# US 10,369,175 B2 · Probiotic recolonisation therapy

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- Number: US 10,369,175 B2
- Document ID: US10369175B2
- Status: Granted
- Kind: B2
- Application number: 16/028,325
- Filed: 2018-07-05
- Published: 2018-12-06
- Granted: 2019-08-06
- Earliest claimed: 2000-07-25
- Assignees: Crestovo Holdings LLC
- Applicants: Crestovo Holdings LLC
- Inventors: Thomas Julius Borody
- Web page: https://patentgrep.com/patent/US10369175B2

## CPC

- A61K 35/742: Spore-forming bacteria, e.g. Bacillus coagulans, Bacillus subtilis, clostridium or Lactobacillus sporogenes
- A23C 9/123: using only microorganisms of the genus lactobacteriaceae; Yoghurt (A23C9/13 takes precedence)
- A23C 9/127: using microorganisms of the genus lactobacteriaceae and other microorganisms or enzymes, e.g. kefir, koumiss (A23C9/13 takes precedence)
- A23C 9/13: using additives
- A23L 2/52: Adding ingredients (adding preservatives A23B70/10)
- A23L 33/135: Bacteria or derivatives thereof, e.g. probiotics
- A61K 9/0031: {Rectum, anus}
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/19: lyophilised {, i.e. freeze-dried, solutions or dispersions (lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00)}
- A61K 9/48: Preparations in capsules, e.g. of gelatin, of chocolate {(A61K9/0004 takes precedence; bite capsules A61K9/0056)}
- A61K 9/4891: {Coated capsules; Multilayered drug free capsule shells (with drug coating for immediate release A61K9/4808; osmotic devices A61K9/0004)}
- A61K 9/50: Microcapsules {having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals (A61K9/2081 takes precedence; particles with a single coating comprising drug A61K9/167)}
- A61K 9/5005: {Wall or coating material}
- A61K 31/341: not condensed with another ring, e.g. ranitidine, furosemide, bufetolol, muscarine
- A61K 31/41: having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K 31/495: having six-membered rings with two {or more} nitrogen atoms as the only ring heteroatoms, e.g. piperazine {or tetrazines}(A61K31/48 takes precedence {; with three nitrogen atoms A61K31/53})
- A61K 31/7034: attached to a carbocyclic compound, e.g. phloridzin
- A61K 35/24: Mucus; Mucous glands; Bursa; Synovial fluid; Arthral fluid; Excreta; Spinal fluid (saliva A61K35/38)
- A61K 35/37: Digestive system
- A61K 35/38: Stomach; Intestine; Goblet cells; Oral mucosa; Saliva
- A61K 35/74: Bacteria (therapeutic use of a bacterial protein A61K38/00)
- A61K 35/741: Probiotics (probiotic yeast, e.g. saccharomyces A61K36/06)
- 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
- A61K 36/062: Ascomycota
- A61K 38/14: Peptides containing saccharide radicals; Derivatives thereof {, e.g. bleomycin, phleomycin, muramylpeptides or vancomycin}
- A61K 38/4893: {Botulinum neurotoxin (3.4.24.69)}
- 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 1/12: Antidiarrhoeals
- A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs
- A61K 9/5078: {with drug-free core}
- A61K 31/43: Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula [IMAGE cpc-sch-A61K-0952.gif], e.g. penicillins, penems
- A61K 31/545: Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula: [IMAGE cpc-sch-A61K-0953.gif] , e.g. cephalosporins, {cefaclor, or cephalexine}
- A61K 31/7048: having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin {, digitoxin or digoxin}
- A61K 35/76: Viruses; Subviral particles; Bacteriophages
- A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00)
- A61K 39/00: Medicinal preparations containing antigens or antibodies (materials for immunoassay G01N33/53)
- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61K 51/1217: {Dispersions, suspensions, colloids, emulsions, e.g. perfluorinated emulsion, sols}
- A61K 2035/115: {Probiotics}
- C12N 2795/00032: Use of virus as therapeutic agent, other than vaccine, e.g. as cytolytic agent
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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)
- A23C: DAIRY PRODUCTS, e.g. MILK, BUTTER OR CHEESE; MILK OR CHEESE SUBSTITUTES; PREPARATION THEREOF (preservation thereof A23B11/00)
- 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
- A23V: INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The present invention relates to pharmaceutical compositions suitable for the treatment of chronic diseases associated with the presence of abnormal or an abnormal distribution of microflora in the gastrointestinal tract of a mammalian host, which compositions comprise viable non-pathogenic or attenuated pathogenic Clostridia. The compositions further comprise one or more additional viable non-pathogenic or attenuated pathogenic microorganisms selected from the group consisting of Bacteroides, Eubacteria, Fusobacteria, Propionibacteria, Lactobacilli, anaerobic cocci, Ruminococcus, E. coli, Gemmiger, Desulfomonas, Peptostreptococcus, and fungi. The present invention also provides pharmaceutical compositions suitable for the treatment of the same chronic diseases comprising viable non-pathogenic or attenuated pathogenic Escherichia coli, at least one strain of viable non-pathogenic or attenuated pathogenic Bacteroides and at least one strain of viable non-pathogenic or attenuated pathogenic microorganism.

## Claims

### Claim 1

A pharmaceutical composition comprising a purified bacterial mixture of at least two viable bacterial strains selected from the group consisting of Clostridium leptum, Clostridium clostridioforme, Clostridium indolis, Clostridium oroticum, Clostridium scindens, Clostridium sphenoides, and Clostridium symbiosum, wherein the bacterial strains are isolated from a human, wherein the pharmaceutical composition is formulated for delivery to the intestine, and wherein the pharmaceutical composition does not include Bacteroides.

### Claim 2 (depends on 1)

The pharmaceutical composition of claim 1, wherein said pharmaceutical composition further does not include Lactobacillus or Bifidobacterium.

### Claim 3 (depends on 1)

The pharmaceutical composition of claim 1, wherein said pharmaceutical composition is in a capsule.

### Claim 4 (depends on 1)

The pharmaceutical composition of claim 1, wherein said pharmaceutical composition is formulated for delivery to the colon.

### Claim 5 (depends on 1)

The pharmaceutical composition of claim 1, wherein said pharmaceutical composition is formulated for oral administration.

### Claim 6 (depends on 1)

The pharmaceutical composition of claim 1, wherein said at least two viable bacterial strains are in a spore form.

### Claim 7 (depends on 1)

The pharmaceutical composition of claim 1, wherein said pharmaceutical composition comprises Clostridium scindens.

### Claim 8 (depends on 1)

The pharmaceutical composition of claim 1, wherein said pharmaceutical composition comprises between about 107 and about 109 viable microbes or between about 109 and about 1011 viable microbes.

### Claim 9 (depends on 1)

The pharmaceutical composition of claim 1, wherein said pharmaceutical composition is effective for treating inflammatory bowel disease.

### Claim 10 (depends on 1)

The pharmaceutical composition of claim 1, wherein said pharmaceutical composition is effective for treating Crohn's disease.

### Claim 11 (depends on 1)

The pharmaceutical composition of claim 1, wherein said pharmaceutical composition is effective for treating ulcerative colitis.

### Claim 12

A pharmaceutical composition comprising a purified bacterial mixture of at least two viable bacterial strains selected from the group consisting of Clostridium indolis, Clostridium scindens, Clostridium symbiosum, and Blautia producta, wherein said pharmaceutical composition is formulated for delivery to the intestine, and wherein said pharmaceutical composition does not include Bacteroides.

### Claim 13 (depends on 12)

The pharmaceutical composition of claim 12, wherein said purified bacterial mixture comprises all four bacterial strains of Clostridium indolis, Clostridium scindens, Clostridium symbiosum, and Blautia producta.

### Claim 14 (depends on 13)

The pharmaceutical composition of claim 13, wherein said pharmaceutical composition is in a capsule.

### Claim 15 (depends on 13)

The pharmaceutical composition of claim 13, wherein said pharmaceutical composition is in an enteric coated capsule.

### Claim 16 (depends on 12)

The pharmaceutical composition of claim 12, wherein said pharmaceutical composition comprises Clostridium scindens.

### Claim 17 (depends on 12)

The pharmaceutical composition of claim 12, wherein said at least two viable bacterial strains are in a spore form.

### Claim 18 (depends on 12)

The pharmaceutical composition of claim 12, wherein said pharmaceutical composition does not include Lactobacillus or Bifidobacterium.

### Claim 19 (depends on 12)

The pharmaceutical composition of claim 12, wherein said pharmaceutical composition comprises between about 107 and about 109 viable microbes or between about 109 and about 1011 viable microbes.

### Claim 20 (depends on 12)

The pharmaceutical composition of claim 12, wherein said pharmaceutical composition is effective for treating inflammatory bowel disease.

### Claim 21 (depends on 12)

The pharmaceutical composition of claim 12, wherein said pharmaceutical composition is effective for treating Crohn's disease.

### Claim 22 (depends on 12)

The pharmaceutical composition of claim 12, wherein said pharmaceutical composition is effective for treating ulcerative colitis.