# US 2018/0021391 A1 · Bifidobacteria for treating diabetes and related conditions

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- Number: US 2018/0021391 A1
- Document ID: US20180021391A1
- Status: Published application
- Kind: A1
- Application number: 15/452,240
- Filed: 2017-03-07
- Published: 2018-01-25
- Earliest claimed: 2009-06-19
- Applicants: Dupont Nutrition Biosciences Aps
- Inventors: REMY BURCELIN; DIDIER CARCANO; SAMPO LAHTINEN
- Web page: https://patentgrep.com/patent/US20180021391A1

## CPC

- A61K 35/745: Bifidobacteria
- A23C 9/123: using only microorganisms of the genus lactobacteriaceae; Yoghurt (A23C9/13 takes precedence)
- A23L 33/135: Bacteria or derivatives thereof, e.g. probiotics
- A61K 31/155: Amidines ([IMAGE cpc-sch-A61K-1029.gif]), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
- A61K 31/715: Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K 35/747: Lactobacilli, e.g. L. acidophilus or L. brevis
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 3/04: Anorexiants; Antiobesity agents
- A61P 5/50: for increasing or potentiating the activity of insulin
- A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs
- A23V 2400/515: Animalis
- A61K 2035/115: {Probiotics}
- A61K 2300/00: Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
- 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)
- A23C: DAIRY PRODUCTS, e.g. MILK, BUTTER OR CHEESE; MILK OR CHEESE SUBSTITUTES; PREPARATION THEREOF (preservation thereof A23B11/00)
- 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

This invention relates to new uses of Bifidobacteria (particularly, although not exclusively, probiotic Bifidobacteria), and to food products, feed products, dietary supplements and pharmaceutical formulations containing them. The bacteria are suitable for the treatment of diabetes (particularly Type 2 diabetes), obesity and related conditions, metabolic syndrome, insulin resistance, and impaired glucose metabolism and consequences thereof, lowering tissue inflammation, treating hepatitis, myositis and cardiovascular conditions.

## Claims

### Claim at position 1

1-44. (canceled)

### Claim 45

A method of treating a disease or condition in a mammal, wherein:
the method comprises administering to a mammal in need of such treatment a combination of (i) a bacterium of the genus Bifidobacterium and (ii) an antidiabetic drug; and
the disease or condition is selected from:
(a) diabetes;
(b) metabolic syndrome;
(c) impaired glucose tolerance;
(d) reduced insulin sensitivity;
(e) reduced fed insulin secretion;
(f) elevated fasted insulin secretion;
(g) obesity;
(h) weight gain;
(i) elevated body fat mass; and
(j) elevated mesenteric fat mass.

### Claim 46 (depends on 45)

The method of claim 45, wherein:
the method comprises treating diabetes, and
the diabetes is Type 2 diabetes.

### Claim at position 4

47-51. (canceled)

### Claim 52 (depends on 45)

The method of claim 45, wherein the mammal in need of the treatment ingests a high-fat diet.

### Claim 53 (depends on 45)

The method of claim 45, wherein the Bifidobacterium is a probiotic Bifidobacterium.

### Claim 54 (depends on 45)

The method of claim 45, wherein the Bifidobacterium is selected from the species Bifidobacterium lactis, Bifidobacterium bifidium, Bifidobacterium longum, Bifidobacterium animalis, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium catenulatum, Bifidobacterium pseudocatenulatum, Bifidobacterium adolescentis, and Bifidobacterium angulatum.

### Claim 55 (depends on 54)

The method of claim 54, wherein the Bifidobacterium is of the species Bifidobacterium animalis.

### Claim 56 (depends on 55)

The method of claim 55, wherein the Bifidobacterium is of the species Bifidobacterium animalis subsp. lactis.

### Claim 57

The method of 45, wherein the Bifidobacterium is of the species Bifidobacterium animalis subsp. lactis strain 420 (B420).

### Claim 58 (depends on 45)

The method of claim 45, wherein the Bifidobacterium and antidiabetic drug are administered in combination with an additional bacterium of the genus Lactobacillus.

### Claim 59 (depends on 58)

The method of claim 58, wherein the additional bacterium is of the species Lactobacillus acidophilus.

### Claim 60 (depends on 59)

The method of claim 59, wherein the additional bacterium is Lactobacillus acidophilus strain NCFM (ATCC PTA-4797).

### Claim 61 (depends on 45)

The method of claim 45, wherein the Bifidobacterium and antidiabetic drug are administered in combination with a prebiotic.

### Claim 62 (depends on 61)

The method of claim 61, wherein the prebiotic is polydextrose.

### Claim 63

(canceled)

### Claim 64 (depends on 45)

The method of claim 45, wherein the antidiabetic drug is selected from a biguanide, a sulfonylurea, an alpha-glucosidase inhibitor, a thiazolidinedione, a meglitinide, a dipeptidyl peptidase-4 (DPP-4) inhibitor, a glucagon-like peptide-1 analog, an amylin analog, a fast acting insulin analog, a long acting insulin analog, a dual PPAR agonist and an SGLT2 inhibitor.

### Claim 65 (depends on 45)

The method of claim 45, wherein the antidiabetic drug is a biguanide.

### Claim 66 (depends on 45)

The method of claim 45, wherein the antidiabetic drug is metformin.

### Claim 67 (depends on 45)

The method of claim 45, wherein the bacterium and antidiabetic drug are administered to the mammal as part of a food product, feed product, dietary supplement or medicament.

### Claim 68 (depends on 45)

The method of claim 45, wherein a mixture of at least two Bifidobacterium strains are administered to the mammal.

### Claim 69 (depends on 45)

The method of claim 45, wherein at least two of the diseases or conditions (a)-(j) are treated.

### Claim 70 (depends on 45)

The method of claim 45, wherein the antidiabetic drug is selected from metformin, carbutamide, chlorpropamide, glibenclamide, gliclazide, glimepiride, glipizide, gliquidone, tolazamide, tolbutamide), acarbose, miglitol, voglibose, pioglitazone, rivoglitazone, rosiglitazone, nateglinide, repaglinide, mitiglinide, alogliptin, saxagliptin, sitagliptin, vildagliptin, exenatide, liraglutide, albiglutide, pramlintide, insulin lispro, insulin aspart, insulin glulisine, insulin glargine, insulin detemir, aleglitazar, dapagliflozin, remogliflozin and sergliflozin.

### Claim 71 (depends on 70)

The method of claim 70, wherein the antidiabetic drug is selected from alogliptin, saxagliptin, sitagliptin and vildagliptin.

### Claim 72 (depends on 64)

The method of claim 64, wherein the antidiabetic drug is a dipeptidyl peptidase-4 (DPP-4) inhibitor.