# US 11,298,384 B2 · Composition for use in the treatment of major depressive disorder

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- Number: US 11,298,384 B2
- Document ID: US11298384B2
- Status: Granted
- Kind: B2
- Application number: 16/321,405
- Filed: 2017-08-10
- Published: 2021-09-09
- Granted: 2022-04-12
- Earliest claimed: 2016-08-10
- Assignees: Probiotical S.P.A.
- Applicants: Probiotical S.P.A.
- Inventors: Giovanni Mogna
- Web page: https://patentgrep.com/patent/US11298384B2

## CPC

- A61K 35/741: Probiotics (probiotic yeast, e.g. saccharomyces A61K36/06)
- A61K 35/747: Lactobacilli, e.g. L. acidophilus or L. brevis
- A61K 31/122: having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
- 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 31/205: Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
- A61K 31/355: Tocopherols, e.g. vitamin E
- A61K 31/519: ortho- or peri-condensed with heterocyclic rings
- A61K 31/59: Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
- A61K 31/593: 9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
- A61K 33/04: Sulfur, selenium or tellurium; Compounds thereof
- A61K 33/06: Aluminium, calcium or magnesium; Compounds thereof {, e.g. clay}
- A61K 33/30: Zinc; Compounds thereof
- A61K 35/745: Bifidobacteria
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 25/24: Antidepressants
- 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

## Abstract

This invention relates to a composition for use in the treatment of major depressive disorder. In addition, this invention relates to a composition for use in the treatment and/or improvement of mood disturbances and for use in the treatment and/or improvement of the mood state.

## Claims

### Claim 1

A method for the treatment and/or improvement of a major depressive disorder, of a mood disorder or of the mood state of a subject in need thereof, comprising orally administering to the subject a composition comprising a therapeutically effective amount of a mixture of bacterial strains to the subject, wherein the mixture comprises:
Lactobacillus fermentum strain LF16 DSM 26956;
Lactobacillus plantarum strain LP01 LMG P-21021 and/or strain LP02 LMG P-21020;
Lactobacillus rhamnosus strain LR06 DSM 21981; and
Bifidobacterium longum strain BL04 DSM 23233.

### Claim 2 (depends on 1)

The method of claim 1, wherein said composition further comprises:
(a) at least one vitamin;
(b) at least one salt; and/or
(c) an antioxidant, an additive, a pharmaceutical excipient and/or a food grade excipient.

### Claim 3 (depends on 1)

The method of claim 1, wherein each strain is present in the composition at a concentration in the range of 1×108 CFU to 1×1012 CFU.

### Claim 4 (depends on 2)

The method of claim 2, wherein said at least one vitamin is chosen from the group consisting of C group vitamins, E group vitamins, B group vitamins and D group vitamins, or a combination thereof.

### Claim 5 (depends on 2)

The method of claim 2, wherein said at least one salt is chosen from the group consisting of organic and inorganic salts of magnesium, selenium, and of zinc.

### Claim 6 (depends on 5)

The method of claim 5, wherein the salt is chosen from the group consisting of magnesium glycinate, selenium methionine and zinc gluconate.

### Claim 7 (depends on 2)

The method of claim 2, wherein said antioxidant is chosen from the group consisting of N-acetyl cysteine (NAC), Coenzyme Q10 (CoQ10); and L-Acetylcarnitine ALC.

### Claim 8 (depends on 1)

The method of claim 1, wherein said mixture consists of:
Lactobacillus fermentum strain LF16 DSM 26956;
Lactobacillus plantarum strain LP01 LMG P-21021 and/or strain LP02 LMG P-21020;
Lactobacillus rhamnosus LR06 DSM 21981; and
Bifidobacterium longum BL04 DSM 23233.

### Claim 9 (depends on 1)

The method of claim 1, wherein said mixture further comprises of maltodextrin.

### Claim 10 (depends on 1)

The method of claim 1, wherein said bacteria strains are lyophilised.