# US 11,896,605 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 11,896,605 B2 - Document ID: US11896605B2 - Status: Granted - Kind: B2 - Application number: 17/353,749 - Filed: 2021-06-21 - Published: 2021-12-16 - Granted: 2024-02-13 - Earliest claimed: 2014-10-29 - Assignees: Glycom A/S - Applicants: Glycom A/S - Inventors: Louise Kristine Vigsnæs; Bruce McConnell; Emma Elison - Web page: https://patentgrep.com/patent/US11896605B2 ## 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 1/00: Drugs for disorders of the alimentary tract or the digestive system - 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 This disclosure relates generally to compositions and methods for preventing or treating mast cell mediated visceral pain. ## Claims ### Claim 1 A method for reducing mast cell mediated visceral hypersensitivity and/or pain in a non-infant human, the method comprising: selecting 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 mast cell mediated visceral hypersensitivity and/or pain by administering to the non-infant human a 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, wherein the non-infant human has intestinal bacterial overgrowth, dysbiosis and/or an impaired mucosal barrier. ### Claim 3 (depends on 1) The method of claim 1, wherein the non-infant human is an irritable bowel syndrome (IBS) patient. ### Claim 4 (depends on 1) The method of claim 1, further comprising improving gut barrier function of the non-infant human by administering to the non-infant human the daily dose of the one or more neutral 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, further comprising administering with the selected effective amount of the chosen one or more neutral HMOs, one or more additional HMOs selected from the group consisting of 3′-sialyllactose (3′-SL) and 6′-sialyllactose (6′-SL). ### Claim 8 (depends on 1) The method of claim 1, further comprising administering the selected amount of the chosen one or more neutral HMOs for an initial treatment period of from 1 week to 8 weeks. ### Claim 9 (depends on 8) The method of claim 8, further comprising, after the initial treatment period, administering a daily dose of from 1 g to 5 g of the chosen one or more neutral HMOs for a maintenance period of at least 1 month. ### Claim 10 (depends on 1) The method of claim 1, further comprising reducing looseness and/or frequency of bowel movements of the non-infant human by administering to the non-infant human the daily dose of the one or more HMOs. ### Claim 11 A method for reducing mast cell mediated visceral hypersensitivity and/or mast cell mediated visceral pain in a non-infant human, the method comprising: selecting 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; increasing the relative abundance of Bifidobacterium adolescentis in the gastrointestinal microbiota of the non-infant human and reducing the mast cell mediated visceral hypersensitivity and/or pain by administering to the non-infant human a daily dose of from about 3 g to about 10 g of the one or more neutral HMOs; and selectively increasing expression of intestinal goblet cell genes to improve mucosal barrier function in gastrointestinal tract of the non-infant human by administering to the non-infant human the daily dose of the one or more neutral HMOs. ### Claim 12 (depends on 11) The method of claim 11, wherein selectively increasing the expression of the intestinal goblet cell genes comprises selectively increasing the expression of MUC2 and/or TTF3 genes relative to the expression of CHST5 or GAL3ST2 goblet cell genes. ### Claim 13 (depends on 11) The method of claim 11, wherein for a maintenance treatment period of at least one month following the initial treatment period, the amount of the daily dose of the chosen one or more HMOs is from about 1 g to 5 g.