# US 11,998,577 B2 · Methods for increasing growth of beneficial bacteria in the gastrointestinal tract

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- Number: US 11,998,577 B2
- Document ID: US11998577B2
- Status: Granted
- Kind: B2
- Application number: 17/682,051
- Filed: 2022-02-28
- Published: 2023-03-09
- Granted: 2024-06-04
- Earliest claimed: 2017-06-21
- Assignees: Abbott Laboratories
- Applicants: Abbott Laboratories
- Inventors: Alejandro Barranco Perez; Maria Ramirez Gonzalez; Rachael Buck; Enrique Vazquez Hernandez
- Web page: https://patentgrep.com/patent/US11998577B2

## CPC

- A61K 35/747: Lactobacilli, e.g. L. acidophilus or L. brevis
- A23L 33/10: using additives (addition of substantially indigestible substances A23L33/21)
- A23L 33/125: containing carbohydrate syrups; containing sugars; containing sugar alcohols; containing starch hydrolysates (indigestible substances A23L33/21)
- A23L 33/135: Bacteria or derivatives thereof, e.g. probiotics
- A23L 33/15: Vitamins
- A23L 33/40: {Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula}
- A61K 9/107: Emulsions {; Emulsion preconcentrates; Micelles (composition of emulsions A61K47/00)}
- A61K 31/015: carbocyclic
- A61K 31/047: having two or more hydroxy groups, e.g. sorbitol
- A61K 31/07: Retinol compounds, e.g. vitamin A (retinoic acids A61K31/203)
- A61K 31/122: having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
- A61K 31/14: Quaternary ammonium compounds, e.g. edrophonium, choline (betaines A61K31/205)
- A61K 31/145: having sulfur, e.g. thiurams (>N—C(S)—S—C(S)—N< and >N—C(S)—S—S—C(S)—N<), Sulfinylamines (—N=SO), Sulfonylamines (—N=SO2) (isothiourea A61K31/155)
- A61K 31/205: Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
- A61K 31/355: Tocopherols, e.g. vitamin E
- A61K 31/405: Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
- A61K 31/4188: condensed with other heterocyclic ring systems, e.g. biotin, sorbinil
- A61K 31/4415: Pyridoxine, i.e. Vitamin B6 (pyridoxal phosphate A61K31/675)
- A61K 31/519: ortho- or peri-condensed with heterocyclic rings
- A61K 31/525: Isoalloxazines, e.g. riboflavins, vitamin B2
- A61K 31/593: 9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
- A61K 31/702: Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
- A61K 31/7072: having two oxo groups directly attached to the pyrimidine ring, e.g. uridine, uridylic acid, thymidine, zidovudine
- A61K 31/7076: containing purines, e.g. adenosine, adenylic acid
- A61K 31/708: having oxo groups directly attached to the purine ring system, e.g. guanosine, guanylic acid
- A61K 31/714: Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
- A61K 33/06: Aluminium, calcium or magnesium; Compounds thereof {, e.g. clay}
- A61K 33/26: Iron; Compounds thereof
- A61K 33/30: Zinc; Compounds thereof
- A61K 35/20: Milk; Whey; Colostrum
- A61K 35/745: Bifidobacteria
- A61K 47/02: Inorganic compounds
- A61K 47/12: Carboxylic acids; Salts or anhydrides thereof
- A61K 47/14: Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
- A61K 47/22: Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
- A61K 47/24: containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
- A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- A61K 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K 47/42: Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein (oligopeptides having up to five amino acids {A61K47/183}; polyamino acids A61K47/34)
- A61K 47/44: Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin (synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14)
- A61K 47/46: Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
- A61P 1/14: Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
- 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)
- 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

Disclosed are nutritional compositions including 2′-fucosyllactose (2′-FL) in combination with lutein and RRR-alpha-tocopherol. The nutritional compositions are useful for improving at least one of gut function, health, and development in an individual. In certain embodiments, the nutritional compositions can improve growth or maturation of the gut, as well as promote a healthy balance of beneficial bacteria in the gastrointestinal tract thereby treating and/or preventing formula intolerance or other gastrointestinal diseases and/or disorders resulting from suboptimal gastrointestinal flora population/balance.

## Claims

### Claim 1

A method of improving the feeding tolerance of an infant in need thereof, the method comprising administering a therapeutically effective amount of a nutritional composition comprising 2′-fucosyllactose, lutein, and RRR-alpha-tocopherol to the infant.

### Claim 2 (depends on 1)

The method of claim 1, wherein administration increases beneficial bacteria in the gut of the infant.

### Claim 3 (depends on 1)

The method of claim 1, wherein the nutritional composition comprises 2′-fucosyllactose in an amount of about 0.02 mg/mL to about 20 mg/mL.

### Claim 4 (depends on 1)

The method of claim 1, wherein the nutritional composition comprises lutein in an amount of about 0.001 mg/mL to about 5 mg/mL.

### Claim 5 (depends on 1)

The method of claim 1, wherein the nutritional composition comprises RRR-alpha-tocopherol in an amount of about 3 mg/L to about 100 mg/L.

### Claim 6 (depends on 1)

The method of claim 1, wherein the nutritional composition is an infant formula.

### Claim 7 (depends on 1)

The method of claim 1, wherein the nutritional composition further comprises a probiotic.

### Claim 8 (depends on 7)

The method of claim 7, wherein the probiotic is a Bifidobacteria.

### Claim 9 (depends on 1)

The method of claim 1, wherein the nutritional composition further comprises at least one human milk oligosaccharide selected from the group consisting of 3-fucosyllactose, 3′-sialylactose, 6′-sialylactose, and lacto-N-tetraose.
