# US 11,998,558 B2 · Synthetic composition for treating antibiotic associated complications

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- Number: US 11,998,558 B2
- Document ID: US11998558B2
- Status: Granted
- Kind: B2
- Application number: 17/120,881
- Filed: 2020-12-14
- Published: 2021-04-08
- Granted: 2024-06-04
- Earliest claimed: 2015-11-17
- Assignees: Glycom A/S
- Applicants: Glycom A/S
- Inventors: Bruce McConnell; Louise Kristine Vigsnæs; David Paul Kronlage
- Web page: https://patentgrep.com/patent/US11998558B2

## CPC

- A61K 31/702: Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
- A23L 33/125: containing carbohydrate syrups; containing sugars; containing sugar alcohols; containing starch hydrolysates (indigestible substances A23L33/21)
- A61P 31/04: Antibacterial agents
- A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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)
- 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
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The invention relates to a synthetic composition comprising human milk oligosaccharides for use in at least partially restoring the commensal gastrointestinal microbiota and preventing or mitigating antibiotic associated diarrhoea.

## Claims

### Claim 1

A method of treating a disorder associated with antibiotic therapy comprising administering daily to a human in need thereof at least 2 g of a synthetic composition consisting essentially of one or more human milk oligosaccharides (HMOs) selected from the group consisting of fucosylated HMOs and core HMOs, and optionally, a probiotic,
wherein the disorder associated with antibiotic therapy is selected from the group consisting of diarrhoea, dysbiosis of the lower gastro-intestinal tract, and primary or recurrent Clostridium difficile infection, and wherein the human is undergoing or had previously undergone antibiotic therapy.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the fucosylated HMO is selected from the group consisting of 2′-FL, DFL and a mixture thereof; and the core HMO is selected from the group consisting of LNT, LNnT and a mixture thereof.

### Claim 3

The method according to 1, wherein the one or more HMOs consists essentially of a mixture of one or more fucosylated HMOs and one or more core HMOs.

### Claim 4 (depends on 3)

The method according to claim 3, wherein the mixture consists of 2′-FL and LNnT.

### Claim 5 (depends on 3)

The method according to claim 3, wherein the mixture of one or more fucosylated HMOs and one or more core HMOs is in a ratio from about 1.5:1 to about 5:1 by weight.

### Claim 6 (depends on 1)

The method according to claim 1, in which the one or more HMOs are administered neat, as diluted with water or in one or more unit dosage forms.

### Claim 7 (depends on 1)

The method according to claim 1, wherein the amount of the one or more HMOs is from about 2 g to about 10 g.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the one or more HMOs is administered daily during the treatment period and for at least 14 days after termination of antibiotic therapy, or at least 14 days after termination of antibiotic therapy.

### Claim 9 (depends on 1)

The method according to claim 1, wherein the human is a child of 3 years of age or older or an elderly person of 60 years of age or older.

### Claim 10 (depends on 1)

The method according to claim 1, wherein the antibiotic therapy comprises a broad spectrum antibiotic.