# US 11,439,672 B2 · Methods for the dietary management of irritable bowel syndrome and carbohydrate malabsorption

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- Number: US 11,439,672 B2
- Document ID: US11439672B2
- Status: Granted
- Kind: B2
- Application number: 16/174,117
- Filed: 2018-10-29
- Published: 2019-02-28
- Granted: 2022-09-13
- Earliest claimed: 2003-12-05
- Assignees: Ganeden Biotech, Inc.
- Applicants: Ganeden Biotech, Inc.
- Inventors: Sean Farmer; Andrew R. Lefkowitz
- Web page: https://patentgrep.com/patent/US11439672B2

## CPC

- A61K 35/742: Spore-forming bacteria, e.g. Bacillus coagulans, Bacillus subtilis, clostridium or Lactobacillus sporogenes
- 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 33/175: Amino acids
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 35/744: Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
- A61K 38/465: {acting on ester bonds (3.1), e.g. lipases, ribonucleases}
- A61K 38/47: acting on glycosyl compounds (3.2), e.g. cellulases, lactases
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 1/12: Antidiarrhoeals
- 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 2035/11: {Medicinal preparations comprising living procariotic cells}
- 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

The invention relates generally to digestive disorders, and in particular to methods for treating irritable bowel syndrome by increasing carbohydrate absorption by administering a composition containing a Bacillus coagulans bacterium.

## Claims

### Claim 1

A method of reducing a symptom of irritable bowel syndrome, improving stool consistency in a patient afflicted with non-constipated irritable bowel syndrome, decreasing urgency in a patient afflicted with irritable bowel syndrome, increasing lactose digestion, managing or increasing a subject's carbohydrate absorption, or increasing carbohydrate absorption in a subject, comprising:
identifying a patient suffering from or at risk of developing irritable bowel syndrome, and
administering to said patient a composition comprising Bacillus coagulans bacteria selected from the group consisting of GBI-20 (ATCC Designation Number PTA-6085), GBI-30 (ATCC Designation Number PTA-6086), and GBI-40 (ATCC Designation Number PTA-6087),
wherein said composition further comprises a lactase, and a ratio of the lactase IU to the Bacillus coagulans bacteria is from 1:10 to 10:1, and
wherein said symptom includes alternating diarrhea and constipation.

### Claim 2 (depends on 1)

The method of claim 1, wherein said bacteria is derived from Bacillus coagulans hammer strain Accession No. ATCC 31284.

### Claim 3 (depends on 1)

The method of claim 1, wherein said composition further comprises a supplementary enzyme, wherein said enzyme is selected from the group consisting of a lactase, a fructase, a lipase, an amylase and a protease.

### Claim 4 (depends on 1)

The method of claim 1, wherein said symptom is selected from the group consisting of gas, bloating and intestinal discomfort.

### Claim 5 (depends on 1)

The method of claim 1, wherein said composition further comprises an anti-gas agent, an anti-diarrheal agent or a laxative agent.

### Claim 6 (depends on 5)

The method of claim 5, wherein said anti-gas agent is selected from the group of α-galactosidase enzyme, simethicone, calcium carbonate, aluminum hydroxide and magnesium hydroxide.

### Claim 7 (depends on 5)

The method of claim 5, wherein said anti-diarrheal agent is selected from the group consisting of loperamide, attapulgite, Croton Lechleri Extract, and calcium polycarbophil.

### Claim 8 (depends on 5)

The method of claim 5, wherein said laxative agent is selected from the group consisting of a sennoside, docusate sodium, magnesium hydroxide, and a dietary fiber.

### Claim 9 (depends on 1)

The method of claim 1, wherein said Bacillus coagulans bacteria are provided in an amount of from about 1×108 to about 1×1010 viable bacteria.

### Claim 10 (depends on 1)

The method of claim 1, wherein the Bacillus coagulans bacteria are in the form of spores, vegetative cells or a combination thereof.

### Claim 11 (depends on 1)

The method of claim 1, wherein said composition further comprises a lactase, and said composition comprises a ratio of about 1 IU of the lactase to about every 3 Bacillus coagulans bacteria.

### Claim 12 (depends on 1)

The method of claim 1, wherein the ratio of the lactase IU to the Bacillus coagulans bacteria is from 1:3 to 3:1.

### Claim 13 (depends on 1)

The method of claim 1, wherein the ratio of the lactase to the Bacillus coagulans bacteria is 1:1 to 1:5.

### Claim 14 (depends on 1)

The method of claim 1, wherein said composition further comprises a fructase, and said Bacillus coagulans bacteria is provided at a concentration of from about 1×108 to about 1×1010 viable bacteria.

### Claim 15 (depends on 1)

The method of claim 1, wherein said Bacillus coagulans bacteria is substantially purified.

### Claim 16 (depends on 1)

The method of claim 1, wherein said composition further comprises a lactase, and said composition does not contain Lactobacillus acidophilus bacteria.

### Claim 17 (depends on 16)

The method of claim 16, wherein said composition comprises a ratio of about 1 IU of the lactase to about every 3 Bacillus coagulans bacteria.

### Claim 18 (depends on 17)

The method of claim 17, wherein said Bacillus coagulans bacteria is provided at a concentration of from about 1×108 to about 1×1010 viable bacteria.