# US 11,026,959 B2 · Synthetic composition and method for treating irritable bowel syndrome

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- Number: US 11,026,959 B2
- Document ID: US11026959B2
- Status: Granted
- Kind: B2
- Application number: 15/897,099
- Filed: 2018-02-14
- Published: 2018-06-21
- Granted: 2021-06-08
- Earliest claimed: 2014-10-29
- Assignees: Glycom A/S
- Applicants: Glycom A/S
- Inventors: Thierry Hennet; Bruce McConnell; Emma Elison; Louise Kristine Vigsnæs
- Web page: https://patentgrep.com/patent/US11026959B2

## CPC

- A61K 31/702: Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
- A23C 9/206: {Colostrum; Human milk}
- A23L 33/21: Addition of substantially indigestible substances, e.g. dietary fibres
- A61K 31/7004: Monosaccharides having only carbon, hydrogen and oxygen atoms
- A61K 31/7012: Compounds having a free or esterified carboxyl group attached, directly or through a carbon chain, to a carbon atom of the saccharide radical, e.g. glucuronic acid, neuraminic acid (gluconic acid A61K31/191; ascorbic acid A61K31/375)
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs
- 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)
- A23C: DAIRY PRODUCTS, e.g. MILK, BUTTER OR CHEESE; MILK OR CHEESE SUBSTITUTES; PREPARATION THEREOF (preservation thereof A23B11/00)
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A23V: INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION

## Abstract

The application relates to a method for treating a patient with irritable bowel syndrome (IBS), the method comprising administering to the patient a mixture comprising 2′-fucosyllactose (2′-FL) and lacto-N-neotetraose (LNnT).

## Claims

### Claim 1

A method comprising:
selecting an adult human patient with irritable bowel syndrome (IBS) experiencing one or more IBS symptoms;
selecting an amount of a mixture of 2′-fucosyllactose (2′-FL) and lacto-N-neotetraose (LNnT) effective for increasing a relative abundance of Bifidobacterium adolescentis in the gastrointestinal microbiota of the adult human patient; and
increasing the relative abundance of Bifidobacterium adolescentis in the gastrointestinal microbiota of the adult human patient and reducing the likelihood of the adult human patient experiencing the one or more IBS symptoms by administering a daily dose of the selected effective amount of the mixture of 2′-FL and LNnT to the adult human patient.

### Claim 2 (depends on 1)

The method of claim 1, wherein the adult human patient has undergone treatment with an antibiotic to reduce bacteria that negatively affect the IBS, and wherein the adult human patient has not consumed the antibiotic in a three-month period prior to the administering of the selected effective amount of the mixture of 2′-FL and LNnT.

### Claim 3 (depends on 1)

The method of claim 1, wherein the one or more IBS symptoms are chronic symptoms selected from abdominal pain, abdominal discomfort, abdominal bloating, change in bowel movement patterns, diarrhea, and constipation.

### Claim 4 (depends on 1)

The method of claim 1, wherein the daily dose of the mixture of the selected effective amount of the 2′-FL and LNnT administered to the adult human patient is from about 2.5 g to about 20 g.

### Claim 5 (depends on 4)

The method of claim 4, further comprising administering with the selected effective amount of the mixture of 2′-FL and LNnT, one or more sialylated human milk oligosaccharides (HMOs) selected from 6′-sialyllactose (6′-SL) and 3′-sialyllactose (3′-SL)′.

### Claim 6 (depends on 1)

The method of claim 1, further comprising administering with the selected effective amount of the mixture of 2′-FL and LNnT, one or more neutral HMOs selected from 3-fucosyllactose (3-FL), lacto-N-fucopentaose I (LNFP-I), and difucosyllactose (DFL).

### Claim 7 (depends on 1)

The method of claim 1, wherein a mass ratio of the 2′-FL to the LNnT in the administered selected effective amount of the mixture is from about 4:1 to 1:1.

### Claim 8 (depends on 1)

The method of claim 1, wherein the selected effective amount of the mixture of the 2′-FL and LNnT is administered for a treatment period of from 1 week to 8 weeks.

### Claim 9 (depends on 1)

The method of claim 1, wherein the adult human patient is administered a daily dose of from 5 g to 10 g of the selected effective amount of the mixture of the 2′-FL and LNnT for an initial treatment period of from 1 week to 8 weeks, followed by a daily dose of from 1 g to 5 g of the selected effective amount of the mixture of the 2′-FL and LNnT for a maintenance period of at least 1 month.

### Claim 10

A method comprising:
selecting a non-infant human patient who has been previously treated for one or more symptoms associated with irritable bowel syndrome (IBS);
selecting an amount of a mixture of 2′-fucosyllactose (2′-FL) and lacto-N-neotetraose (LNnT) effective for increasing a relative abundance of Bifidobacterium adolescentis in the gastrointestinal microbiota of the non-infant human patient; and
increasing the relative abundance of Bifidobacterium adolescentis in the gastrointestinal microbiota of the non-infant human patient and reducing in the non-infant human patient a risk of re-occurrence of one or more symptoms associated with IBS by administering a daily dose of the selected effective amount of the mixture of 2′-FL and LNnT and optionally one or more excipients, to the non-infant human patient, wherein the daily dose of the mixture is from about 2.5 g to about 20 g.

### Claim 11 (depends on 10)

The method of claim 10, wherein the non-infant human patient has undergone treatment with an antibiotic and wherein the non-infant human patient has not consumed the antibiotic in a three-month period prior to the administering of the selected effective amount of the mixture of 2′-FL and LNnT.

### Claim 12 (depends on 10)

The method of claim 10, further comprising reducing the severity in the non-infant human patient of one or more chronic symptoms selected from the following group: abdominal pain, abdominal discomfort, abdominal bloating, changes in bowel movement patterns, diarrhea, and constipation, by administering the selected effective amount of the mixture of 2′-FL and LNnT to the non-infant human patient.

### Claim 13 (depends on 10)

The method of claim 10, further comprising reducing the re-occurrence in the non-infant human patient of one or more chronic symptoms selected from abdominal pain, abdominal discomfort, abdominal bloating, change in bowel movement patterns, diarrhea, and constipation, by administering the selected effective amount of the mixture of 2′-FL and LNnT to the non-infant human patient.

### Claim 14 (depends on 13)

The method of claim 13, further comprising administering with the selected effective amount of the mixture of 2′-FL and LNnT, one or more sialylated HMOs selected from 6′-sialyllactose (6′-SL) and 3′-sialyllactose (3′-SL).

### Claim 15 (depends on 10)

The method of claim 10, further comprising administering with the selected effective amount of the mixture of 2′-FL and LNnT, one or more neutral HMOs selected from 3-fucosyllactose (3-FL), lacto-N-fucopentaose I (LNFP-I), and difucosyllactose (DFL).

### Claim 16 (depends on 10)

The method of claim 10, wherein a mass ratio of the 2′-FL to the LNnT in the administered selected effective amount of the mixture is from about 4:1 to 1:1.

### Claim 17 (depends on 10)

The method of claim 10, wherein the selected effective amount of the mixture of the 2′-FL and LNnT is administered for a treatment period of from 1 week to 8 weeks.

### Claim 18 (depends on 10)

The method of claim 10, wherein the non-infant human patient is administered a daily dose of from 5 g to 10 g of the selected effective amount of the mixture of the 2′FL and LNnT for an initial treatment period of from 1 week to 8 weeks, followed by a daily dose of from 1 g to 5 g of the selected effective amount of the mixture of the 2′FL and LNnT for a maintenance period of at least 1 month.

### Claim 19

A method comprising:
selecting a non-infant human patient experiencing one or more symptoms associated with irritable bowel syndrome (IBS);
selecting an amount of a mixture of 2′-fucosyllactose (2′-FL) and lacto-N-neotetraose (LNnT) effective for increasing a relative abundance of Bifidobacterium adolescentis in the gastrointestinal microbiota of the non-infant human patient; and
increasing the relative abundance of Bifidobacterium adolescentis in the gastrointestinal microbiota of the non-infant human patient and reducing in the non-infant human patient the level of one or more inflammatory biomarkers or symptoms associated with the IBS by administering a daily dose of the selective effective amount of the mixture of 2′FL and LNnT to the non-infant human patient.

### Claim 20 (depends on 19)

The method of claim 19, wherein the one or more inflammatory biomarkers associated with the IBS are selected from tumor necrosis factor alpha (TNFα), interleukin 6 (IL-6), high-sensitivity C-reactive protein (hs-CRP), and lipopolysaccharide binding protein (LBP).