IP Library Granted Patent US 11,896,604
Granted Patent B2
US 11,896,604 · App. 17/353,730 · Granted Feb 13, 2024

Composition comprising HMSs/HMOs and use thereof

Inventors: Bruce McConnell (La Tour de Peilz, CH); Emma Elison (Hjärup, SE); Louise Kristine Vigsnæs (Copenhagen NV, DK)
Assignee: Glycom A/S
A61K31/702A61K31/7016A61P1/12A61K2300/00
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Quick Facts
Patent No.
US 11,896,604
App. No.
17/353,730
Granted
Feb 13, 2024
Kind
B2
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 (35)

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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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).

9. 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.

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.

11. 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.

12. 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.

13. 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.

14. 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).

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.

16. 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.

17. 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.

18. 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.

19. 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.

20. 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.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 19, 2022
From: MCCONNELL, BRUCE; ELISON, EMMA; VIGSNÆS, LOUISE KRISTINE
To: GLYCOM A/S
Reel/Frame 061469/0541 →
Priority Claims (1)
DK PA201470663 · Oct 29, 2014 · national
Continuity (4)
Continuation 15903959 · Feb 23, 2018
Continuation In Part 15147112 · May 5, 2016
Continuation In Part 15034593
Related Publication 20210308159A1 · Oct 7, 2021