IP Library Granted Patent US 8,460,648
Granted Patent B2
US 8,460,648 · App. 10/332,986 · Granted Jun 11, 2013

Probiotic recolonisation therapy

Inventor: Thomas Julius Borody (Five Dock, AU)
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Quick Facts
Patent No.
US 8,460,648
App. No.
10/332,986
Granted
Jun 11, 2013
Kind
B2
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, Desullomonas, 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 pathoenic Bacteroides and at least one strain of viable non-pathogenic or attenuated pathogenic microorganism.

Claims (29)

1. A method for the treatment of a chronic disorder associated with the presence of an abnormal or an abnormal distribution of microflora in the gastrointestinal tract of a mammalian host, the chronic disorder selected from the group consisting of:

irritable bowel syndrome, chronic persistent diarrhoea, diarrhoea, flatulence, constipation, and alternating constipation/diarrhoea, which method comprises administering an effective amount of a composition comprising viable non-pathogenic or attenuated pathogenic microorganisms for a period of time sufficient to displace the existing microflora, wherein the composition comprises:

at least two Clostridia selected from among Clostridium bifermentans, Clostridium butyricum and Clostridium innocuum;

at least one Bacteroides selected from among Bacteroides fragilis, Bacteroides thetaiotaomicron and Bacteroides uniformis ; and

Escherichia coli ; and

wherein lavage or other methods of removal of at least part of the host's existing enteric microflora is omitted.

2. A method according to claim 1 , further comprising administering Peptostreptococcus productus.

3. A method according to claim 1 , further comprising administering one or more additional viable non-pathogenic or attenuated pathogenic microorganisms selected from the group consisting of Bacteroides fragilis ss. vulatus, Eubacterium aerofaciens, Bacteroides fragilis ss. thetaiotaomicron, Peptostreptococcus productus, Bacteroides fragilis ss. distasonis, Fusobacterium prausnitzii, Coprococcus eutactus, Eubacterium aerofaciens, Peptostreptococcus productus, Ruminococcus bromii, Bifidobacterium adolescentis, Gemmiger formicilis, Bifidobacterium longum, Eubacterium siraeum, Ruminococcus torques, Eubacterium rectale, Eubacterium eligens, Bacteroides eggerthii, Clostridium leptum, Eubacterium biforme, Bifidobacterium infantis, Coprococcus comes, Bacteroides capillosus, Ruminococcus albus, Eubacterium formicigenerans, Eubacterium hallii, Eubacterium ventriosum, Fusobacterium russi, Ruminococcus obeum, Clostridium ramosum, Lactobacillus leichmannii, Ruminococcus callidus, Butyrivibrio crossotus, Acidaminococccus fermentans, Eubacterium ventriosum, Bacteroides fragilis ss. fragilis, Coprococcus catus, Eubacterium hadrum, Eubacterium cylindroides, Eubacterium ruminantium, Staphylococcus epidermidis, Eubacterium limosum, Bacteroides praeacutus, Fusobacterium mortiferum, Fusobacterium naviforme, Clostridium innocuum, Propionibacterium acnes, Ruminococcus flavefaciens, Bacteroides fragilis ss. ovatus, Fusobacterium nucleatum, Fusobacterium mortiferum, Escherichia coli, Streptococcus morbiliorum, Peptococcus magnus, Streptococcus intermedius, Ruminococcus lactaris, Eubacterium tenue, Eubacterium ramulus, Bacteroides clostridiiformis ss. clostridliformis, Bacteroides coagulans, Bacteroides oralis, Bacteroides ruminicola ss. brevis, Bacteroides ruminicola ss. ruminicola, Bacteroides splanchnicus or Desuifomonas pigra.

4. A method according to claim 1 , further comprising administering fungi.

5. A method according to claim 4 , wherein the fungi are Monilia.

6. The method according to claim 1 , further comprising administering at least one strain of viable non-pathogenic or attenuated pathogenic Bifidobacterium.

7. A method according to claim 1 , further comprising administering one or more additional agents selected from the group consisting of an acid suppressant, an antacid, an H2 antagonist, a proton pump inhibitor.

8. The method according to claim 1 , wherein said microorganisms are spores.

9. The method according to claim 1 , wherein the composition is lyophilised, pulverised and powdered or a liquid culture.

10. The method according to claim 1 , wherein the composition is administered in a form selected from the group consisting of an enteric coated capsule, an enteric coated microcapsule, a reconstituted powder, an enema, a food, a drink.

11. The method according to claim 10 , wherein said food is selected from the group consisting of yogurt, a dairy-based product, a soy-based product, or a derivative thereof.

12. The method according to claim 1 , wherein the mammalian host is human.

13. The method according to claim 1 , wherein administration is by one or more route(s) selected from the group consisting of ingestion, parenteral infusion, enema, per-colonoscope, intubation of the small bowel or orally.

14. The method according to claim 1 , wherein the chronic disorder is a gastrointestinal disorder.

15. The method according to claim 1 , further comprising an initial treatment regimen of about 10 10 cells per dose administered 3 to 6 times per day for a period sufficient to stabilise the gut flora.

16. The method according to claim 1 , wherein said composition comprises viable non-pathogenic or attenuated pathogenic Clostridia and at least one additional bacterial species.

17. The method according to claim 1 , wherein said Clostridia is Clostridium innocuum.

18. A method according to claim 1 wherein the irritable bowel syndrome is associated with autism.

19. A method for treatment of a chronic disorder associated with the presence of an abnormal or an abnormal distribution of microflora in the gastrointestinal tract of a mammalian host, the chronic disorder selected from the group consisting of:

irritable bowel syndrome, chronic persistent diarrhea, diarrhea, flatulence, constipation, and alternating constipation/diarrhea, which method comprises administering an effective amount of a composition comprising viable non-pathogenic or attenuated pathogenic microorganisms for a period of time sufficient to displace the existing microflora, wherein the composition comprises:

Clostridium bifermentans, clostridium butyricum and Clostridium innocuum;

Bacteroides fragilis, Bacteriodies thetaiotaomicron and Bacteroides uniformis ; and

Escherichia coli;

and wherein lavage or other methods of removal of at least part of the host's existing enteric microflora is omitted.

Assignments (5)
CHANGE OF NAME Recorded Dec 31, 2020
From: CRESTOVO HOLDINGS LLC
To: FINCH THERAPEUTICS HOLDINGS LLC
Reel/Frame 054883/0280 →
RELEASE OF SECURITY INTEREST Recorded Sep 5, 2019
From: CRESTOVO INVESTOR LLC; M3 VENTURES - FINCH II LLC; AVENIR FINCH INVESTORS LLC; FLIGHT PARTNERS MANAGEMENT LLC; NATIONAL PHILANTHROPIC TRUST; 91313 INVESTMENT HOLDING I LLC; SILAS HOLDING I LLC; BEE HILL HOLDINGS LLC; GORMAN, DYLAN; CHOI, KENNETH S.
To: CRESTOVO HOLDINGS LLC
Reel/Frame 050274/0530 →
SECURITY INTEREST Recorded Mar 7, 2019
From: CRESTOVO HOLDINGS LLC
To: CRESTOVO INVESTOR LLC; M3 VENTURES - FINCH II LLC; AVENIR FINCH INVESTORS, LLC; FLIGHT PARTNERS MANAGEMENT LLC; NATIONAL PHILANTHROPIC TRUST; 91313 INVESTMENT HOLDINGS LLC; SILAS HOLDINGS LLC; BEE HILL HOLDINGS LLC; GORMAN, DYLAN; CHOI, KENNETH S.
Reel/Frame 050111/0166 →
CONFIRMATORY ASSIGNMENT Recorded Aug 15, 2017
From: CRESTOVO LLC
To: CRESTOVO HOLDINGS LLC
Reel/Frame 043550/0821 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 29, 2016
From: BORODY, THOMAS J
To: CRESTOVO LLC
Reel/Frame 037618/0009 →
Priority Claims (1)
AU PQ8997 · Jul 25, 2000 · national
Continuity (1)
Related Publication 20040028689A1 · Feb 12, 2004