# US 12,109,220 B2 · Compositions for use in the reduction of nociception in children

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- Number: US 12,109,220 B2
- Document ID: US12109220B2
- Status: Granted
- Kind: B2
- Application number: 17/747,106
- Filed: 2022-05-18
- Published: 2022-10-20
- Granted: 2024-10-08
- Earliest claimed: 2017-12-22
- Assignees: Societe des Produits Nestle S.A.
- Applicants: Societe Des Produits Nestle S.A.
- Inventors: Sami Damak; Norbert Sprenger; Francis Foata
- Web page: https://patentgrep.com/patent/US12109220B2

## CPC

- A23L 33/125: containing carbohydrate syrups; containing sugars; containing sugar alcohols; containing starch hydrolysates (indigestible substances A23L33/21)
- A61K 31/702: Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
- A23L 33/40: {Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula}
- A61K 9/0056: {Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals}
- A61K 9/0095: {Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches (A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006)}
- A61K 31/7016: Disaccharides, e.g. lactose, lactulose (lactobionic acid A61K31/7032)
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)
- 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

Compositions contain 6′-sialyllactose (6′ SL) and lacto-N-tetraose (LNT), for use in the reduction of nociception in an infant or in a young child. The compositions are in particular useful in reducing abdominal pain, such as pain associated with infantile colic, irritable bowel syndrome (IBS) and/or recurrent abdominal pain (RAP), and consequently also contribute to reducing the crying periods and to improving the quality of sleep and the general quality of life of the infants and young children.

## Claims

### Claim 1

A method for reducing nociception in a child in need thereof, the method comprising administering to the child a growing-up milk comprising 6′-sialyllactose (6′SL) and lacto-N-tetraose (LNT), wherein the growing-up milk does not include any fucosylated oligosaccharide.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the growing-up milk is administered in an effective amount for reducing abdominal pain in the child.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the growing-up milk is administered in an effective amount for reducing pain associated with gastrointestinal discomfort and/or with a gastrointestinal disorder.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the growing-up milk is administered in an effective amount for reducing crying periods in the child.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the growing-up milk is administered in an effective amount for improving the quality of sleep in the child.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the growing-up milk is administered in an effective amount for improving the quality of life in the child.

### Claim 7 (depends on 1)

The method according to claim 1, wherein the child experiences abdominal pain.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the child experiences pain associated with gastrointestinal discomfort and/or gastrointestinal disorder.

### Claim 9 (depends on 1)

The method according to claim 1, wherein the growing-up milk further comprises at least one probiotic in an amount of from 103 to 1012 cfu/g of the growing-up milk by dry weight.

### Claim 10 (depends on 1)

The method according to claim 1, wherein the 6′SL and the LNT are present in a weight ratio 6′ SL:LNT from 3:1 to 1:3.

### Claim 11 (depends on 1)

The method according to claim 1, wherein the 6′SL is present in an amount of 0.005 to 5 g/L or 0.004 to 3.8 g/100 g of the growing-up milk on a dry weight basis.

### Claim 12 (depends on 1)

The method according to claim 1, wherein the LNT is present in an amount of 0.005-3 g/L or 0.004-2.3 g/100 g of the growing-up milk on a dry weight basis.

### Claim 13 (depends on 1)

The method according to claim 1, wherein:
a. the 6′SL is in an amount of 0.005-5 g/L of the growing-up milk and/or in an amount of 0.004-3.8 g/100 g of the growing-up milk on a dry weight basis; and/or
b. the LNT is in an amount of 0.005-3 g/L of the growing-up milk and/or in an amount of 0.004-2.3 g/100 g of the growing-up milk on a dry weight basis.

### Claim 14 (depends on 1)

The method according to claim 1, wherein:
a. the 6′SL is in an amount of 0.008-2.5 g/L of the growing-up milk and/or in an amount of 0.006-1.9 g/100 g of the growing-up milk on a dry weight basis; and/or
b. the LNT is in an amount of 0.01-1.5 g/L of the growing-up milk and/or in an amount of 0.008-1.2 g/100 g of the growing-up milk on a dry weight basis.

### Claim 15 (depends on 1)

The method according to claim 1, wherein:
a. the 6′SL is in an amount of 0.01-1 g/L of the growing-up milk and/or in an amount of 0.008-0.8 g/100 g of the growing-up milk on a dry weight basis; and/or
b. the LNT is in an amount of 0.04-1.2 g/L of the growing-up milk and/or in an amount of 0.03-0.9 g/100 g of the growing-up milk on a dry weight basis.

### Claim 16 (depends on 1)

The method according to claim 1, wherein:
a. the 6′SL is in an amount of 0.03-0.7 g/L of the growing-up milk and/or in a total amount of 0.023-0.5 g/100 g of the growing-up milk on a dry weight basis; and/or
b. the LNT is in an amount of 0.05-1 g/L of the growing-up milk and/or in an amount of 0.04-0.8 g/100 g of the growing-up milk on a dry weight basis.

### Claim 17 (depends on 1)

The method according to claim 1, wherein:
a. the 6′SL is in an amount of 0.04-0.5 g/L of the growing-up milk and/or in an amount of 0.031-0.4 g/100 g of the growing-up milk on a dry weight basis; and/or
b. the LNT is in an amount of 0.09-0.8 g/L of the growing-up milk and/or in an amount of 0.07-0.6 g/100 g of the growing-up milk on a dry weight basis.

### Claim 18 (depends on 1)

The method according to claim 1, wherein the growing-up milk further comprises at least one additional ingredient selected from the group consisting of N-acetylated oligosaccharides, sialylated oligosaccharides, galacto-oligosaccharides (GOS), fructo-oligosaccharides (FOS), xylooligosaccharides (XOS), inulin, polydextrose, sialic acid, fucose and any combination thereof.

### Claim 19 (depends on 1)

The method according to claim 1, wherein the child has inflammatory bowel disease (IBD).