# US 11,896,604 B2 · Composition comprising HMSs/HMOs and use thereof > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,896,604 B2 - Document ID: US11896604B2 - Status: Granted - Kind: B2 - Application number: 17/353,730 - Filed: 2021-06-21 - Published: 2021-10-07 - Granted: 2024-02-13 - Earliest claimed: 2014-10-29 - Assignees: Glycom A/S - Applicants: Glycom A/S - Inventors: Bruce McConnell; Emma Elison; Louise Kristine Vigsnæs - Web page: https://patentgrep.com/patent/US11896604B2 ## CPC - A61K 31/702: Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages - A61K 31/7016: Disaccharides, e.g. lactose, lactulose (lactobionic acid A61K31/7032) - A61P 1/12: Antidiarrhoeals - A61K 2300/00: Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00 - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract The application relates to a method for the prophylaxis or treatment of non-infectious diarrhea in a human, the method comprising administering to the human an effective amount of one or more human milk oligosaccharides. ## Claims ### Claim 1 A method comprising: selecting a non-infant human experiencing diarrhea-predominant irritable bowel syndrome (“IBS-D”); selecting a daily dose comprising an effective amount of one or more neutral human milk oligosaccharides (HMOs) selected from the group consisting of 2′-fucosyllactose (2′-FL), 3-fucosyllactose (3-FL), difucosyllactose (DFL), lacto-N-fucopentaose I (LNFP-I), lacto-N-tetraose (LNT), lacto-N-neotetraose (LNnT), and combinations thereof, the amount effective for increasing a relative abundance of Bifidobacterium adolescentis in the gastrointestinal microbiota of the non-infant human; and increasing the relative abundance of Bifidobacterium adolescentis in the gastrointestinal microbiota of the non-infant human and improving stool consistency in the non-infant human by administering to the non-infant human the daily dose of from about 3 g to about 10 g of the one or more HMOs. ### Claim 2 (depends on 1) The method of claim 1, further comprising improving an impaired mucosal barrier in the non-infant human by administering to the non-infant human the daily dose of the one or more HMOs. ### Claim 3 (depends on 1) The method of claim 1, further comprising reducing bowel movement frequency by administering to the non-infant human the daily dose of the one or more HMOs. ### Claim 4 (depends on 1) The method of claim 1, further comprising reducing levels of an inflammatory marker in the non-infant human by administering to the non-infant human the daily dose of the one or more HMOs. ### Claim 5 (depends on 1) The method of claim 1, wherein administering the one or more neutral HMOs comprises administering a mixture of: at least one fucosylated neutral HMO selected from 2′-FL, 3-FL, DFL, and LNFP-I; and at least one non-fucosylated neutral HMO selected from LNT and LNnT. ### Claim 6 (depends on 5) The method of claim 5, wherein the mass ratio of the fucosylated neutral HMOs to the non-fucosylated neutral HMOs in the mixture is from 4:1 to 2:1. ### Claim 7 (depends on 1) The method of claim 1, wherein a lower daily dose of the one or more HMOs during a maintenance period is from about 1 g to about 5 g per day. ### Claim 8 (depends on 1) The method of claim 1, further comprising administering with the selected effective amount of the one or more HMOs, one or more additional HMOs selected from the group consisting of 3′-sialyllactose (3′-SL) and 6′-sialyllactose (6′-SL). ### Claim 9 (depends on 1) The method of claim 1, further comprising reducing levels of Escherichia and Clostridium in the non-infant human by administering to the non-infant human the daily dose of the one or more HMOs. ### Claim 10 A method comprising: selecting a non-infant human experiencing lactose intolerance and one or more gastrointestinal symptoms of lactose intolerance, the gastrointestinal symptoms selected from diarrhea, abdominal pain, cramping, bloating, and flatulence; selecting a daily dose comprising an effective amount of one or more neutral human milk oligosaccharides (HMOs) selected from the group consisting of 2′-fucosyllactose (2′-FL), 3-fucosyllactose (3-FL), difucosyllactose (DFL), lacto-N-fucopentaose I, lacto-N-tetraose (LNT), lacto-N-neotetraose (LNnT), and combinations thereof, the amount effective for increasing a relative abundance of Bifidobacterium adolescentis in the gastrointestinal microbiota of the non-infant human; and increasing the relative abundance of Bifidobacterium adolescentis in the gastrointestinal microbiota of the non-infant human and reducing at least one of the one or more gastrointestinal symptoms of the lactose intolerance by administering to the non-infant human the daily dose of from about 3 g to about 10 g of the one or more HMOs during an initial treatment period. ### Claim 11 (depends on 10) The method of claim 10, further comprising: reintroducing dairy foods into the diet of the non-infant human consumption after the initial treatment period; and reducing the likelihood of the one or more gastrointestinal symptoms of lactose intolerance occurring in the non-infant human upon reintroduction of the dairy foods by administering to the non-infant human the daily dose of the one or more HMOs. ### Claim 12 (depends on 10) The method of claim 10, wherein administering the one or more neutral HMOs comprises administering a mixture of: at least one fucosylated neutral HMO selected from 2′-FL, 3-FL, DFL, and LNFP-I; and at least one non-fucosylated neutral HMO selected from LNT and LNnT. ### Claim 13 (depends on 12) The method of claim 12, wherein the mass ratio of the fucosylated neutral HMOs to the non-fucosylated neutral HMOs in the mixture is from 4:1 to 2:1. ### Claim 14 (depends on 10) The method of claim 10, further comprising administering with the selected effective amount of the one or more HMOs, one or more additional HMOs selected from the group consisting of 3′-sialyllactose (3′-SL) and 6′-sialyllactose (6′-SL). ### Claim 15 A method comprising: selecting a non-infant human commencing an antibiotic therapy; selecting a daily dose comprising an effective amount of one or more neutral human milk oligosaccharides (HMOs) selected from the group consisting of 2′-fucosyllactose (2′-FL), 3-fucosyllactose (3-FL), difucosyllactose (DFL), lacto-N-fucopentaose I, lacto-N-tetraose (LNT), lacto-N-neotetraose (LNnT), and combinations thereof, the amount effective for increasing a relative abundance of Bifidobacterium adolescentis in the gastrointestinal microbiota of the non-infant human; and increasing the relative abundance of Bifidobacterium adolescentis in the gastrointestinal microbiota of the non-infant human and reducing the likelihood of the non-infant human experiencing gastrointestinal dysbiosis, diarrhea, or both, associated with the antibiotic therapy by administering to the non-infant human the daily dose of from about 3 g to about 10 g of the one or more neutral HMOs. ### Claim 16 (depends on 15) The method of claim 15, further comprising reducing levels of Clostridium in the non-infant human by administering to the non-infant human the daily dose of the one or more HMOs. ### Claim 17 (depends on 16) The method of claim 16, further comprising reducing the likelihood of the non-infant human experiencing diarrhea associated with the Clostridium during the antibiotic therapy by administering to the non-infant human the daily dose of the one or more HMOs. ### Claim 18 (depends on 16) The method of claim 16, further comprising reducing the likelihood of the non-infant human experiencing diarrhea associated with the Clostridium by administering to the non-infant human the daily dose of the one or more HMOs during a post antibiotic therapy period of up to four weeks. ### Claim 19 (depends on 15) The method of claim 15, further comprising reducing hydrogen gas production in the gastrointestinal tract of the non-infant human by administering to the non-infant human the daily dose of the one or more HMOs. ### Claim 20 (depends on 15) The method of claim 15, further comprising increasing the beta-galactosidase activity in the gastrointestinal tract of the non-infant human by administering to the non-infant human the daily dose of the one or more HMOs.