Methods for treatment of Clostridium difficile infection or recurrence or symptoms thereof

Patent metadata

Field	Value
Publication number	US-11730775-B2
Application number	US-202117222778-A
Country	US
Kind code	B2
Filing date	Apr 5, 2021
Priority date	Feb 4, 2013
Publication date	Aug 22, 2023
Grant date	Aug 22, 2023

Abstract

Disclosed herein are therapeutic compositions containing non-pathogenic, germination-competent bacterial spores, for the prevention, control, and treatment of gastrointestinal diseases, disorders and conditions and for general nutritional health.

First claim

What is claimed is:

1. A method of treating Clostridium difficile infection (CDI) or a symptom thereof in a subject in need thereof, comprising administering a therapeutic composition to the subject in an amount effective to treat the CDI or a symptom thereof,
wherein the therapeutic composition is formulated for oral administration, and comprises:
a purified population of bacteria, and
a capsule; and

wherein the purified population of bacteria consists of spore-forming bacteria in the form of spores.

2. The method of claim 1 , wherein at least one type of spore-forming bacteria in the composition is not detectably present in the gastrointestinal tract of the subject prior to administration of the composition to the subject.

3. The method of claim 1 , wherein administering the composition results in augmenting growth of at least one type of bacteria not detectably present in the composition or in the gastrointestinal tract prior to administration.

4. The method of claim 1 , wherein administering the composition results in at least two of: i) reduction or elimination of at least one pathogen and/or pathobiont present in the gastrointestinal tract of the subject; ii) engraftment in the gastrointestinal tract of the subject of at least one type of spore-forming bacteria present in the composition; and iii) augmentation of at least one type of spore-forming or non-spore forming bacteria in the gastrointestinal tract of the subject that is not present in the composition.

5. The method of claim 1 , wherein the subject has received one or more doses of an antibiotic therapy.

6. The method of claim 1 , wherein the subject is an adult.

7. The method of claim 1 , wherein the therapeutic composition is administered 1 day, 2 days, or 3 days after completing treatment with an antibiotic.

8. The method of claim 1 , wherein the therapeutic composition comprises about 1×10 4 to about 1×10 15 spore colony-forming units of the spore-forming bacteria per dose of the therapeutic composition.

9. The method of claim 8 , wherein the therapeutic composition comprises about 1×10 1 , about 1×10 5 , about 1×10 6 , about 1×10 7 , about 1×10 8 , about 1×10 9 about 1×10 10 , about 1×10 11 , about 1×10 12 , about 1×10 13 , about 1×10 14 , or about 1×10 15 spore colony-forming units of the spore-forming bacteria per dose of the therapeutic composition.

10. The method of claim 1 , wherein antibiotics are not administered concurrently with the therapeutic composition.

11. The method of claim 1 , wherein the therapeutic composition further comprises glycerol.

12. The method of claim 1 , wherein the therapeutic composition further comprises saline.

13. The method of claim 1 , wherein the therapeutic composition is administered once daily.

14. The method of claim 1 , wherein the therapeutic composition is administered on an empty stomach.

15. The method of claim 1 , wherein the therapeutic composition is administered for 3 days.

16. The method of claim 1 , wherein the subject undergoes a colon-cleansing preparation prior to administration of the therapeutic composition.

17. A method of reducing recurrence of Clostridium difficile infection (CDI) or a symptom thereof in a subject in need thereof, comprising administering a therapeutic composition to the subject in an amount effective to reduce recurrence of the CDI or a symptom thereof,
wherein the therapeutic composition is formulated for oral administration, and comprises:
a purified population of bacteria, and
a capsule; and

wherein the purified population of bacteria consists of spore-forming bacteria in the form of spores.

18. The method of claim 17 , wherein at least one type of spore-forming bacteria in the composition is not detectably present in the gastrointestinal tract of the subject prior to administration of the composition to the subject.

19. The method of claim 17 , wherein administering the composition results in augmenting growth of at least one type of bacteria not detectably present in the composition or in the gastrointestinal tract prior to administration.

20. The method of claim 17 , wherein administering the composition results in at least two of: i) reduction or elimination of at least one pathogen and/or pathobiont present in the gastrointestinal tract of the subject; ii) engraftment in the gastrointestinal tract of the subject of at least one type of spore-forming bacteria present in the composition; and iii) augmentation of at least one type of spore-forming or non-spore forming bacteria in the gastrointestinal tract of the subject that is not present in the composition.

21. The method of claim 17 , wherein the subject has received one or more doses of an antibiotic therapy.

22. The method of claim 17 , wherein the subject is an adult.

23. The method of claim 17 , wherein the therapeutic composition is administered 1 day, 2 days, or 3 days after completing treatment with an antibiotic.

24. The method of claim 17 , wherein the therapeutic composition comprises about 1×10 4 to about 1×10 15 spore colony-forming units of the spore-forming bacteria per dose of the therapeutic composition.

25. The method of claim 24 , wherein the therapeutic composition comprises about 1×10 1 , about 1×10 5 , about 1×10 6 , about 1×10 7 , about 1×10 8 , about 1×10 9 , about 1×10 10 , about 1×10 11 , about 1×10 12 , about 1×10 13 , about 1×10 14 , or about 1×10 15 spore colony-forming units of the spore-forming bacteria per dose of the therapeutic composition.

26. The method of claim 17 , wherein antibiotics are not administered concurrently with the therapeutic composition.

27. The method of claim 17 , wherein the therapeutic composition further comprises glycerol.

28. The method of claim 17 , wherein the therapeutic composition further comprises saline.

29. The method of claim 17 , wherein the therapeutic composition is administered once daily.

30. The method of claim 17 , wherein the therapeutic composition is administered on an empty stomach.

31. The method of claim 17 , wherein the therapeutic composition is administered for 3 days.

32. The method of claim 17 , wherein the subject undergoes a colon-cleansing preparation prior to administration of the therapeutic composition.

Assignees

• Seres Therapeutics Inc

Inventors

• Mckenzie Gregory
• Lombardo McKenzie Mary-Jane
• Cook David N
• Vulic Marin
• Von Maltzahn Geoffrey
• Goodman Brian
• Aunins John Grant
• Henn Matthew R
• Berry David Arthur
• Winkler Jonathan

Classifications

• C12N1/20

  Bacteria; Culture media therefor · CPC title

• A61K35/747

  Lactobacilli, e.g. L. acidophilus or L. brevis · CPC title

• A61K35/745

  Bifidobacteria · CPC title

• A61K35/744

  Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs · CPC title

• A61K35/742 Primary

  Spore-forming bacteria, e.g. Bacillus coagulans, Bacillus subtilis, clostridium or Lactobacillus sporogenes · CPC title