# US 11,992,510 B2 · Probiotic formulations for the treatment and alleviation of metabolic and oxidative stress, inflammation and neurodegeneration

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 11,992,510 B2
- Document ID: US11992510B2
- Status: Granted
- Kind: B2
- Application number: 16/969,759
- Filed: 2019-02-12
- Published: 2020-12-31
- Granted: 2024-05-28
- Earliest claimed: 2018-02-13
- Assignees: Proviva Pharma Inc.
- Applicants: Proviva Pharma Inc.
- Inventors: Susan Westfall; Satya Prakash
- Web page: https://patentgrep.com/patent/US11992510B2

## CPC

- A61K 35/745: Bifidobacteria
- A23K 10/18: of live microorganisms
- A23L 33/135: Bacteria or derivatives thereof, e.g. probiotics
- A61K 35/747: Lactobacilli, e.g. L. acidophilus or L. brevis
- A61K 36/185: Magnoliopsida (dicotyledons)
- A61K 36/47: Euphorbiaceae (Spurge family), e.g. Ricinus (castorbean)
- A61K 2035/115: {Probiotics}
- 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)
- A23K: FODDER
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)

## Abstract

In alternative embodiments, provided are probiotic formulations, including compositions, formulations, products of manufacture and kits comprising them, and methods of using them, for the treatment and alleviation of metabolic and oxidative stress, inflammation and neurodegeneration. In alternative embodiments, probiotic formulations as provided herein comprise or consist of any combination of the three probiotic strains: Lactobacillus fermentum NCIMB 5221, Lactobacillus plantarum NCIMB 8826 and Bifidobacteria longum spp. infantis NCIMB 702255. In alternative embodiments, probiotic formulations as provided herein are combined with a triphala. In alternative embodiments, probiotic formulations as provided herein are used for: the treatment of metabolic conditions such as diabetes and obesity, inflammatory conditions such as IBD, IBS, arthritis; and, neurodegenerative diseases such as Alzheimer's disease and Parkinson's disease. In alternative embodiments, probiotic formulations as provided herein are used for: resisting oxidative stress, reducing inflammation, lowering blood and total glucose levels, lowering triglycerides levels and managing insulin resistance.

## Claims

### Claim 1

A method of lowering circulating blood glucose level and total glucose level, lowering triglyceride level, and managing insulin resistance in an individual in need thereof,
comprising administering to the individual about one to four dosages of a probiotic formulation comprising a combination of three isolated bacterial strains, wherein the three isolated bacterial strains are Lactobacillus fermentum NCIMB 5221, isolated Lactobacillus plantarum NCIMB 8826, and isolated Bifidobacterium longum NCIMB 702255, wherein the lowering is when compared to a corresponding individual not administered with the formulation.

### Claim 2 (depends on 1)

The method of claim 1, wherein the individual has type II diabetes, insulin resistance, hyperglycemia, or hyperglyceridemia.

### Claim 3 (depends on 1)

The method of claim 1, wherein a prebiotic composition is also administered to the individual.

### Claim 4 (depends on 3)

The method of claim 3, wherein the prebiotic composition is polyherbal comprising equal amounts of Emblica offcinalis, Terminalia chebula and Terminalia belerica.

### Claim 5 (depends on 1)

The method of claim 1, wherein the three bacterial strains are live or dead.

### Claim 6 (depends on 1)

The method of claim 1, wherein each of the three bacterial strains is present at 1×105 CFU/ml to 1011 CFU/ml of the formulation, or between 105 CFU/gm and 3.0×1011 CFU/gm of the formulation.

### Claim 7 (depends on 1)

The method of claim 1, wherein the total of the three bacterial strains present is 3.0×109 CFU/ml or 3.0×109 CFU/gm of the formulation.

### Claim 8 (depends on 1)

The method of claim 1, wherein each of the three bacterial strains is present at 1.0×109 CFU/ml.

### Claim 9 (depends on 1)

The method of claim 1, wherein the individual is a human or an animal.

### Claim 10 (depends on 1)

The method of claim 1, wherein the formulation is in the form of a solution, a suspension, an emulsion, a powder, a lozenge, a pill, a syrup, a tablet, a capsule, a geltab, an aerosol, a suppository, a chewing gum, a capsule or a sachet.

### Claim 11 (depends on 1)

The method of claim 1, wherein the formulation is administered in an edible material, a drink, or a foodstuff.

### Claim 12 (depends on 1)

The method of claim 1, wherein the formulation is administered in a fluid or solid dairy product, milk or condensed milk, drinkable yogurt, yogurt, fermented beverage, ice cream, cheese, soy milk, vegetable juice, fruit juice, sports drink, dessert, jelly, candy, baby food, health food, dietary supplement, or dietary additive.

### Claim 13

A method of slowing the onset or progression of metabolic stress, oxidative stress, and inflammation in an individual in need thereof,
comprising administering to the individual about one to four dosages of a probiotic formulation comprising a combination of three isolated bacterial strains, wherein the three isolated bacterial strains are Lactobacillus fermentum NCIMB 5221, isolated Lactobacillus plantarum NCIMB 8826, and isolated Bifidobacterium longum NCIMB 702255.

### Claim 14 (depends on 13)

The method of claim 13, wherein the individual has oxidative stress and/or inflammation.

### Claim 15 (depends on 13)

The method of claim 13, wherein a prebiotic composition is also administered to the individual.

### Claim 16 (depends on 13)

The method of claim 13, wherein the prebiotic composition is polyherbal comprising equal amounts of Emblica offcinalis, Terminalia chebula and Terminalia belerica.

### Claim 17 (depends on 13)

The method of claim 13, wherein the three bacterial strains are live or dead.

### Claim 18 (depends on 13)

The method of claim 13, wherein each of the three bacterial strains is present at 1×105 CFU/ml to 1011 CFU/ml of the formulation, or between 105 CFU/gm and 3.0×1011 CFU/gm of the formulation.

### Claim 19 (depends on 13)

The method of claim 13, wherein the total of the three bacterial strains present is 3.0×109 CFU/ml or 3.0×109 CFU/gm of the formulation.

### Claim 20 (depends on 13)

The method of claim 13, wherein each of the three bacterial strains is present at about 1.0×109 CFU/ml.

### Claim 21 (depends on 13)

The method of claim 13, wherein the individual is a human or an animal.

### Claim 22 (depends on 13)

The method of claim 13, wherein the formulation is in the form of a solution, a suspension, an emulsion, a powder, a lozenge, a pill, a syrup, a tablet, a capsule, a geltab, an aerosol, a suppository, a chewing gum, a capsule or a sachet.

### Claim 23 (depends on 13)

The method of claim 13, wherein the formulation is administered in an edible material, a drink, or a foodstuff.

### Claim 24 (depends on 13)

The method of claim 13, wherein the formulation is administered in a fluid or solid dairy product, milk or condensed milk, drinkable yogurt, yogurt, fermented beverage, ice cream, cheese, soy milk, vegetable juice, fruit juice, sports drink, dessert, jelly, candy, baby food, health food, dietary supplement, or dietary additive.