprising i) as component A 2’-FL, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, and iii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate.
  • a composition II comprising i) as component A 2’-FL, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, and
  • said method is for the dietary management of a subject having, being suspected of having or being at risk of developing gastro-intestinal dysfunction.
  • said method is for the dietary management of a subject having, being suspected of having or being at risk of developing morbidities associated to gastro-intestinal dysfunction.
  • the present invention provides the use of a composition II comprising i) at least one HMO, and ii) at least one carotenoid, and optionally iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, for the manufacture of a functional food, preferably for the dietary management of subjects having, being at risk or developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides the use of a composition II comprising i) at least one HMO, and ii) at least one carotenoid, for the manufacture of a functional food, preferably for the dietary management of subjects having, being at risk or developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides the use of a composition II comprising i) as component A 2’-FL, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, for the manufacture of a functional food, preferably for the dietary management of subjects having, being at risk or developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides the use of a composition II, which does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof, for the manufacture of a functional food, preferably for the dietary management of subjects having, being at risk or developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides the use of a composition II comprising i) at least one HMO, and ii) at least one carotenoid, and iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, for the manufacture of afunctional food, preferably for the dietary management of subjects having, being at risk or developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides the use of a composition II comprising i) as component A 2’-FL, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, and iii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, for the manufacture of a functional food, preferably for the dietary management of subjects having, being at risk or developing gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the functional food manufactured as mentioned above is for the dietary management of a subject having gastro-intestinal dysfunction, in particular a human, or a subject being suspected of having or being at risk of developing gastro-intestinal dysfunction, in particular a human.
  • the nutritional supplement manufactured as mentioned above is for the dietary management of a subject having morbidities associated to gastro-intestinal dysfunction, in particular a human, or a subject being suspected of having or being at risk of developing morbidities associated to gastro-intestinal dysfunction, in particular a human.
  • composition II shall be applicable for the use of the composition II in this use accordingly and in the specific embodiments thereto.
  • the functional food of the present invention can be prepared by known techniques and it can have any suitable type of format such as (1) a dairy product e.g. yogurt, dessert, smoothie, milk and the like or mixtures thereof; (2) a bakery product e.g. bread, rolls, pasta, cookie, cake, cereal bar and the like or mixtures thereof; (3) a candy product e.g. candies, gummies, chewing gum, chocolate, pudding, cookie and the like or mixtures thereof; (4) a beverage product e.g. fruit juice, vegetable juice, lemonade, water and the like or mixtures thereof.
  • a dairy product e.g. yogurt, dessert, smoothie, milk and the like or mixtures thereof
  • a bakery product e.g. bread, rolls, pasta, cookie, cake, cereal bar and the like or mixtures thereof
  • a candy product e.g. candies, gummies, chewing gum, chocolate, pudding, cookie and the like or mixtures thereof
  • (4) a beverage product e.g. fruit juice, vegetable juice, lemonade
  • composition II the composition II for use as a medicament, the composition II for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto, the nutritional supplement and the functional food, in particular for use in the dietary management of gastro-intestinal dysfunction and/or associated morbidities thereto, respectively, as disclosed herein, can be co-administered to subjects receiving at least one pharmaceutical against said gastro-intestinal dysfunction and/or associated morbidities thereto.
  • Examples for pharmaceuticals used in the treatment of gastro-intestinal dysfunction are
  • - immunomodulators azathioprine, methotrexate, infliximab, adalimumab, certolizumab, vedolizumab, ustekinumab, natalizumab and the like.
  • the present invention provides a method to treat a subject having gastro-intestinal dysfunction and/or associated morbidities thereto, by administering to the subject a) an effective amount of a composition II, a composition II for use as a medicament, a composition II for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto, a nutritional supplement or a functional food, in particular for use in the dietary management of gastro-intestinal dysfunction and/or associated morbidities thereto, which comprises i) at least one HMO, and ii) at least one carotenoid, and optionally iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof; and b) an effective amount of at least one pharmaceutical suitable to treat said gastro-intestinal dysfunction and/or associated morbidities thereto, in particular, wherein the application rate of the at least one pharmaceutical suitable to treat said gastro-intestinal dysfunction and/or associated morbidities thereto is reduced compared to a treatment with the at least one pharmaceutical alone.
  • gastro-intestinal dysfunction and/or associated morbidities thereto is gastro-intestinal dysfunction and the pharmaceutical is
  • antibiotic cefaclor, cefuroxime, penicillin, amoxicillin and the like
  • an anti-inflammatory drug prednisone and the like
  • an immunomodulator azathioprine, methotrexate, infliximab, adalimumab, certolizumab, vedolizumab, ustekinumab, natalizumab and the like.
  • the present invention provides a composition
  • a composition comprising a) i) at least one HMO, and/or ii) at least one carotenoid, and/or iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof; and b) an effective amount of at least one pharmaceutical, in particular for use as a medicament, especially for use in the treatment of the gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides a composition
  • a composition comprising a) i) as component A 2’-FL, and/or ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, and/or iii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and/or sodium butyrate; and b) an antibiotic (like cefaclor, cefuroxime, penicillin, amoxicillin and the like), an anti-inflammatory drug (like prednisone and the like), and/or an immunomodulator (like azathioprine, methotrexate, infliximab, adalimumab, certolizumab, vedolizumab, ustekinumab, natalizumab and the like) in a pharmaceutical effective amount
  • the present invention provides a composition
  • a composition comprising a) as component A at least one HMO, preferably 2’-FL, and b) an antibiotic (like cefaclor, cefuroxime, penicillin, amoxicillin and the like), an anti-inflammatory drug (like prednisone and the like), and/or an immunomodulator (like azathioprine, methotrexate, infliximab, adalimumab, certolizumab, vedolizumab, ustekinumab, natalizumab and the like) in a pharmaceutical effective amount, without any carotenoid, in particular for use as a medicament, especially for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto.
  • an antibiotic like cefaclor, cefuroxime, penicillin, amoxicillin and the like
  • an anti-inflammatory drug like prednisone and the like
  • an immunomodulator like azathioprine, methotre
  • the present invention provides a composition
  • a composition comprising a) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, and b) an antibiotic (like cefaclor, cefuroxime, penicillin, amoxicillin and the like), an anti-inflammatory drug (like prednisone and the like), and/or an immunomodulator (like azathioprine, methotrexate, infliximab, adalimumab, certolizumab, vedolizumab, ustekinumab, natalizumab and the like) in a pharmaceutical effective amount, without any HMO, in particular for use as a medicament, especially for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto.
  • an antibiotic like cefaclor, cefuroxime, penicillin, amox
  • the present invention provides a composition
  • a composition comprising a) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and/or sodium butyrate, and b) an antibiotic (like cefaclor, cefuroxime, penicillin, amoxicillin and the like), an anti-inflammatory drug (like prednisone and the like), and/or an immunomodulator (like azathioprine, methotrexate, infliximab, adalimumab, certolizumab, vedolizumab, ustekinumab, natalizumab and the like) in a pharmaceutical effective amount, without any carotenoids and/or without HMO, in particular for use as a medicament, especially for use in the treatment or prevention for of gastro-intestinal dysfunction and/or associated morbidities thereto.
  • an antibiotic like cefaclor, cefuroxime, penicillin, amoxicillin and the like
  • an anti-inflammatory drug
  • the composition II, the composition II for use as a medicament, the composition II for use in the treatment or prevention of gastro-intestinal dysfunction, the nutritional supplement or a functional food, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro-intestinal dysfunction, especially of subjects having gastro-intestinal dysfunction, used in said method comprises 2’-FL, and/or beta-carotene, lycopene, lutein and/or meso-zeaxanthin, and/or propionic acid and/or butyric acid or derivative(s) thereof, preferably 2’-FL, beta-carotene and/or lutein, especially beta-carotene, and/or optionally preferably sodium propionate and sodium butyrate.
  • composition II in another embodiment the composition II, the composition II for use as a medicament, the composition II for use in the treatment or prevention of a morbidity associated to gastro-intestinal dysfunction, the nutritional supplement or a functional food, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing a morbidity associated to gastro-intestinal dysfunction, especially of a subject having a morbidity associated to gastro-intestinal dysfunction, used in said method comprises 2’-FL, and/or beta-carotene, lycopene, lutein and/or meso-zeaxanthin, and/or optionally propionic acid and/or butyric acid or derivative(s) thereof, preferably 2’-FL, beta-carotene and/or lutein, especially beta-carotene, and/or optionally preferably sodium propionate and sodium butyrate.
  • the nutritional supplement or the functional food is for use in the dietary management of gastro-intestinal dysfunction.
  • the nutritional supplement or the functional food is for use in the in the dietary management of a morbidity associated to gastro-intestinal dysfunction.
  • the nutritional supplement or the functional food is for use in the in the dietary management of an associated morbidity of the esophagus, in particular of a human subject having or being suspected of having or at risk of developing gastro-intestinal dysfunction.
  • the nutritional supplement or the functional food is for use in the in the dietary management of functional chest pain, functional heartburn, reflux hypersensitivity, globus, functional dysphagia, esophagitis, esophageal ulceration, esophageal cancer, in particular of a human subject having or being suspected of having or at risk of developing gastro-intestinal dysfunction.
  • the nutritional supplement or the functional food is for use in the in the dietary management of an associated morbidity of the stomach, in particular of a human subject having or being suspected of having or at risk of developing gastro-intestinal dysfunction.
  • the nutritional supplement or the functional food is for use in the in the dietary management of functional dyspepsia, belching disorders, nausea, vomiting, rumination syndrome, dyspepsia, malnutrition, pernicious anemia, gastritis, gastroenteritis, diarrhea, Crohn’s disease, gastric stenosis, gastric ulcers, gastric cancer, in particular of a human subject having or being suspected of having or at risk of developing gastro-intestinal dysfunction.
  • the nutritional supplement or the functional food is for use in the in the dietary management of an associated morbidity of small intestine, in particular of a human subject having or being suspected of having or at risk of developing gastro-intestinal dysfunction.
  • the nutritional supplement or the functional food is for use in the in the dietary management of maldigestion, malnutrition, enteritis, enterocolitis, necrotizing enterocolitis diarrhea, constipation, Coeliac disease, tropical sprue, inflammatory bowel disease (IBD) which includes Crohn’s disease, ulcerative colitis and other inflammatory diseases, vitamin deficiency, mineral deficiency, trace element deficiency, fatty acid deficiency, amino acid deficiency, intestinal ulcers, intestinal cancer, in particular of a human subject having or being suspected of having or at risk of developing gastro-intestinal dysfunction.
  • IBD inflammatory bowel disease
  • the nutritional supplement or the functional food is for use in the in the dietary management of an associated morbidity of the large intestine, in particular of a human subject having or being suspected of having or at risk of developing gastro intestinal dysfunction.
  • the nutritional supplement or the functional food is for use in the in the dietary management of diverticulitis, colitis, pseudomembranous colitis, diarrhea, constipation, irritable bowel syndrome (IBS), inflammatory bowel disease which includes Crohn’s disease, ulcerative colitis and other inflammatory diseases, colo-rectal ulcers, colo-rectal cancer, in particular of a human subject having or being suspected of having or at risk of developing gastro intestinal dysfunction.
  • IBS irritable bowel syndrome
  • kits for the pharmaceutical use or dietary management use comprising a first component comprising at least one HMO and a second component comprising at least one carotenoid and optionally a third component comprising at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • the present invention provides a kit for the pharmaceutical use or dietary management use comprising a first component comprising 2’-FL, and a second component comprising astaxanthin, alpha-carotene, beta-carotene, beta-cryptoxanthin, lycopene, lutein, meso- zeaxanthin and/or zeaxanthin, preferably beta-carotene and/or lutein, especially beta-carotene, and optionally a third component comprising propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate.
  • the present invention provides a kit for the pharmaceutical use or dietary management use comprising a first component comprising 2’-FL, a second component comprising astaxanthin, alpha-carotene, beta-carotene, beta-cryptoxanthin, lycopene, lutein, meso-zeaxanthin and/or zeaxanthin, preferably beta-carotene and/or lutein, especially beta-carotene, and a third component comprising propionic acid or derivative(s) thereof, preferably sodium propionate and a forth component comprising butyric acid or derivative(s) thereof, preferably sodium butyrate.
  • a kit for the pharmaceutical use or dietary management use comprising a first component comprising 2’-FL, a second component comprising astaxanthin, alpha-carotene, beta-carotene, beta-cryptoxanthin, lycopene, lutein, meso-zeaxanthin and/or zeaxanthin,
  • the present invention provides said kit for the pharmaceutical use for the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto or for the dietary management use of the dietary management of subjects having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto, in particular subjects having gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the present invention provides said kit for the pharmaceutical use for the treatment or prevention of gastro-intestinal dysfunction or for the dietary management use of the dietary management of subjects having, being suspected of having or being at risk of developing gastro-intestinal dysfunction, in particular subjects having gastro-intestinal dysfunction.
  • the present invention provides said kit for the pharmaceutical use for the treatment or prevention of morbidities associated to gastro-intestinal dysfunction or for the dietary management use of the dietary management of subjects having, being suspected of having or being at risk of developing associated morbidities to gastro-intestinal dysfunction, in particular subjects having associated morbidities to gastro-intestinal dysfunction.
  • kits for the pharmaceutical use comprising a first component comprising at least one HMO, and a second component comprising a pharmaceutical, preferably a pharmaceutical for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto, and optionally a third component comprising at least one carotenoid.
  • the present invention provides a kit for the pharmaceutical use comprising a first component which is 2’-FL, a second component comprising an antibiotic (like cefaclor, cefuroxime, penicillin, amoxicillin and the like), an anti-inflammatory drug (like prednisone and the like), and/or an immunomodulator (like azathioprine, methotrexate, infliximab, adalimumab, certolizumab, vedolizumab, ustekinumab, natalizumab and the like) in a pharmaceutical effective amount, and optionally beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta-carotene and/or lutein, especially beta-carotene.
  • an antibiotic like cefaclor, cefuroxime, penicillin, amoxicillin and the like
  • an anti-inflammatory drug like prednisone and the like
  • an immunomodulator like aza
  • kits for the pharmaceutical use comprising a first component comprising at least one carotenoid, and a second component comprising a pharmaceutical, preferably a pharmaceutical for use in the treatment or prevention of gastro intestinal dysfunction and/or associated morbidities thereto, and optionally a third component comprising at least one HMO.
  • the present invention provides a kit for the pharmaceutical use comprising a first component which is beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, a second component comprising an antibiotic (like cefaclor, cefuroxime, penicillin, amoxicillin and the like), an anti-inflammatory drug (like prednisone and the like), and/or an immunomodulator (like azathioprine, methotrexate, infliximab, adalimumab, certolizumab, vedolizumab, ustekinumab, natalizumab and the like) in a pharmaceutical effective amount, and optionally a third component which is 2’-FL.
  • a third component which is 2’-FL.
  • kits for the pharmaceutical use comprising a first component comprising at least one at least one C3-C4-alkane carboxylic acid or derivative(s) thereof and a second component comprising a pharmaceutical, preferably a pharmaceutical for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto, and optionally a third component comprising at least one HMO and/or at least one carotenoid.
  • the present invention provides a kit for the pharmaceutical use comprising a first component which is propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, a second component comprising an antibiotic (like cefaclor, cefuroxime, penicillin, amoxicillin and the like), an anti-inflammatory drug (like prednisone and the like), and/or an immunomodulator (like azathioprine, methotrexate, infliximab, adalimumab, certolizumab, vedolizumab, ustekinumab, natalizumab and the like) in a pharmaceutical effective amount, and optionally a third component 2’-FL, and/or optionally a third component which is beta- carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta-carotene and/or lutein, especially beta-carotene.
  • the present invention provides a kit for the pharmaceutical use comprising a first component comprising at least one HMO and a second component comprising a pharmaceutical, preferably a pharmaceutical for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto , and a third component comprising at least one carotenoid and a forth component comprising at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • the present invention provides a kit for the pharmaceutical use comprising a first component which is 2’-FL, a second component comprising an antibiotic (like cefaclor, cefuroxime, penicillin, amoxicillin and the like), an anti-inflammatory drug (like prednisone and the like), and/or an immunomodulator (like azathioprine, methotrexate, infliximab, adalimumab, certolizumab, vedolizumab, ustekinumab, natalizumab and the like) in a pharmaceutical effective amount, a third component which is beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, and a forth component which is propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate.
  • an antibiotic like cefaclor,
  • butyric acid denotes n-butyric acid and the term “butyrate” denotes n-butyrate.
  • the term ”at least one HMO” is interchangeable with the term ’’component A
  • the term ”at least one C3-C4-alkane carboxylic acid or a derivative thereof’ is interchangeable with the term “component B”
  • the term “at least one carotenoid” is interchangeable with the term “component C”.
  • composition comprises several components that these can also be administered separately.
  • these components can be administered together or separately, as the case may be.
  • compositions of the present invention can comprise, consist of, or consist essentially of the essential elements and limitations of the invention described herein, as well as any additional or optional ingredients, components, or limitations described herein or otherwise depending on the needs.
  • the terminology as set forth herein is for description of the embodiments only and should not be construed as limiting the disclosure as a whole. In a particular embodiment the compositions of the invention consist essentially of the essential elements, and even more particular consist of the essential elements.
  • composition II comprising i) at least one HMO, and ii) at least one carotenoid, and optionally iii) at least one C3-C4-alkane carboxylic acid or a derivative thereof.
  • composition II according to any one of embodiments 1-11 to 3-11, wherein one of the at least one HMO’s is a sialylated oligosaccharide.
  • composition II according to any one of embodiments embodiment 1-11 to 4-11, wherein one of the at least one HMO is 6’-sialyllactose (6’-SL).
  • composition II according to any one of embodiments 1-11 to 5-11, wherein one of the at least one HMO’s is a N-acetylated oligosaccharide.
  • composition II according to any one of embodiments 1-11 to 6-11, wherein one of the at least one HMO is lacto-N-tetraose (LNT).
  • LNT lacto-N-tetraose
  • composition II according to any one of embodiments 1-11 to 7-11, wherein the at least one
  • HMO is one or more HMOs selected from the group consisting of 2’-FL, 3-FL, difucosyllactose (in particular 2’,2”-DiFL and/or 3, 2’-DiFL), LNT, LNnT, 3’-SL and 6’-SL.
  • composition II according to any one of embodiments 1-11 to 8-11, wherein the at least one
  • HMO is one, two or three HMOs selected from the group consisting of 2’-FL, 3-FL, difucosyllactose (in particular 2’, 2”-DiFL and/or 3, 2’-DiFL), LNT, LNnT, 3’-SL and 6’-SL.
  • composition II according to any one of embodiments 1-11 to 9-11, wherein the at least one
  • HMO is one, two or three HMOs selected from the group consisting of 2’-FL, LNT, LNnT, 3’-SL and 6’-SL.
  • composition II according to any one of embodiments 1-11 to 9-11, wherein the at least one
  • HMO is one, two or three HMOs selected from the group consisting of 2’-FL, 2’,2”-DiFL and 3,2’-DiFL.
  • composition II according to any one of embodiments 1-11 to 11-11 wherein the at least one
  • HMO is 2’-FL. 13-11.
  • composition II according to any one of embodiments 1-11 to 14-11, wherein one of the at least one carotenoid is beta-carotene.
  • composition II according to any one of embodiments 1-11 to 15-11, wherein one of the at least one carotenoid is lutein.
  • composition II according to any one of embodiments 1-11 to 16-11 which does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • composition II according to any one of embodiments 1-11 to 16-11 which comprise at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.
  • composition II according to any one of embodiments 1-11 to 18-11, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is propionic acid or a derivative thereof.
  • composition II according to any one of embodiments 1-11 to 19-11, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is a physiologically acceptable salt or ester of propionic acid.
  • composition II according to any one of embodiments 1-11 to 20-11, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is an alkali salt or an alkaline earth salt of propionic acid.
  • composition II according to any one of embodiments 1-11 to 21-11, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is a sodium or potassium salt of propionic acid.
  • composition II according to any one of embodiments 1-11 to 22-11 wherein the at least one
  • C3-C4-alkane carboxylic acid or a derivative thereof is sodium or potassium propionate.
  • 24-II The composition II according to any one of embodiments 1-11 to 20-11, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is a C1-C6 alkyl ester or a mono- or diglyceride of propionic acid.
  • composition II according to any one of embodiments 1-11 to 24-11, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is butyric acid or a derivative thereof.
  • composition II according to any one of embodiments 1-11 to 25-11, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is a physiologically acceptable salt or ester of butyric acid.
  • composition II according to any one of embodiments 1-11 to 26-11, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is an alkali salt or an alkaline earth salt of butyric acid.
  • composition II according to any one of embodiments 1-11 to 27-11, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is sodium or potassium salt of butyric acid.
  • composition II according to any one of embodiments 1-11 to 28-11 wherein the at least one
  • C3-C4-alkane carboxylic acid or a derivative thereof is a sodium or potassium butyrate.
  • composition II according to any one of embodiments 1-11 to 26-11, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is a C1-C6 alkyl ester or a mono- or diglyceride of butyric acid.
  • composition II according to any one of embodiments 1-11 to 30-11, wherein the at least one
  • C3-C4-alkane carboxylic acid or a derivative thereof is propionic acid or a derivative thereof and butyric acid or a derivative thereof.
  • composition II according to any one of embodiments 1-11 to 31-11, wherein the at least one
  • C3-C4-alkane carboxylic acid or a derivative thereof is a physiologically acceptable salt of propionic acid and physiologically acceptable salt of butyric acid.
  • composition II according to any one of embodiments 1-11 to 32-11, wherein the at least one
  • C3-C4-alkane carboxylic acid or a derivative thereof is an alkali salt or an alkaline earth salt of propionic acid and an alkali salt or an alkaline earth salt of butyric acid.
  • 34-II The composition II according to any one of embodiments 1-11 to 33-11, wherein the at least one
  • C3-C4-alkane carboxylic acid or a derivative thereof is a sodium or potassium salt of propionic acid and a sodium or potassium salt of butyric acid.
  • composition II according to any one of embodiments 1-11 to 34-11 wherein the at least one
  • C3-C4-alkane carboxylic acid or a derivative thereof is sodium or potassium propionate and sodium or potassium butyrate.
  • composition II according to any one of embodiments 1-11 to 31-11, wherein the at least one
  • C3-C4-alkane carboxylic acid or a derivative thereof is a physiologically acceptable ester of propionic acid and a physiologically acceptable ester of butyric acid.
  • composition II according to any one of embodiments 1-11 to 36-11, wherein the at least one
  • C3-C4-alkane carboxylic acid or a derivative thereof is a C1-C6 alkyl ester or a mono- or diglyceride of propionic acid and a C1 -C6 alkyl ester or a mono- or diglyceride of butyric acid.
  • composition II according to any one of embodiments 1-11 to 37-11, wherein the weight to weight ratio of the at least one HMO (component A): the at least one carotenoid (component C) is from 1 :1 to 200000:1.
  • composition II according to any one of embodiments 1-11 to 38-11, wherein the weight to weight ratio of the at least one HMO (component A): the at least one C3-C4 alkane carboxylic acid or a derivative thereof (component B) is from 100:1 to 1 :100.
  • composition II according to any one of embodiments 1-11 to 39-11, wherein the weight to weight ratio of (component A) : (component B) is from 20:1 to 1 :20, preferably from 10:1 to 1 :10, more preferably from 3:1 to 1 :3, in particular from 2:1 to 1 :2.
  • composition II according to any one of embodiments 31-11 to 40-11, wherein the weight to weight ratio of the propionic acid or a derivative thereof : butyric acid or a derivative thereof is from 100:1 to 1 : 100.
  • composition II according to any one of embodiments 31-11 to 41-11, wherein the weight to weight ratio of the propionic acid or a derivative thereof : butyric acid or a derivative thereof is from 20:1 to 1 :20, preferably from 10:1 to 1 :15, more preferably from 2:1 to 1 :8.
  • composition II according to any one of embodiments 1-11 to 42-11, wherein the weight to weight ratio of (component B) : (component C) is from 1 :1 to 200000:1 .. 44-II.
  • HMO and the at least one carotenoid are present in synergistic amounts.
  • composition II according to any one of embodiments 1-11 to 44-11, wherein the at least one
  • HMO and the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof are present in synergistic amounts.
  • composition II according to any one of embodiments 1-11 to 45-11, wherein the at least one carotenoid and the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof are present in synergistic amounts.
  • composition II according to any one of embodiments 1-11 to 46-11, wherein the at least one
  • HMO and the at least one carotenoid and the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof are present in synergistic amounts.
  • composition II according to any one of embodiments 1-11 to 47-11, wherein the total amount of the at least one HMO and the at least one carotenoid and optionally the at least one C3-C4- alkane carboxylic acid or derivative(s) thereof is from 1 to 100 wt% of the total composition II, preferably from 10 to 100 wt%.
  • composition II according to any one of embodiments 1-11 to 48-11, wherein the total amount of the at least one HMO is from 10 to 99.99999 wt% of the total composition II, preferably from 20 to 99.9999 wt%, more preferably from 30 to 99.999 wt%, even more preferably from 40 to 99.9 wt%.
  • composition II according to any one of embodiments 1-11 to 48-11, wherein the total amount of the at least one HMO is from 5 to 50 wt% of the total composition II, preferably from 8 to 40 wt%, more preferably from 10 to 35 wt%, even more preferably from 15 to 30 wt%.
  • composition II according to any one of embodiments 1-11 to 49-11, wherein the total amount of the at least one HMO is from 50 to 95 wt% of the total composition II, preferably from 55 to 80 wt%, more preferably from 60 to 75 wt%.
  • composition II according to any one of embodiments 1-11 to 51-11, wherein the total amount of the at least one carotenoid is from 0.0005 to 50 wt% of the total composition I, preferably from 0.005 to 5.0 wt%, more preferably from 0.05 to 0.5 wt%, even more preferably from 0.5 to 4 wt%, even more preferably from 0.1 to 4 wt%, even more preferably from 0.1 to 3 wt%, even more preferably from 0.1 to 2 wt%, even more preferably from 0.1 to 1 wt%. 53-II.
  • composition II according to any one of embodiments 1-11 to 52-11, wherein the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 10 to 90 wt% of the total composition II, preferably from 15 to 85 wt%, more preferably from 20 to 75 wt%, even more preferably from 25 to 60 wt%.
  • composition II according to any one of embodiments 1-11 to 52-11, wherein the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 10 to 50 wt% of the total composition II, preferably from 15 to 45 wt%, more preferably from 20 to 35 wt%.
  • composition II according to any one of embodiments 1 to 52-II, wherein the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 50 to 90 wt% of the total composition II, preferably from 55 to 80 wt%, more preferably from 60 to 75 wt%.
  • composition II according to any one of embodiments 1-11 to 55-11, wherein the composition
  • composition II according to embodiment 56-11 wherein the one or more vitamins or related compounds thereto are selected from the group of vitamin A, vitamin B1 , vitamin B2, vitamin B3, pantothenic acid, vitamin B6, biotin, folic acid, vitamin B12, vitamin E, vitamin K, vitamin C and vitamin D, or related compounds thereto and/or mixtures thereof.
  • composition II according to embodiment 57-I, wherein the one or more vitamins or related compounds thereto is a vitamin D compound.
  • composition II according to embodiment 58-II wherein the vitamin D compound relates to calciferol, cholecalciferol, 1 ,25-dihydroxyvitamin D and/or ergocaliferol, preferably cholecalciferol and/or ergocaliferol, preferably cholecalciferol.
  • composition II according to any one of embodiments 1-11 to 59-11, wherein the composition
  • II further comprises one or more medium-chain fatty acids, in free form, as glyceride, phospholipid, alkyl ester and/or mixtures thereof.
  • composition II according to embodiment 60-11, wherein the one or more medium chain fatty acids are selected from the group of caproic acid, caprylic acid, capric acid, lauric acid and/or mixtures.
  • composition II according to any one of embodiments 1-11 to 61-11, wherein the composition
  • composition II further comprises one or more long-chain fatty acids, in free form, as glyceride, phospholipid, alkyl ester and/or mixtures thereof.
  • one or more long chain fatty acids are selected from the group of saturated long chain fatty acids, mono-unsaturated long chain fatty acids, polyunsaturated long chain fatty acids and/or mixtures thereof.
  • composition II according to any one of embodiments 1-11 to 63-11, wherein the composition
  • II further comprises one or more prebiotics.
  • composition II according to embodiment 64-11, wherein the one or more prebiotics are selected from the group of water-insoluble fibers, water-soluble fibers and/or mixtures thereof.
  • composition II according to any one of embodiments 1-11 to 65-11, wherein the composition
  • II further comprises one or more probiotics.
  • composition II according to embodiment 66-11, wherein the one or more probiotics are selected from the group of the family Lactobacilaceae, preferably of the genus Lactobacillus, in particular of the species lactobacillus acidophilus, lactobacillus alimentarius, lactobacillus casei, lactobacillus delbrueckii, lactobacillus helveticus, lactobacillus plantarum, lactobacillus reuteri, lactobacillus rhamnosus, lactobacillus salivarius, of the genus Bifidobacterium, in particular of the species bifidobacterium animalis, bifidobacterium bifidum, bifidobacterium breve, bifidobacterium infantis, bifidobacterium lactis, bifidobacterium longum, of the genus Pediococcus, in particualar of the group of the family
  • composition II according to any one of embodiments 1-11 to 67-11, wherein the composition
  • composition II according to embodiment 68-11 wherein the one or more phenolic compounds are selected from the group of monophenols, flavonoids, isoflavonoids, aurones, chalconoids, flavonolignans, lignans, phytoestrogens, stilbenoids, piceatannol, curcuminoids, tannins, aromatic acids, phenylethanoids, capsaicin, gingerol, alkylresorcinol and/or mixtures thereof.
  • composition II according to any one of embodiments 1-11 to 69-11, wherein the composition
  • composition II further comprises one or more herbals. 71-11.
  • composition II according to any one of embodiments 1-11 to 71-11, wherein the composition
  • II further comprises one or more minerals.
  • composition II according to any one of embodiments 1-11 to 72-11, wherein the composition does not comprise an antibody.
  • composition II as described in any one of the embodiments 1-11 to 73-11 for use as a medicament preferably as a medicament for mammals, birds, crustaceans and/or fishes, more preferably for mammals, even more preferably for humans.
  • composition II as described in any one of embodiments 1-11 to 73-11 for use in the treatment and/or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto, preferably of mammals, birds, crustaceans and/or fishes, more preferably of mammals, even more preferably of humans.
  • composition II according to embodiment 75-11, wherein the gastro-intestinal dysfunction and/or associated morbidities thereto is gastro-intestinal dysfunction, in particular of a human.
  • composition II according to embodiment 76-11 wherein the gastro-intestinal dysfunction is a disturbance of digestion and absorption processes; disturbance of motility; disturbance of barrier function and immune system; disturbance of formation and deposition of feces, in particular of a human.
  • composition II as described in any one of embodiments 1-11 to 79-11, wherein the associated morbidity is maldigestion, malnutrition, enteritis, enterocolitis, necrotizing enterocolitis diarrhea, constipation, Coeliac disease, tropical sprue, inflammatory bowel disease (IBD) which includes Crohn’s disease, ulcerative colitis and other inflammatory diseases, vitamin deficiency, mineral deficiency, trace element deficiency, fatty acid deficiency, amino acid deficiency, intestinal ulcers, intestinal cancer of a subject, in particular a human, even more particular a human having gastro-intestinal dysfunction.
  • IBD inflammatory bowel disease
  • IBS irritable bowel syndrome
  • composition II according to any one of embodiments 74-11 to 83-11, wherein the composition II is an orally administrable composition.
  • a method for treating a subject having, suspected of having or being at risk of developing a disease, in particular gastro-intestinal dysfunction and/or associated morbidities thereto comprising administering to the subject an effective amount of a composition II according to any one of embodiments 1-11 to 73-11.
  • the method according to any one of embodiments 85-II to 89-II, wherein the application rate of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 0.1 to 10.0 g/day, preferably from 1.0 to 9.0 g/day, more preferably from 1.2 to 9.0 g/day, in particular from 2.0 to 8.0 g/day, especially from 2.5 to 6.0 g/day.
  • C4-alkane carboxylic acid or derivative(s) thereof is a mixture of propionic acid or a derivative thereof and butyric acid or a derivative thereof and the application rate of propionic acid and/or a derivative thereof is from 0.1 to 4.0 g/day and the application rate of butyric acid and/or a derivative thereof is from 0.1 to 6.0 g/day, preferably the application rate of propionic acid and/or a derivative thereof is from 0.5 to 4.0 g/day, and the application rate of butyric acid and/or a derivative thereof is from 0.5 to 5.0 g/day, more preferably the application rate of propionic acid and/or a derivative thereof is from 1 .0 to 3.0 g/day, and the application rate of butyric acid and/or a derivative thereof is from 1.5 to 4.0 g/day.
  • a nutritional supplement or a functional food comprising a composition II according to any one of embodiments 1-11 to 73-11.
  • 96-II The nutritional supplement or the functional food according to embodiment 95-II for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto, preferably of mammals, birds, crustaceans and/or fishes, more preferably of mammals, even more preferably of humans.
  • the nutritional supplement or functional food according to embodiment 96-II for use in the dietary management of subjects having, being suspected of having or being at risk of developing gastro-intestinal dysfunction, preferably of mammals, birds, crustaceans and/or fishes, more preferably of mammals, even more preferably of humans.
  • the nutritional supplement or functional food according to embodiment 96-II for use in the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to gastro-intestinal dysfunction, preferably of mammals, birds, crustaceans and/or fishes, more preferably of mammals, even more preferably of humans.
  • the nutritional supplement or functional food according to embodiment 98-II for use in the dietary management of subjects having, being suspected of having or being at risk of developing an associated morbidity of the esophagus, an associated morbidity of the stomach, an associated morbidity of the small intestine or an associated morbidity of the large intestine, in particular of a human, even more particular of a human having gastro-intestinal dysfunction.
  • the nutritional supplement or functional food according to embodiment 99-11 for use in the dietary management of subjects having, being suspected of having or being at risk of developing functional chest pain, functional heartburn, reflux hypersensitivity, globus, functional dysphagia, esophagitis, esophageal ulceration, esophageal cancer, in particular of a human, even more particular of a human having gastro-intestinal dysfunction.
  • the nutritional supplement or functional food according to embodiment 99-11 for use in the dietary management of subjects having, being suspected of having or being at risk of developing functional dyspepsia, belching disorders, nausea, vomiting, rumination syndrome, dyspepsia, malnutrition, pernicious anemia, gastritis, gastroenteritis, diarrhea, Crohn’s disease, gastric stenosis, gastric ulcers, gastric cancer, in particular of a human, even more particular of a human having gastro-intestinal dysfunction.
  • the nutritional supplement or functional food according to embodiment 99-II for use in the dietary management of subjects having, being suspected of having or being at risk of developing maldigestion, malnutrition, enteritis, enterocolitis, necrotizing enterocolitis diarrhea, constipation, Coeliac disease, tropical sprue, inflammatory bowel disease (IBD) which includes Crohn’s disease, ulcerative colitis and other inflammatory diseases, vitamin deficiency, mineral deficiency, trace element deficiency, fatty acid deficiency, amino acid deficiency, intestinal ulcers, intestinal cancer, in particular of a human, even more particular of a human having gastro-intestinal dysfunction.
  • IBD inflammatory bowel disease
  • the nutritional supplement or functional food according to embodiment 99-II for use in the dietary management of subjects having, being suspected of having or being at risk of developing diverticulitis, colitis, pseudomembranous colitis, diarrhea, constipation, irritable bowel syndrome (IBS), inflammatory bowel disease which includes Crohn’s disease, ulcerative colitis and other inflammatory diseases, colo-rectal ulcers, colo-rectal cancer, in particular of a human, even more particular of a human having gastro-intestinal dysfunction.
  • IBS irritable bowel syndrome
  • a method for the dietary management of a subject having, suspected of having or being at risk of developing gastro-intestinal dysfunction and/or associated morbidities thereto comprising administering to the subject an effective amount of a composition II according to any one of embodiments 1-11 to 73-11 or a nutritional supplement according to any one of embodiments 95-11 to 103-11 or a functional food according to any one of embodiments 95-11 to 103-11.
  • the method according to any one of embodiments 104-11 to 108-11, wherein the application rate of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 0.1 to 10.0 g/day, preferably from 1.0 to 9.0 g/day, more preferably from 1 .2 to 9.0 g/day, in particular from 2.0 to 8.0 g/day, especially from 2.5 to 6.0 g/day. -11.
  • C3-C4-alkane carboxylic acid or derivative(s) thereof is a mixture of propionic acid or a derivative thereof and butyric acid or a derivative thereof and the application rate of propionic acid and/or a derivative thereof is from 0.1 to 4.0 g/day and the application rate of butyric acid and/or a derivative thereof is from 0.1 to 6.0 g/day, preferably the application rate of propionic acid and/or a derivative thereof is from 0.5 to 4.0 g/day, and the application rate of butyric acid and/or a derivative thereof is from 0.5 to 5.0 g/day, more preferably the application rate of propionic acid and/or a derivative thereof is from 1 .0 to 3.0 g/day, and the application rate of butyric acid and/or a derivative thereof is from 1.5 to 4.0 g/day.
  • a method to treat a subject having gastro-intestinal dysfunction and/or associated morbidities thereto by administering to the subject a) an effective amount of a composition II according to any one of embodiments 1-11 to 73-11, a composition II for use as a medicament according to embodiment 74-11, a composition II for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto according to any one of embodiments 75-11 to 84-11, a nutritional supplement or a functional food according to any one of embodiments 95-11 to 104-11, or with one of components A, B and C, or with two of components A, B and C as described in any one of embodiments 1-11 to 73-11, and b) an effective amount of at least one pharmaceutical suitable to treat said gastro-intestinal dysfunction and/or associated morbidities thereto, wherein the application rate of the at least one pharmaceutical suitable to treat said gastrointestinal dysfunction and/or associated morbidities thereto is reduced compared to a treatment with the at least one pharmaceutical alone.
  • infections antibiotics
  • prednisone prednisone
  • immunomodulators azathioprine, methotrexate, infliximab, adalimumab, certolizumab, vedolizumab, ustekinumab, natalizumab.
  • a composition comprising a) i) at least one HMO, and/or ii) at least one carotenoid, and/or iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof; and b) an effective amount of at least one pharmaceutical, especially being suitable for the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto, in particular for use as a medicament, especially for use in the treatment of the gastrointestinal dysfunction and/or associated morbidities thereto.
  • a composition comprising a) i) as component A 2’-FL, and/or ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta-carotene and/or lutein, especially beta-carotene, and/or iii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and/or sodium butyrate; and b) an antibiotic (like cefaclor, cefuroxime, penicillin, amoxicillin and the like), an antiinflammatory drug (like prednisone and the like), and/or an immunomodulator (like azathioprine, methotrexate, infliximab, adalimumab, certolizumab, vedolizumab, ustekinumab, natalizumab and the like) in a pharmaceutical effective amount, in particular for use as a medicament
  • composition II as defined in any one of embodiments 1-11 to 73-11 as a nutritional supplement for the dietary management of gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the subject is a human, preferably in the age of 12 years or older, more preferably 18 years or older, even more preferably 35 years or older, in particular 50 years or older even more in particular 60 years or older.
  • a kit for the pharmaceutical use or dietary management use comprising a first component A being at least one HMO, preferably as described in any one of embodiments 1-11 to 73-11, and a second component B being at least one carotenoid, preferably as described in any of embodiments 1-11 to 73-11, and optionally a third component C being at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, preferably as described in any embodiments 1-11 to 73- II for the treatment or prevention or dietary management use of gastro-intestinal dysfunction and/or associated morbidities thereto.
  • kits according to embodiment 124-11 wherein the kit is for the pharmaceutical use forthe treatment or prevention of gastro-intestinal dysfunction or dietary management use of gastrointestinal dysfunction.
  • kits according to embodiment 124-11 wherein the kit is for the pharmaceutical use forthe treatment or prevention of morbidities associated to gastro-intestinal dysfunction or dietary management use of morbidities associated to gastro-intestinal dysfunction.
  • a kit for the pharmaceutical use or dietary management use comprising a) a first component A being at least one HMO, preferably as described in any one of embodiments 1-11 to 73-11, and/or a second component C being at least one carotenoid as described in any embodiments 1-11 to 73-11 and/or a third component B being at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, preferably as described in any of embodiments 1-11 to 73-11; and b) an effective amount of at least one pharmaceutical, especially being suitable for the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto, for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto.
  • kits forthe pharmaceutical use or dietary management use according to embodiment 127-11, wherein the at least one pharmaceutical is an antibiotic (like cefaclor, cefuroxime, penicillin, amoxicillin and the like), an anti-inflammatory drug (like prednisone and the like), and/or an immunomodulator (like azathioprine, methotrexate, infliximab, adalimumab, certolizumab, vedolizumab, ustekinumab, natalizumab and the like), in particular in a pharmaceutical effective amount.
  • an antibiotic like cefaclor, cefuroxime, penicillin, amoxicillin and the like
  • an anti-inflammatory drug like prednisone and the like
  • an immunomodulator like azathioprine, methotrexate, infliximab, adalimumab, certolizumab, vedolizumab, ustekinumab, natalizumab and the like
  • C3-C4-alkane carboxylic acids or derivatives thereof can be combined with at least one carotenoid, and optionally with HMOs. Such compositions provide beneficial effects as described herein.
  • composition III comprises i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one carotenoid, and optionally iii) at least one HMO.
  • HMO refers to human milk oligosaccharide(s). These carbohydrates are resistant to enzymatic hydrolysis by digestive enzymes (e.g. pancreatic and/or brush border).
  • digestive enzymes e.g. pancreatic and/or brush border.
  • HMOs are found in the human breast milk. Each individual HMO is based on a combination of glucose, galactose, sialic acid (N-acetylneuraminic acid), fucose and/or N-acetylglucosamine with many and varied linkages between them. So far over 130 such structures have been identified in human milk.
  • the HMOs can be acidic (e.g. charged sialic acid containing oligosaccharide) or neutral (e.g. fucosylated oligosaccharide).
  • the HMO is selected from the group of fucosylated oligosaccharides, N-acetylated oligosaccharides and sialylated oligosaccharides.
  • the HMO is a "fucosylated oligosaccharide". These are HMOs having a fucose residue. It has a neutral nature. Some examples are 2'-FL (2'-fucosyllactose), 3-FL (3-fucosyllactose), difucosyllactose, lacto-N-fucopentaose (e.g.
  • lacto-N- fucopentaose I lacto- N-fucopentaose II, lacto-N-fucopentaose III, lacto-N-fucopentaose V)
  • lacto-N-fucohexaose lacto-N- difucohexaose I, fucosyllacto-N-hexaose, fucosyllacto- N-neohexaose, difucosyllacto-N-hexaose I, difucosyllacto-N-neohexaose II and any combination thereof.
  • the fucosylated oligosaccharide is selected from the group comprising 2’-FL, 3-FL and difucosyllactose (e.g. 2’,2”-DiFL and/or 3, 2’-DiFL).
  • the fucosylated oligosaccharide is 2’-FL.
  • the HMO is a ”N-acetylated oligosaccharide.
  • the term ”N-acetylated oligosaccharide(s)” encompasses both "N-acetyl-lactosamine” and "oligosaccharide(s) containing N-acetyl-lactosamine". They are neutral oligosaccharides having an N-acetyl-lactosamine residue. Suitable examples are LNT (lacto-N-tetraose), para-lacto-N- neohexaose (para-LNnH), LNnT (lacto-N-neotetraose) or any combination thereof.
  • N-acetylated oligosaccharide is selected from the group of LNT and LNnT.
  • the HMO is a ’’sialylated oligosaccharide.
  • the term ’’sialylated oligosaccharide encompasses an oligosaccharide having a sialic acid residue. It has an acidic nature. Some examples are 3’-SL (3'-sialyllactose) and 6’-SL (6'-sialyllactose). In a preferred embodiment the sialylated oligosaccharide is 6’-SL.
  • the HMO is selected from the group comprising 2’-FL, 3-FL, difucosyllactose (e.g. 2’,2”-DiFL and/or 3, 2’-DiFL), LNT, LNnT, 3’-SL and 6’-SL and/or any combination thereof.
  • the HMO is selected from the group comprising 2’-FL, difucosyllactose (e.g. 2’,2”-DiFL and/or 3,2’-DiFL), LNT, LNnT and 6’-SL and/or any combination thereof.
  • the HMO is selected from the group comprising 2’-FL, LNT, LNnT and 6'-SL and/or any combination thereof.
  • C3-C4-alkane carboxylic acid or derivative thereof encompasses propionic acid, n-butyric acid and iso-butyric acid (2-methyl propionic acid) as well as derivatives thereof and/or any mixture thereof.
  • Suitable derivatives are salts, esters and amides, in particular physiologically acceptable ones.
  • physiologically acceptable salts are alkali salts, like sodium or potassium salts, or alkaline-earth salts, like magnesium or calcium salts, or choline salts.
  • physiologically acceptable salts are alkali salts, in particular sodium salts or potassium salts, especially sodium salts.
  • physiologically acceptable esters are those derived from C1-C6 alcohols, in particular those derived from monohydric C1-C6 alcohols, e.g. those derived from methanol or ethanol, or dihydric C1-C6 alcohols, like those derived from 1 ,2-ethandiol, or C1-C4 alkoxy substituted monohydric alcohols, like those derived from 2-methoxyethanol, 2-ethoxyethanol or 2-butoxyethanol.
  • Other examples for physiologically acceptable esters are glycerides, like mono-, di-, or triglycerides, in particular mono- or diglycerides.
  • the physiologically acceptable esters are those derived from monohydric C1-C6 alcohols, e.g. those derived from methanol or ethanol, or mono- or diglycerides.
  • physiologically acceptable amides are those derived from mono- or di-C1-C6-alkyl amines.
  • the C3-C4 alkane carboxylic acid is provided as physiologically acceptable derivative thereof; in particular the derivative is a physiologically acceptable salt, e.g. a sodium salt or potassium salt, or a mixture thereof, or a physiologically acceptable ester, e.g. said ester is derived from C1-C6 alcohols, in particular a mono-or a dihydric C1-C6 alcohol, or said ester is a mono- or diglyceride, or a mixture thereof.
  • a physiologically acceptable salt e.g. a sodium salt or potassium salt, or a mixture thereof
  • a physiologically acceptable ester e.g. said ester is derived from C1-C6 alcohols, in particular a mono-or a dihydric C1-C6 alcohol, or said ester is a mono- or diglyceride, or a mixture thereof.
  • the C3-C4-alkane carboxylic acid or derivative thereof is sodium propionate or potassium propionate or sodium butyrate or potassium butyrate or a mixture thereof. Especially, it is sodium propionate or sodium butyrate or a mixture thereof.
  • the C3-C4-alkane carboxylic acid or derivative thereof is propionic acid or a derivative thereof, in particular it is a physiologically acceptable salt of propionic acid, especially it is sodium propionate or potassium propionate, or a physiologically acceptable ester of propionic acid, especially methyl propionate or ethyl propionate or propionic acid monoglyceride or propionic acid diglyceride, particularly ethyl propionate or propionic acid monoglyceride.
  • the C3-C4-alkane carboxylic acid or derivative thereof is sodium propionate or potassium propionate.
  • the C3-C4-alkane carboxylic acid or derivative thereof is butyric acid or a derivative thereof, in particular it is a physiologically acceptable salt of butyric acid, especially it is sodium butyrate or potassium butyrate, or a physiologically acceptable ester of butyric acid, especially methyl butyrate or ethyl butyrate or butyric acid monoglyceride or butyric acid diglyceride, particularly ethyl butyrate or butyric acid monoglyceride.
  • the C3-C4- alkane carboxylic acid or derivative thereof is sodium butyrate or potassium butyrate.
  • the at least one C3-C4-alkane carboxylic acid or derivative thereof is a mixture of propionic acid and butyric acid or derivatives thereof, in particular it is a mixture of physiologically acceptable salts of propionic acid and butyric acid, especially it is a mixture of sodium propionate and sodium butyrate or a mixture of potassium propionate and potassium butyrate, or a mixture of physiologically acceptable esters of propionic acid and butyric acid, especially a mixture of methyl propionate and methyl butyrate, or a mixture of ethyl propionate and ethyl butyrate, or a mixture of propionic acid monoglyceride and butyric acid monoglyceride, or a mixture of propionic acid diglyceride and butyric acid diglyceride, particularly a mixture of ethyl propionate and ethyl butyrate or a mixture of propionic acid monoglyceride and butyric acid monoglyceride.
  • the term “carotenoid” relates to at least one carotenoid selected from the group consisting of astaxanthin, alpha-carotene, beta-carotene, beta-cryptoxanthin, lycopene, lutein, meso-zeaxanthin and zeaxanthin.
  • the carotenoid is at least one selected from the group consisting of beta-carotene, lycopene, lutein and meso-zeaxanthin or mixtures thereof, particularly it is beta-carotene and/or lutein, especially beta-carotene.
  • composition III comprises i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one carotenoid.
  • composition III comprises i) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene.
  • composition III does not comprise one or more HMO.
  • composition III comprises i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one carotenoid, and iii) at least one HMO.
  • composition III comprises i) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, and iii) as component A 2’-FL.
  • the composition III comprises i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one carotenoid, and optionally iii) at least one HMO, wherein the ratio of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof (component B) and the at least one carotenoid (component C) is from is from 1 : 1 to 200000:1 .
  • the composition III comprises as at least one C3-C4- alkane carboxylic acid or derivative(s) thereof a mixture of propionic acid or a derivative thereof and butyric acid or a derivative thereof, in a ratio of from 100 : 1 to 1 : 100, preferably from 20:1 to 1 : 20, more preferably from 10:1 to 1 :15, even more preferably from 2:1 to 1 :8.
  • At least one C3-C4-alkane carboxylic acid or derivative(s) thereof and the at least one carotenoid (component C) are present in synergistic amounts.
  • composition III does not comprise one or more HMO.
  • the composition III comprises i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one carotenoid, and iii) at least one HMO, wherein the ratio of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof (component B) and the at least one carotenoid (component C) is from is from 1 : 1 to 200000:1 , and/or wherein the ratio of the at least one HMO (component A) and the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof (component B) is from 100 :1 to 1 : 100, preferably from 20:1 to 1 :20, more preferably 10:1 to 1 :10, even more preferably from 3: 1 to 1 :3, in particular2:1 to 1 :2, and/or wherein the ratio of the at least one HMO (component A) and the at least one
  • said composition III comprises as at least one C3- C4-alkane carboxylic acid or derivative(s) thereof a mixture of propionic acid or a derivative thereof and butyric acid or a derivative thereof, in a ratio of from 100 : 1 to 1 : 100, preferably from 20:1 to 1 : 20, more preferably from 10:1 to 1 :15, even more preferably from 2:1 to 1 :8.
  • the at the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof and the at least one carotenoid are present in synergistic amounts.
  • the at least one HMO and the at least one the carotenoid are present in synergistic amounts.
  • the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof and the at least one HMO are present in synergistic amounts.
  • the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, the at least one carotenoid and the at least one HMO are present in synergistic amounts.
  • the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof and the at least one carotenoid, and optionally the at least one HMO is from 1 to 100 wt% of the total composition III, preferably from 10 to 100 wt%.
  • the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 10 to 99,99999 wt% of the total composition III, preferably from 15 to 99,9999 wt%, more preferably from 20 to 99,999 wt%, even more preferably from 25 to 99,999 wt%. In yet another embodiment the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 10 to 50 wt% of the total composition III, preferably from 15 to 45 wt%, more preferably from 20 to 35 wt%.
  • the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 50 to 90 wt% of the total composition III, preferably from 55 to 80 wt%, more preferably from 60 to 75 wt%.
  • the total amount of the at least one carotenoid is from 0.0005 to 50 wt% of the total composition I, preferably from 0.005 to 5.0 wt%, more preferably from 0.05 to 0.5 wt%, even more preferably from 0.5 to 4 wt%, even more preferably from 0.1 to 4 wt%, even more preferably from 0.1 to 3 wt%, even more preferably from 0.1 to 2 wt%, even more preferably from 0.1 to 1 wt%.
  • the total amount of the at least one HMO is from 10 to 90 wt% of the total composition III, preferably from 20 to 80 wt%, more preferably from 30 to 70 wt%, even more preferably from 40 to 60 wt%. In yet another embodiment the total amount of the at least one HMO is from 5 to 50 wt% of the total composition III, preferably from 8 to 40 wt%, more preferably from 10 to 35 wt%, even more preferably from 15 to 30 wt%. In yet another embodiment the total amount of the at least one HMO is from 50 to 95 wt% of the total composition III, preferably from 55 to 80 wt%, more preferably from 60 to 75 wt%.
  • the composition III can further comprise one or more vitamins or related compounds thereto.
  • vitamins and related compounds thereto include vitamin A (e.g. retinol, retinyl acetate, retinyl palmitate, retinyl stearate, retinyl esters with other long-chain unsaturated fatty acids, retinal, retinoic acid and the like), vitamin B1 (e.g. thiamine, thiamine pyrophosphate, TPP, thiamine triphosphate, TTP, thiamine hydrochloride, thiamine mononitrate and the like), vitamin B2 (e.g.
  • vitamin B3 e.g. nicotinic acid, nicotinamide, nicotinamide adenine dinucleotide (NAD), nicotinic acid mononucleotide (NicMN), pyridine-3-carboxylic acid and the like, as well as the vitamin B3-precursor tryptophan
  • pantothenic acid e.g. pantothenate, panthenol and the like
  • vitamin B6 e.g.
  • pyridoxine pyridoxal, pyridoxamine, pyridoxine hydrochloride and the like
  • biotin folic acid (e.g. folate, folacin, pteroylglutamic acid and the like)
  • vitamin B12 e.g. cobalamin, methylcobalamin. deoxyadenosyl- cobalamin, cyanocobalamin, hydroxycobalamin, adenosylcobalamin and the like
  • vitamin E e.g.
  • alpha-, beta-, gamma- and/or delta-tocopherol alpha-, beta-, gamma- and/or delta-tocopherol acetate, alpha-, beta-, gamma- and/or delta-tocopherol succinate, alpha-, beta-, gamma- and/or delta-tocopherol nicotinate, alpha-, beta-, gamma- and/or delta tocotrienol and the like), vitamin K (e.g. vitamin K2, vitamin K1 , phylloquinone, naphthoquinone, vitamin K3, menadione, and the like ), vitamin C (ascorbic acid), vitamin D (e.g. calciferol, cholecalciferol, 1 ,25-dihydroxyvitamin D, ergocaliferol and the like), and the like and/or mixtures thereof.
  • vitamin K e.g. vitamin K2, vitamin K1 , phylloquinone,
  • composition III does not comprise one or more HMO.
  • composition III does comprise one or more HMO.
  • composition III does not comprise one or more vitamins or related compounds thereto.
  • composition III does comprise one or more vitamins or related compounds thereto.
  • the composition III can further comprise one or more medium-chain fatty acids.
  • These medium-chain fatty acids may be provided as free fatty acids, as glycerides (e.g. as monoglycerides, diglycerides or triglycerides and/or as mixtures thereof), as phospholipids, as alkyl esters and/or as mixtures thereof, preferably as glycerides, more preferably as triglycerides or alkyl esters.
  • Examples of medium-chain fatty acids include caproic acid, caprylic acid, capric acid, lauric acid and the like and /or mixtures thereof. The presence and amounts of specific medium chain fatty acids will vary depending on the intended use.
  • composition III does not comprise one or more HMO.
  • composition III does comprise one or more HMO.
  • composition III does not comprise one or more medium-chain fatty acids.
  • composition III can further comprise one or more long-chain fatty acids.
  • long-chain fatty acids may be provided as free fatty acids, as glycerides (e.g. as monoglycerides, diglycerides or triglycerides and/or as mixtures thereof), as phospholipids, as alkyl esters and/or as mixtures thereof, preferably as glycerides, more preferably as triglycerides or as alkyl esters.
  • long chain fatty acids include saturated long chain fatty acids (e.g.
  • linoleic acid linoelaidic acid, alpha-linolenic acid, arachidonic acid, eicosapentaenoic acid, docosapentenoic acid, docosahexaenoic acid and the like and/or mixtures thereof) and/or mixtures thereof.
  • These long chain fatty acids are comprised for example in vegetable oils, single cell oils and marine oils, e.g. fish oil, krill oil and the like.
  • composition III does not comprise one or more HMO.
  • composition III does comprise one or more HMO.
  • composition III does not comprise one or more long-chain fatty acids.
  • composition III can further comprise one or more prebiotics.
  • prebiotics include water-insoluble fibers (e.g. lignin, cellulose, hemi- cellulose, resistant starch, xanthum gum and the like and/or mixtures thereof), water-soluble fibers (e.g.
  • arabinoxylan arabinoxylan, inulin, pectin, alginic acid and derivatives thereof, agar, carrageen, raffinose, xylose, polydextrose, lactulose , xylooligosaccharides, fructooligosaccharides, galactooligosaccharides, isomalto-oligosaccharides and the like and/or mixtures thereof) and the like and/or mixtures thereof.
  • composition III does not comprise one or more HMO.
  • composition III does comprise one or more HMO.
  • composition III does not comprise one or more prebiotics.
  • composition III can further comprise one or more probiotics.
  • probiotics optionally present in the composition III of the present invention include microorganisms or parts thereof of the family Lactobacillaceae, e.g. of the genus Lactobacillus (e.g. the species lactobacillus acidophilus, lactobacillus alimentarius, lactobacillus casei, lactobacillus delbrueckii (like lactobacillus delbrueckii spp. bulgaricus, lactobacillus delbrueckii spp. delbrueckii, lactobacillus delbrueckii spp.
  • the family Lactobacillaceae e.g. of the genus Lactobacillus (e.g. the species lactobacillus acidophilus, lactobacillus alimentarius, lactobacillus casei, lactobacillus delbrueckii (like lactobacillus delbrueckii spp. bulg
  • lactis lactobacillus helveticus, lactobacillus plantarum, lactobacillus reuteri, lactobacillus rhamnosus, lactobacillus salivarius and the like), of the genus Bifidobacterium (e.g. the species bifidobacterium animalis, bifidobacterium bifidum, bifidobacterium breve, bifidobacterium infantis, bifidobacterium lactis, bifidobacterium longum and the like), of the genus Pediococcus (e.g.
  • Lactococcus e.g. the species lactococcus lactis (like lactococcus latis spp. cremoris, lactococcus lactis spp. lactic and the like
  • composition III does not comprise one or more HMO.
  • composition III does comprise one or more HMO.
  • composition III does not comprise one or more probiotics.
  • composition III can further comprise one or more phenolic compounds.
  • phenolic compounds include monophenols (e.g. apiole, carnosol, carvacrol, dillapiole, rosemarinol and the like), flavonoids (e.g.
  • quercetin kaempferol, myricetin, fisetin, rutin, isorhamnetin, hesperidin, naringenin, silybin, eriodyctiol, acacetin, apigenin, chrysin, diosmetin, tangeritin, luteolin, catechins like epigallocatechin gallate, theaflavin, thearubigins, proanthocyanidins, pelargonidin, peonidin, cyanidin, delphinidin, malvidin, petunidin and the like), isoflavonoids (e.g.
  • daidzein genistein, glycitein and the like
  • aurones chalconoids
  • flavonolignans lignans
  • phytoestrogens stilbenoids (e.g. resveratrol, pterostilbene, piceatannol and the like)
  • curcuminoids e.g. curcumin and the like
  • tannins aromatic acids (e.g. salicylic acid, vanillic acid, gallic acid, ellagic acid, tannic acid, caffeic acid, chlorogenic acid, cinnamic acid, ferulic acid, coumarin and the like), phenylethanoids (e.g. tyrosol, hydroxytyrosol, oleocanthal, oleuropein and the like ), capsaicin, gingerol, alkylresorcinol and the like and/or mixtures thereof.
  • aromatic acids e.g. salicylic acid, vanillic acid, gallic acid
  • composition III does not comprise one or more HMO.
  • composition III does comprise one or more HMO.
  • composition III does not comprise one or more phenolic compounds.
  • composition III can further comprise one or more herbals, e.g. known from Chinese diets, Indian diets, Mediterranean diets and the like. These herbals can be provided as powders obtained from the plant and/or fungus or parts thereof or as extracts thereof.
  • herbals e.g. known from Chinese diets, Indian diets, Mediterranean diets and the like. These herbals can be provided as powders obtained from the plant and/or fungus or parts thereof or as extracts thereof.
  • herbals known from Chinese diets include extracts or powders of hawthorn fruit, wolfberry, spatholobus stem, caterpillar fungus, cloud mushroom, crysanthemum, honeysuckle flower, mulberry leaf, glossy privet fruit, malaytea scurfpea fruit, cherokee rose fruit, palmleaf raspberry fruit, Chinese magnoliavine fruit, reishi mushroom, ephedra, epimedium, Angelica root, Astragalus root, rhubarb, licorice, morinda root, notoginseng, white peony root, American ginseng, fleeceflower root, kudzu root, rehmannia root, salvia root, Chinese yam, wild buckwheat rhizome, tall gastrodia tuber, golden root, Cassia seed, Coix seed, Dodder seed and the like and/or mixtures thereof.
  • herbals known from Indian diets include extracts or powders of Amalaki (Indian gooseberry), Haritaki (chebulic myrobalan), Bibhitaki (beleric), Haldi (turmeric), Tulsi (holy basil), Shigru (moringa), Twak (cinnamon), Yashtimadhu (licorice root), Dhanyaka (coriander), Ashwagandha (winter cherry), Kumkuma (saffron), Manjistha (Indian madder), Brahmi (bacopa), Neem (margosa), Ajwain (Bishop’s weed), Elaichi (cardamom), Shikakai (Acacia concinna), Shatavari (wild asparagus), Jeera (cumin), Guduchi (tinospora) and the like and/or mixtures thereof.
  • Examples for herbals known from Mediterranean diets include extracts or powders of rosemary, basil, parsley, saffron, thyme, oregano, sage, cilantro, lemon, orange, grape, grapeseed, fig, blueberry, raspberry, strawberry, cherry, fennel, sesame seeds, pine seeds, garlic, onion, ginger root, pepper, chili and the like, olive oil and/or mixtures thereof.
  • composition III does not comprise one or more HMO.
  • composition III does comprise one or more HMO.
  • composition III does not comprise one or more herbals.
  • composition III can further comprise one or more minerals.
  • minerals include such ones comprising calcium, phosphorous, iodine, iron, magnesium, copper, zinc, manganese, chlorine, potassium, sodium, selenium, chromium, molybdenum and the like and/or mixtures thereof. Minerals are usually added in salt form.
  • composition III does not comprise one or more HMO.
  • composition III does comprise one or more HMO.
  • composition III does not comprise one or more minerals. In a further embodiment of the present invention the composition III does not comprise a mineral comprising iron.
  • composition III does not comprise one or more antibodies.
  • composition III does not comprise a sorbate salt, in particular does not comprise potassium sorbate.
  • composition III does not comprise glutamine. In another embodiment of the present invention the composition III does not comprise one or more elements selected from the group of prebotics, probiotics, sorbate salts, in particular potassium sorbate, and glutamine.
  • compositions III of the present invention can be prepared by mixing the at least one carotenoid, and the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally the at least one HMO, and optionally further components e.g. vitamins and related compounds thereto, carotenoids, medium chain fatty acids, long chain fatty acids, prebiotics, probiotics, phenolic compounds, herbals, minerals and the like and/or mixtures thereof, as known in the art.
  • the composition III does not comprise more than 65 wt% water, in particular more than 80 wt% water.
  • composition III which comprises i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, ii) at least one carotenoid, and optionally iii) at least one HMO, for use as a medicament, preferably as a medicament for mammals, birds, crustaceans and/or fishes, in particular as a medicament for mammals.
  • the term ’’mammals encompasses humans and nonhuman mammals.
  • non-human mammals are livestock, e.g. sheep, goats, pigs, cattles, horses, camels, llamas and the like, and pets, e.g. cats, dogs and the like.
  • composition III is for use as a medicament for humans.
  • composition III is for use as a medicament for livestock and/or pets.
  • composition III is for use as a medicament for birds, crustaceans, e.g. poultry (like chickens, ducks, geese, turkeys and the like) and ornamental birds (like canaries and the like).
  • crustaceans e.g. poultry (like chickens, ducks, geese, turkeys and the like) and ornamental birds (like canaries and the like).
  • composition III is for use as a medicament for fishes, e.g. fishes used for consumption (like salmon, tuna, sardines, cod, trout, and the like) and ornamental fishes (like kois and the like).
  • fishes e.g. fishes used for consumption (like salmon, tuna, sardines, cod, trout, and the like) and ornamental fishes (like kois and the like).
  • composition III is for use as a medicament for crustaceans, e.g. crustaceans used for consumption (like crabs, lobsters, crayfish, shrimps, prawns, krill and the like) and ornamental crustaceans (like crabs, lobsters, crayfish, shrimps, prawns, krill and the like).
  • crustaceans used for consumption (like crabs, lobsters, crayfish, shrimps, prawns, krill and the like) and ornamental crustaceans (like crabs, lobsters, crayfish, shrimps, prawns, krill and the like).
  • compositions III of the present invention for use as a medicament can be administered orally, enterally or parenterally, preferably orally.
  • composition III for use as a medicament is an orally administrable composition.
  • the composition III comprises i) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, and optionally iii) as component A 2’-FL, for use as a medicament, preferably as a medicament for humans.
  • composition III shall be applicable for the compositions III for use as a medicament and the specific embodiments thereto.
  • the present invention provides a composition III which comprises i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one carotenoid, and optionally iii) at least one HMO, for the use in the treatment and/or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto, preferably of mammals, more preferably of humans.
  • the term ’’treatment” in the context of gastro-intestinal dysfunction and/or associated morbidities thereto means using an effective therapy or management to alleviate, reduce or cure the condition and/or disease (gastro-intestinal dysfunction and/or associated morbidities thereto) and/or symptoms thereof, as the case may be, in addition it also includes the stabilization of the condition and/or disease, as the case may be, in order not to worsen in the course of the respective condition and/or disease.
  • treatment is understood as using an effective therapy or management to stabilize, alleviate or reduce the condition and/or disease and/or symptoms thereof, as the case may be.
  • gastro-intestinal dysfunction and/or associated morbidities thereto means an effective therapy or management so that the condition and/or disease (gastro-intestinal dysfunction and/or associated morbidities thereto) does not de novo develop, manifest and/or symptoms thereof do not occur.
  • composition III is for use in the treatment of gastro intestinal dysfunction and/or associated morbidities thereto.
  • composition III is for use in the prevention of gastro-intestinal dysfunction and/or associated morbidities thereto.
  • the term ’’gastro-intestinal dysfunction refers to a condition and/or disease, as the case may be, which is characterized by an abnormal function of the gastro intestinal system of a respective subject.
  • a person with gastro-intestinal dysfunction has a disturbance of digestion and absorption processes; disturbance of motility; disturbance of barrier function and immune system; disturbance of formation and deposition of feces.
  • composition III is for use in the treatment or prevention of gastro-intestinal dysfunction of a human.
  • associated morbidities as well as the term ’’morbidities associated to” mean one or more conditions and/or diseases which are co-occurring to the primary condition or disease (gastro-intestinal dysfunction), or which are occurring later in the life of the subject who had earlier in his or her life said primary condition and/or disease (gastro intestinal dysfunction).
  • composition III is for use in the treatment or prevention of an associated morbidity, e.g. an associated morbidity of the esophagus, which includes functional chest pain, functional heartburn, reflux hypersensitivity, globus, functional dysphagia, esophagitis, esophageal ulceration, esophageal cancer etc., an associated morbidity of the stomach, which includes functional dyspepsia, belching disorders, nausea, vomiting, rumination syndrome, dyspepsia, malnutrition, pernicious anemia, gastritis, gastroenteritis, diarrhea, Crohn’s disease, gastric stenosis, gastric ulcers, gastric cancer etc., an associated morbidity of the small intestine, which includes maldigestion, malnutrition, enteritis, enterocolitis, necrotizing enterocolitis diarrhea, constipation, Coeliac disease, tropical sprue, inflammatory bowel disease (IBD) which includes Crohn’s disease,
  • composition III is for use in the treatment or prevention of an associated morbidity of the esophagus, in particular of a human subject having gastro-intestinal dysfunction.
  • composition III is for use in the treatment or prevention of functional chest pain, functional heartburn, reflux hypersensitivity, globus, functional dysphagia, esophagitis, esophageal ulceration, esophageal cancer, in particular of a human subject having gastro-intestinal dysfunction.
  • composition III is for use in the treatment or prevention of an associated morbidity of the stomach, in particular of a human subject having gastro intestinal dysfunction.
  • composition III is for use in the treatment or prevention of functional dyspepsia, belching disorders, nausea, vomiting, rumination syndrome, dyspepsia, malnutrition, pernicious anemia, gastritis, gastroenteritis, diarrhea, Crohn’s disease, gastric stenosis, gastric ulcers, gastric cancer, in particular of a human subject having gastro intestinal dysfunction.
  • composition III is for use in the treatment or prevention of an associated morbidity of the small intestine, in particular of a human subject having gastro-intestinal dysfunction.
  • composition III is for use in the treatment or prevention of maldigestion, malnutrition, enteritis, enterocolitis, necrotizing enterocolitis diarrhea, constipation, Coeliac disease, tropical sprue, inflammatory bowel disease (IBD) which includes Crohn’s disease, ulcerative colitis and other inflammatory diseases, vitamin deficiency, mineral deficiency, trace element deficiency, fatty acid deficiency, amino acid deficiency, intestinal ulcers, intestinal cancer, in particular of a human subject having gastro-intestinal dysfunction.
  • IBD inflammatory bowel disease
  • composition III is for use in the treatment or prevention of an associated morbidity of the large intestine, in particular of a human subject having gastro-intestinal dysfunction.
  • composition III is for use in the treatment or prevention of diverticulitis, colitis, pseudomembranous colitis, diarrhea, constipation, irritable bowel syndrome (IBS), inflammatory bowel disease which includes Crohn’s disease, ulcerative colitis and other inflammatory diseases, colo-rectal ulcers, colo-rectal cancer, in particular of a human subject having gastro-intestinal dysfunction.
  • IBS irritable bowel syndrome
  • composition III for use in the treatment or prevention of gastro-intestinal dysfunction is an orally administrable composition, in particular for a human subject.
  • composition III for use in the treatment or prevention of morbidities associated to gastro-intestinal dysfunction is an orally administrable composition, in particular for a human subject.
  • the composition III comprises i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one carotenoid, and for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto, in particular of a mammal, especially of gastro-intestinal dysfunction of a human or especially of morbidities associated to gastro-intestinal dysfunction.
  • the composition III comprises i) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto of a mammal, in particular of gastro-intestinal dysfunction of a human, or in particular of morbidities associated to gastro-intestinal dysfunction of a human.
  • composition III for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto, in particular of a mammal, especially of gastro-intestinal dysfunction of a human or especially of morbidities associated to gastro-intestinal dysfunction of a human does not comprise one or more HMO.
  • the composition III comprises i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one carotenoid, and iii) at least one HMO, and for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto of a mammal, in particular of gastro-intestinal dysfunction of a human, or in particular of morbidities associated to gastro-intestinal dysfunction of a human.
  • the composition III comprises i) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and ii) as component C beta-carotene, lycopene, lutein and/or meso-zeaxanthin, preferably beta- carotene and/or lutein, especially beta-carotene, and iii) as component A 2’-FL, for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto of a mammal, in particular of gastro-intestinal dysfunction of a human, or in particular of morbidities associated to gastro-intestinal dysfunction of a human.
  • composition III shall be applicable for the compositions III for use in the treatment or prevention of gastro-intestinal dysfunction and/or associated morbidities thereto and the specific embodiments thereto.
  • the present invention provides a method to treat a subject having a disease, in particular gastro-intestinal dysfunction and/or associated morbidities thereto, or to prevent a subject being suspected of having or being at risk of developing a disease, in particular gastro-intestinal dysfunction and/or associated morbidities thereto, by administering to the subject an effective amount of the composition III which comprises i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one carotenoid, and optionally iii) at least one HMO.
  • the composition III which comprises i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one carotenoid, and optionally iii) at least one HMO.
  • said method is for treating a subject having gastro-intestinal dysfunction, in particular a human, or preventing a subject being suspected of having or being at risk of developing gastro-intestinal dysfunction, in particular a human.
  • said method is for treating a subject having morbidities associated to gastro-intestinal dysfunction, in particular a human, or preventing a subject being suspected of having or being at risk of developing morbidities associated to gastro-intestinal dysfunction, in particular a human.
  • said human subject is in the age of 12 years or older, preferably 18 years or older, more preferably 35 years or older, in particular 50 years or older, even more particular 60 years or older. It is understood that in this method the composition III can be administered, preferably orally, or that any of the “at least one carotenoid ” and the “at least one C3-C4-alkane carboxylic acid or derivative(s) thereof’ and optional the “at least one HMO” and optional further components can be administered separately, preferably orally.
  • composition III comprises as the at least one carotenoid two or more carotenoids these can be administered separately, preferably orally, and in case composition III comprises as the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof two or more C3-C4-alkane carboxylic acid or derivative(s) thereof these can be administered separately, preferably orally, and in case composition III comprises as the at least one HMO two or more HMOs these can be administered separately, preferably orally.

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Abstract

La présente invention concerne des compositions et des procédés de traitement et/ou de prévention d'un dysfonctionnement gastro-intestinal et/ou de morbidités associées à celui-ci d'un sujet. En particulier, la présente invention concerne des compositions comprenant au moins un oligosaccharide de lait humain (HMO) et au moins un acide carboxylique d'alcane en C3-C4 et éventuellement au moins un caroténoïde.
PCT/EP2021/058185 2020-03-27 2021-03-29 Composition pour le traitement d'un dysfonctionnement gastro-intestinal et/ou de morbidités associées WO2021191469A1 (fr)

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