# US 10,501,530 B2 · Probiotics, secretory IgA and inflammation

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- Number: US 10,501,530 B2
- Document ID: US10501530B2
- Status: Granted
- Kind: B2
- Application number: 15/787,904
- Filed: 2017-10-19
- Published: 2018-02-08
- Granted: 2019-12-10
- Earliest claimed: 2008-06-24
- Assignees: Societe des Produits Nestle S.A.
- Applicants: Nestec S.A.
- Inventors: Jalil Benyacoub; Blaise Corthesy; Stephanie Blum-Sperisen; Laurent Favre
- Web page: https://patentgrep.com/patent/US10501530B2

## CPC

- C07K 16/1228: Enterobacterales (O), e.g. Citrobacter (G), Serratia (G), Proteus (G), Providencia (G), Morganella (G) or Yersinia (G)
- A61K 35/744: Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
- A61K 35/745: Bifidobacteria
- A61K 35/747: Lactobacilli, e.g. L. acidophilus or L. brevis
- A61P 1/14: Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 37/02: Immunomodulators
- A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61K 2039/505: {comprising antibodies}
- A61K 2039/6037: {Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]}
- A61K 2123/00: Preparations for testing in vivo
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- 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

Probiotics and ways to increase their effectiveness are provided. One embodiment of the present invention relates to a combination of probiotics with SIgA and possible uses of this combination. For example a use of a composition comprising SIgA and at least one probiotic for the preparation of a product to treat or prevent inflammation is disclosed.

## Claims

### Claim 1

A method for reducing the severity of an inflammatory condition selected from the group consisting of inflammatory bowel disease, Crohn's disease, ulcerative colitis, necrotizing enterocolitis, eczema, allergy, and atopy, the method comprising:
administering a therapeutically-effective amount of a composition comprising isolated secretory immunoglobulin A (SIgA) and a probiotic micro-organism to a subject, wherein the isolated SIgA and the probiotic micro-organism are present in the form of a complex with each other, the isolated SIgA and the probiotic micro-organism are present in the composition in a stoichiometric ratio of a least 10:1, and the composition comprises between 102 and 2×107 cells of the probiotic micro-organism per daily dose.

### Claim 2 (depends on 1)

The method of claim 1, wherein the subject is selected from the group consisting of newborns, infants, juveniles, adults, elderly, and mothers during pregnancy or lactation.

### Claim 3 (depends on 1)

The method of claim 1, wherein the composition comprises milk obtained from an animal or plant source.

### Claim 4 (depends on 3)

The method of claim 3, wherein the milk is selected from the group consisting of cows' milk, human milk, sheep milk, goat milk, horse milk, camel milk, rice milk, and soy milk.

### Claim 5 (depends on 1)

The method of claim 1, wherein the composition comprises milk protein fractions or colostrum.

### Claim 6 (depends on 1)

The method of claim 1, wherein the composition contains a prebiotic.

### Claim 7 (depends on 6)

The method of claim 6, wherein the prebiotic is selected from the group consisting of oligosaccharides, dietary fibers, and mixtures thereof.

### Claim 8 (depends on 6)

The method of claim 6, wherein the prebiotic is selected from the group consisting of fructo-oligosaccharides (FOS), galacto-oligosaccharides (GOS), isomalto-oligosaccharides, xylo-oligosaccharides, oligosaccharides of soy, glycosyl sucrose (GS), lactosucrose (LS), lactulose (LA), palatinose-oligosaccharides (PAO), maltooligosaccharides, pectins, hydrolysates thereof, and mixtures thereof.

### Claim 9 (depends on 1)

The method of claim 1, wherein the composition comprises between 102 and 1010 cells of the probiotic micro-organism per daily dose.

### Claim 10 (depends on 1)

The method of claim 1, wherein the composition comprises between 0.0001 mg SIgA and 10 mg SIgA per daily dose.

### Claim 11 (depends on 1)

The method of claim 1, wherein the probiotic micro-organism is selected from the group consisting of Bifidobacterium, Lactobacillus, Streptococcus, Saccharomyces, and mixtures thereof.

### Claim 12 (depends on 1)

The method of claim 1, wherein the probiotic micro-organism is selected from the group consisting of Bifidobacterium longum, Bifidobacterium lactis, Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus paracasei, Lactobacillus johnsonii, Lactobacillus plantarum, Lactobacillus salivarius, Enterococcus faecium, Saccharomyces boulardii and Lactobacillus reuteri, and mixtures thereof.

### Claim 13 (depends on 1)

The method of claim 1, wherein the probiotic micro-organism is selected from the group consisting of Lactobacillus johnsonii (NCC533; CNCM I-1225), Bifidobacterium longum (NCC490; CNCM I-2170), Bifidobacterium longum (NCC2705; CNCM I-2618), Bifidobacterium lactis (2818; CNCM I-3446), Lactobacillus paracasei (NCC2461: CNCM 1-2116), Lactobacillus rhamnosus GG (ATCC53103), Lactobacillus rhamnosus (NCC4007; CGMCC 1.3724), Enterococcus faecium SF 68 (NCIMB10415), and mixtures thereof.

### Claim 14 (depends on 1)

The method of claim 1, wherein at least 90% of the probiotic micro-organism present in the composition is associated with at least one isolated SIgA molecule as immune complexes.

### Claim 15 (depends on 1)

The method of claim 1, wherein the isolated SIgA and the probiotic micro-organism are present in the composition in a stoichiometric ratio of at least 100:1.