Composition for inducing proliferation or accumulation of regulatory T cells

Patent metadata

Field	Value
Publication number	US-9808519-B2
Application number	US-201715590257-A
Country	US
Kind code	B2
Filing date	May 9, 2017
Priority date	Jun 4, 2010
Publication date	Nov 7, 2017
Grant date	Nov 7, 2017

Abstract

It was found that bacteria belonging to the genus Clostridium induce accumulation of regulatory T cells (Treg cells) in the colon. Moreover, the present inventors found that regulatory T cells (Treg cells) induced by from these bacteria suppressed proliferation of effector T-cells. From these findings, the present inventors found that the use of bacteria belonging to the genus Clostridium or a physiologically active substance derived therefrom made it possible to induce proliferation or accumulation of regulatory T cells (Treg cells), and further to suppress immune functions.

First claim

The invention claimed is:

1. A pharmaceutical composition comprising a spore-forming fraction of human fecal matter formulated for delivery to the intestine, wherein the composition induces proliferation and/or accumulation of regulatory T cells, wherein the spore-forming fraction is resistant to chloroform, and wherein the composition is formulated for oral administration.

2. The pharmaceutical composition of claim 1 , wherein the spore-forming fraction is obtained by chloroform treatment of human fecal matter.

3. The pharmaceutical composition of claim 2 , wherein the chloroform treatment includes an incubation step with chloroform of about 1 hour.

4. The pharmaceutical composition of claim 3 , wherein the chloroform treatment includes a step of removal of chloroform with nitrogen gas.

5. The pharmaceutical composition of claim 1 , wherein the composition further comprises a pharmacologically acceptable carrier.

6. The pharmaceutical composition of claim 1 , wherein the composition is in the form of a capsule.

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

8. The pharmaceutical composition of claim 1 , wherein the composition further comprises a pH sensitive composition comprising one or more enteric polymers.

9. A pharmaceutical composition comprising a spore-forming fraction of human fecal matter formulated for delivery to the intestine, wherein the composition induces proliferation and/or accumulation of regulatory T cells, wherein the spore-forming fraction is resistant to heat, and wherein the composition is formulated for oral administration.

10. The pharmaceutical composition of claim 9 , wherein the spore-forming fraction is obtained by chloroform treatment of human fecal matter.

11. The pharmaceutical composition of claim 10 , wherein the chloroform treatment includes an incubation step with chloroform of about 1 hour.

12. The pharmaceutical composition of claim 11 , wherein the chloroform treatment includes a step of removal of chloroform with nitrogen gas.

13. The pharmaceutical composition of claim 9 , wherein the composition further comprises a pharmacologically acceptable carrier.

14. The pharmaceutical composition of claim 9 , wherein the composition is in the form of a capsule.

15. The pharmaceutical composition of claim 9 , wherein the composition is formulated for delivery to the colon.

16. The pharmaceutical composition of claim 9 , wherein the composition further comprises a pH sensitive composition comprising one or more enteric polymers.

17. A pharmaceutical composition comprising an active ingredient, wherein the active ingredient consists of a spore-forming fraction of human fecal matter, wherein the composition is formulated for delivery to the intestine, wherein the composition induces proliferation and/or accumulation of regulatory T cells, and wherein the composition is formulated for oral administration.

18. The pharmaceutical composition of claim 17 , wherein the spore-forming fraction is resistant to chloroform.

19. The pharmaceutical composition of claim 18 , wherein the spore-forming fraction is obtained by chloroform treatment of human fecal matter.

20. The pharmaceutical composition of claim 19 , wherein the chloroform treatment includes an incubation step with chloroform of about 1 hour.

21. The pharmaceutical composition of claim 20 , wherein the chloroform treatment includes a step of removal of chloroform with nitrogen gas.

22. The pharmaceutical composition of claim 17 , wherein the spore-forming fraction is resistant to heat.

23. The pharmaceutical composition of claim 17 , wherein the composition further comprises a pharmacologically acceptable carrier.

24. The pharmaceutical composition of claim 17 , wherein the composition is in the form of a capsule.

25. The pharmaceutical composition of claim 17 , wherein the composition is formulated for delivery to the colon.

26. The pharmaceutical composition of claim 17 , wherein the composition further comprises a pH sensitive composition comprising one or more enteric polymers.

27. The pharmaceutical composition of claim 1 , wherein the composition does not include Bacteroides.

28. The pharmaceutical composition of claim 9 , wherein the composition does not include Bacteroides.

Assignees

• Univ Tokyo

Inventors

• Honda Kenya
• Atarashi Koji
• Itoh Kikuji
• Tanoue Takeshi

Classifications

• A61P37/02

  Immunomodulators · CPC title

• A61P37/06

  Immunosuppressants, e.g. drugs for graft rejection · CPC title

• A61P43/00

  Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 · CPC title

• A61P37/08

  Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14) · CPC title

• A61P37/04

  Immunostimulants · CPC title