# US 2014/0193542 A1 · Protein free formula

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- Number: US 2014/0193542 A1
- Document ID: US20140193542A1
- Status: Published application
- Kind: A1
- Application number: 14/206,173
- Filed: 2014-03-12
- Published: 2014-07-10
- Earliest claimed: 2006-08-04
- Assignees: Shs International Ltd.
- Applicants: SHS International
- Inventors: Jane Elizabeth Langford; Ian Sullivan; Catherine Teresa Deering; Sandra Helen Giffen
- Web page: https://patentgrep.com/patent/US20140193542A1

## CPC

- A23L 33/40: {Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula}
- A23D 9/013: Other fatty acid esters, e.g. phosphatides
- A23L 33/12: Fatty acids or derivatives thereof
- A23L 33/135: Bacteria or derivatives thereof, e.g. probiotics
- A23L 33/16: Inorganic salts, minerals or trace elements
- A23L 33/17: Amino acids, peptides or proteins
- A23L 33/175: Amino acids
- A23L 33/18: Peptides; Protein hydrolysates
- A23L 33/21: Addition of substantially indigestible substances, e.g. dietary fibres
- A23L 33/25: Synthetic polymers, e.g. vinylic or acrylic polymers
- A61K 31/198: Alpha-amino acids, e.g. alanine or edetic acid [EDTA] (betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00)
- A61K 31/202: having three or more double bonds, e.g. linolenic (eicosanoids, e.g. leukotrienes A61K31/557)
- A61K 31/232: having three or more double bonds, e.g. etretinate
- A61K 31/568: substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
- A61K 31/70: Carbohydrates; Sugars; Derivatives thereof (sorbitol A61K31/047)
- A61K 35/74: Bacteria (therapeutic use of a bacterial protein A61K38/00)
- A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00)
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 1/08: for nausea, cinetosis or vertigo; Antiemetics
- A61P 1/12: Antidiarrhoeals
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 11/06: Antiasthmatics
- A61P 17/00: Drugs for dermatological disorders
- A61P 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14)
- C11C 1/045: {using enzymes or microorganisms, living or dead}
- A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)
- A23D: EDIBLE OILS OR FATS, e.g. MARGARINES, SHORTENINGS OR COOKING OILS (preservation thereof A23B20/00; production, refinement or preservation of animal or vegetable fats or oils C11B, C11C)
- 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
- C11C: FATTY ACIDS FROM FATS, OILS OR WAXES; CANDLES; FATS, OILS OR FATTY ACIDS BY CHEMICAL MODIFICATION OF FATS, OILS, OR FATTY ACIDS OBTAINED THEREFROM
- 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 invention relates to the use of composition comprising free amino acids as a sole source of protein, a fatty acid source comprising long chain polyunsaturated fatty acids, a carbohydrate source comprising digestible and indigestible carbohydrates, and milk protein free Bifidobacteria for treating a person suffering from (a) colic, congestion, runny nose, wheezing, vomiting, diarrhoea, bloody stools, mucus in stools, rash, eczema, gastroesophageal reflux, eosinophilic esophagitis or asthma; (b) cow's milk allergy and/or food protein intolerance; and/or (c) infections, wherein the indigestible carbohydrate is selected from a milk protein free source and the total composition is essentially free of intact proteins.

## Claims

### Claim 1

A composition comprising a protein component, a fat component, a digestible carbohydrate component, a non-digestible carbohydrate and Bifidobacteria wherein;
(a) the protein component contains more than 99 wt. % free amino acids based on total protein, and comprising at least the following free amino acids: alanine, arginine, aspartic acid, cysteine, glycine, histidine, isoleucine, leucine, lysine, methionine, proline, serine, threonine, tryptophan, tyrosine, valine and glutamine;
(b) the digestible carbohydrate component contain less than 2 wt % lactose based on total digestible carbohydrate;
(c) the non-digestible carbohydrate comprises soluble fructan with an average DP between 2 to 200; and
(d) the fat component comprises between 0.1 wt % and 5 wt % LCPUFA based on total fatty acid content.

### Claim 2 (depends on 1)

A composition according to claim 1 wherein the fat component comprises between 0.2 wt % and 1 wt % LCPUFA based on the total fatty acid content.

### Claim 3 (depends on 1)

A composition according to claim 1, further comprising a non-digestible, soluble galacturonic acid with an average DP between 2 and 200.

### Claim 4 (depends on 1)

A composition according to claim 1, comprising Bifidobacterium breve.

### Claim 5 (depends on 1)

A composition according to claim 1, comprising arachidonic acid and/or docosahexaenoic acid.

### Claim 6 (depends on 1)

A composition according to claim 1, wherein the non-digestible carbohydrate consists of long chain FOS and short chain FOS.

### Claim 7 (depends on 6)

A composition according to claim 6 wherein the long chain FOS has an average DP between 10-60 and the short chain FOS has an average DP between 3 and 10.

### Claim 8 (depends on 1)

A composition according to claim 1 wherein the product is a powder or a liquid.

### Claim 9

A milk protein-free composition comprising:
(a) a protein-free portion consisting of:
(i) free amino acids as the sole source of amino acids in the protein-free portion, wherein the free amino acids comprise at least alanine, arginine, aspartic acid, cysteine, glycine, histidine, isoleucine, leucine, lysine, methionine, proline, serine, threonine, tryptophan, tyrosine, valine, and glutamine,
(ii) fatty acids comprising long-chain polyunsaturated fatty acids (LCPUFA),
(iii) digestible carbohydrates, and
(iv) indigestible carbohydrates obtained from a milk protein-free source; and
(b) Bifidobacteria obtained from a milk-protein-free culture;
wherein the milk protein-free composition is free of protein fragments of milk, and other than (b) is essentially free of intact proteins.

### Claim 10 (depends on 9)

A composition according to claim 9 wherein the fat component comprises between 0.2 wt % and 1 wt % LCPUFA based on the total fatty acid content.

### Claim 11 (depends on 9)

A composition according to claim 9, further comprising indigestible, soluble fructan with an average DP between 2 to 200.

### Claim 12 (depends on 11)

A composition according to claim 11, further comprising an indigestible, soluble galacturonic acid with an average DP between 2 and 200.

### Claim 13 (depends on 9)

A composition according to claim 9, comprising Bifidobacterium breve.

### Claim 14 (depends on 9)

A composition according to claim 9, comprising arachidonic acid and/or docosahexaenoic acid.

### Claim 15 (depends on 9)

A composition according to claim 9, wherein the indigestible carbohydrate consists of long chain FOS and short chain FOS.

### Claim 16 (depends on 15)

A composition according to claim 15 wherein the long chain FOS has an average DP between 10-60 and the short chain FOS has an average DP between 3 and 10.

### Claim 17 (depends on 9)

A composition according to claim 9 wherein the product is a powder or a liquid.