# US 11,998,578 B2 · Composition for use in the treatment and/or improvement of sleep and mood disorders

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- Number: US 11,998,578 B2
- Document ID: US11998578B2
- Status: Granted
- Kind: B2
- Application number: 17/879,700
- Filed: 2022-08-02
- Published: 2022-11-17
- Granted: 2024-06-04
- Earliest claimed: 2017-12-19
- Assignees: Probiotical S.P.A.
- Applicants: Probiotical S.P.A.
- Inventors: Marco Pane; Angela Amoruso; Mirta Fiorio; Angela Marotta; Giovanna Felis; Antonio Del Casale
- Web page: https://patentgrep.com/patent/US11998578B2

## CPC

- A61K 35/744: Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
- A61K 35/747: Lactobacilli, e.g. L. acidophilus or L. brevis
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K 35/741: Probiotics (probiotic yeast, e.g. saccharomyces A61K36/06)
- A61K 35/745: Bifidobacteria
- A61P 25/00: Drugs for disorders of the nervous system
- 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

The present invention refers to a composition for use in the treatment of sleep disorder, in particular, in the improvement of sleep quality. Furthermore, the present invention refers to a composition for use in the treatment of mood modulation.

## Claims

### Claim 1

A composition comprising:
a mixture of bacteria strains, comprising:
(a) a bacterium strain of the Lactobacillus fermentum species identified as Lactobacillus fermentum LF16 DSM 26956,
(b) a bacterium strain of the Lactobacillus plantarum species identified as Lactobacillus plantarum LP01 LMG P-21021, and/or a bacterium strain of the Lactobacillus plantarum species identified as Lactobacillus plantarum LP02 LMG P-21020,
(c) a bacterium strain of the Lactobacillus rhamnosus species identified as Lactobacillus rhamnosus LR06 DSM 21981; and
(d) a bacterium strain of the Bifidobacterium longum species identified as Bifidobacterium longum BL04 DSM 23233.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the composition further comprises at least one pharmaceutical or food grade excipient.

### Claim 3 (depends on 1)

The composition of claim 1, wherein the bacterial strains are at a concentration of between 1×108 CFU (Colony forming units) and 1×1012 CFU.

### Claim 4 (depends on 1)

The composition of claim 1, wherein said composition further comprises:
at least one natural vegetable gum and/or S. thermophilus bacteria strain ST10 DSM 25246.

### Claim 5

A composition comprising:
a mixture of bacteria strains, comprising:
(a) a bacterium strain of the Lactobacillus fermentum species identified as Lactobacillus fermentum LF16 DSM 26956,
(b) a bacterium strain of the Lactobacillus plantarum species identified as Lactobacillus plantarum LP01 LMG P-21021, and/or a bacterium strain of the Lactobacillus plantarum species identified as Lactobacillus plantarum LP02 LMG P-21020,
(c) a bacterium strain of the Lactobacillus rhamnosus species identified as Lactobacillus rhamnosus LR06 DSM 21981; and
(d) a bacterium strain of the Bifidobacterium longum species identified as Bifidobacterium longum BL04 DSM 23233, and wherein said composition further comprises vitamin B, C, D and/or E.

### Claim 6 (depends on 1)

The composition of claim 1, wherein said composition further comprises at least one salt selected from organic and inorganic salts of magnesium, selenium, and zinc.

### Claim 7 (depends on 1)

The composition of claim 1, wherein said composition further comprises is magnesium glycinate, selenium methionine and/or zinc gluconate.

### Claim 8 (depends on 1)

The composition of claim 1, wherein the composition further comprises N-acetyl cysteine (NAC), coenzyme Q10 (CoQ10), acetyl-L-carnitine (ALC) or any combination thereof.