# US 10,245,300 B2 · Gluten-related disorders

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- Number: US 10,245,300 B2
- Document ID: US10245300B2
- Status: Granted
- Kind: B2
- Application number: 14/408,108
- Filed: 2013-06-18
- Published: 2015-06-25
- Granted: 2019-04-02
- Earliest claimed: 2012-06-18
- Assignees: H.J. Heinz Company Brands LLC
- Applicants: H.J. Heinz Company Brands LLC
- Inventors: Francesca Romana Fasano; Andrea Luigi Budelli
- Web page: https://patentgrep.com/patent/US10245300B2

## CPC

- A61K 38/164: {from bacteria}
- A23L 33/135: Bacteria or derivatives thereof, e.g. probiotics
- A23L 33/30: {Dietetic or nutritional methods, e.g. for losing weight (A23L33/10 takes precedence)}
- A61K 31/045: Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
- A61K 31/19: Carboxylic acids, e.g. valproic acid (salicylic acid A61K31/60)
- 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 31/401: Proline; Derivatives thereof, e.g. captopril
- A61K 31/4172: Imidazole-alkanecarboxylic acids, e.g. histidine
- A61K 31/708: having oxo groups directly attached to the purine ring system, e.g. guanosine, guanylic acid
- 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 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 19/00: Drugs for skeletal disorders
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 29/02: without antiinflammatory effect
- A61P 37/00: Drugs for immunological or allergic disorders
- C07K 14/335: from Lactobacillus (G)
- A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs
- 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)
- 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
- 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)
- A23V: INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION

## Abstract

The present invention features compositions and methods for treating gluten-related disorders. We describe compositions comprising one or more metabolites produced by Lactobacillus paracasei CBA L74, International Depository Accession Number LMG P-24778 that reduce cellular entry of gliadin peptides. The compositions may include a physiologically acceptable carrier, for example, a food product or a pharmaceutical carrier. The compositions can be administered to a subject having a gluten-related disorder, for example, celiac disease or gluten sensitivity.

## Claims

### Claim 1

A method of treating a subject having a gluten-related disorder, the method comprising:
administering to the subject an effective amount of a composition comprising a probiotic bacterium Lactobacillus paracasei CBA L74, deposited at the Belgian Coordinated Collections of Micro-organisms (BCCM) Laboratorium voor Microbiologie (LMG) and having International Depository Accession Number LMG P-24778, wherein the probiotic bacterium reduces a symptom of gliadin peptide toxicity.

### Claim 2 (depends on 1)

The method of claim 1, wherein the gliadin peptide is an α-gliadin peptide.

### Claim 3 (depends on 2)

The method of claim 2, wherein the α-gliadin peptide has an amino acid sequence selected from the group consisting of LGQQQPFPPQQPY (SEQ ID NO: 1); QLQPFPQPQLPY (SEQ ID NO: 2); LGQQQPFPPQQPYPQPQPF (SEQ ID NO: 3); and LQLQPFPQPQLPYPQPQLPYPQPQLPYPQPQPF (SEQ ID NO: 4).

### Claim 4 (depends on 1)

The method of claim 1, wherein the gluten-related disorder is celiac disease or gluten sensitivity.

### Claim 5 (depends on 1)

The method of claim 1, wherein the symptom of gliadin peptide toxicity comprises at least one of inflammation, an autoimmune reaction, a gastrointestinal symptom, weight loss, anemia, osteoporosis, arthritis, infertility, peripheral neuropathy, and liver failure.

### Claim 6 (depends on 1)

The method of claim 1, further comprising a step of administering a second treatment for the gluten-related disorder.

### Claim 7 (depends on 6)

The method of claim 6, wherein the second treatment is a dietary or pharmaceutical therapy.

### Claim 8 (depends on 7)

The method of claim 7, wherein the dietary therapy is a gluten-free diet.

### Claim 9 (depends on 1)

The method of claim 1, wherein the probiotic bacterium Lactobacillus paracasei CBA L74, International Depository Accession Number LMG P-24778 is non-replicating.

### Claim 10 (depends on 9)

The method of claim 9, wherein the probiotic bacterium Lactobacillus paracasei CBA L74, International Depository Accession Number LMG P-24778 is dead.

### Claim 11 (depends on 1)

The method of claim 1, wherein the composition further comprises a food product or a pharmaceutical carrier.

### Claim 12

A method of treating a subject having a gluten-related disorder, the method comprising:
administering to the subject an effective amount of a composition comprising a fermented food product, wherein the fermented food product has been fermented by probiotic bacterium Lactobacillus paracasei CBA L74, deposited at the Belgian Coordinated Collections of Micro-organisms (BCCM) Laboratorium voor Microbiologie (LMG) and having International Depository Accession Number LMG P-24778, and the fermented food product reduces a symptom of gliadin peptide toxicity.

### Claim 13 (depends on 12)

The method of claim 12, wherein the probiotic bacterium Lactobacillus paracasei CBA L74 in the composition is dead or has been rendered incapable of cell division.

### Claim 14 (depends on 12)

The method of claim 12, wherein the food product is a dairy product or a cereal product.

### Claim 15 (depends on 12)

The method of claim 12, wherein the composition further comprises a pharmaceutical carrier.

### Claim 16 (depends on 12)

The method of claim 12, wherein the gliadin peptide is an α-gliadin peptide.

### Claim 17 (depends on 16)

The method of claim 16, wherein the α-gliadin peptide has an amino acid sequence selected from the group consisting of LGQQQPFPPQQPY (SEQ ID NO: 1); QLQPFPQPQLPY (SEQ ID NO: 2); LGQQQPFPPQQPYPQPQPF (SEQ ID NO: 3); and LQLQPFPQPQLPYPQPQLPYPQPQLPYPQPQPF (SEQ ID NO: 4).

### Claim 18 (depends on 12)

The method of claim 12, wherein the gluten-related disorder is celiac disease or gluten sensitivity.

### Claim 19 (depends on 12)

The method of claim 12, wherein the symptom of gliadin peptide toxicity comprises at least one of inflammation, an autoimmune reaction, a gastrointestinal symptom, weight loss, anemia, osteoporosis, arthritis, infertility, peripheral neuropathy, and liver failure.

### Claim 20 (depends on 12)

The method of claim 12, further comprising a step of administering a second treatment for the gluten-related disorder.

### Claim 21 (depends on 20)

The method of claim 20, wherein the second treatment is a dietary or pharmaceutical therapy.

### Claim 22 (depends on 21)

The method of claim 21, wherein the dietary therapy is a gluten-free diet.

### Claim 23

A method of treating a subject having a gluten-related disorder, the method comprising:
administering to the subject an effective amount of a composition comprising a culture supernatant of probiotic bacterium Lactobacillus paracasei CBA L74, deposited at the Belgian Coordinated Collections of Micro-organisms (BCCM) Laboratorium voor Microbiologie (LMG) and having International Depository Accession Number LMG P-24778, wherein the culture supernatant reduces a symptom of gliadin peptide toxicity in a subject having a gluten-related disorder, and
the culture supernatant comprises Lactobacillus paracasei CBA L74 cells and/or one or more sub-cellular bacterial components from Lactobacillus paracasei CBA L74 cells, wherein any Lactobacillus paracasei CBA L74 cells present in the culture supernatant are dead or have been rendered incapable of cell division.

### Claim 24 (depends on 23)

The method of claim 23, wherein the composition further comprises a food product or a pharmaceutical carrier.

### Claim 25 (depends on 23)

The method of claim 23, wherein the gliadin peptide is an α-gliadin peptide.

### Claim 26 (depends on 25)

The method of claim 25, wherein the α-gliadin peptide has an amino acid sequence selected from the group consisting of LGQQQPFPPQQPY (SEQ ID NO: 1); QLQPFPQPQLPY (SEQ ID NO: 2); LGQQQPFPPQQPYPQPQPF (SEQ ID NO: 3); and LQLQPFPQPQLPYPQPQLPYPQPQLPYPQPQPF (SEQ ID NO: 4).

### Claim 27 (depends on 23)

The method of claim 23, wherein the gluten-related disorder is celiac disease or gluten sensitivity.

### Claim 28 (depends on 23)

The method of claim 23, wherein the symptom of gliadin peptide toxicity comprises at least one of inflammation, an autoimmune reaction, a gastrointestinal symptom, weight loss, anemia, osteoporosis, arthritis, infertility, peripheral neuropathy, and liver failure.

### Claim 29 (depends on 23)

The method of claim 23, further comprising administering a second treatment for the gluten-related disorder.

### Claim 30 (depends on 29)

The method of claim 29, wherein the second treatment is a dietary or pharmaceutical therapy.

### Claim 31 (depends on 30)

The method of claim 30, wherein the dietary therapy is a gluten-free diet.