Compositions and methods

Patent metadata

Field	Value
Publication number	US-10967011-B2
Application number	US-201816054864-A
Country	US
Kind code	B2
Filing date	Aug 3, 2018
Priority date	Feb 4, 2013
Publication date	Apr 6, 2021
Grant date	Apr 6, 2021

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 therapeutic composition formulated for oral administration comprising a purified population of bacteria, an enteric coating, and a capsule, wherein the purified population of bacteria consist of spore-forming bacteria, and wherein at least one of the spore-forming bacteria are selected from the group consisting of Clostridium methylpentosum, Clostridium sp YIT 12069 , Anaerofustis stercorihominis, Bacteroides galacturonicus, Bacteroides pectinophilus, Brachyspira pilosicoli, Clostridium beijerinckii, Clostridium carnis, Clostridium favososporum, Clostridium sp. L2-50, Clostridium sp. MT4 E, Clostridium sp. NML 04A032 , Clostridium sp. SS211 , Clostridium stercorarium, Clostridium xylanolyticum, Coprococcus sp. ART55/1 , Deferribacteres sp. oral clone JV006 , Desuljitobacterium frappieri, Exiguobacterium acetylicum, Lachnospira multipara , and Lachnospira pectinoschiza.

2. The composition of claim 1 , wherein the spore-forming bacteria consists essentially of germinable bacterial spores.

3. The composition of claim 1 , wherein the composition is derived from a fecal material subjected to ethanol treatment or heat treatment.

4. The composition of claim 3 , wherein the composition is derived from fecal material subjected to ethanol treatment.

5. The composition of claim 4 , wherein the composition is derived from fecal material subjected to treatment with 30-90% ethanol.

6. The composition of claim 4 , wherein the composition is derived from fecal material subjected to treatment with 50-70% ethanol.

7. The composition of claim 4 , wherein the composition is derived from fecal material subjected to treatment with 50% ethanol.

8. The composition of claim 4 , wherein the composition augments a titer of one or more non-pathogenic Bacteroides selected from the group consisting of Bacteroides sp. 4_1_36 , Bacteroides cellulosilyticus, Bacteroides sp. 1_1_30 , Bacteroides uniformis, Bacteroides ovatus, Bacteroides dorei, Bacteroides xylanisolvens , and Bacteroides sp. 3_1_19; and
wherein the non-pathogenic Bacteroides titer is augmented in the gastrointestinal tract of the subject.

9. The composition of claim 3 , wherein the fecal material is a 10 to 20% fecal suspension.

10. The composition of claim 3 , wherein the fecal material is obtained from a validated mammalian donor subject not having a detectable level of a pathogen or a pathobiont prior to production of the fecal material.

11. The composition of claim 3 , wherein the fecal material is obtained from a validated mammalian donor subject not having a detectable level of a blood-borne pathogen or a fecal bacterial pathogen prior to production of the fecal material.

12. The composition of claim 1 , wherein the composition comprises at least 10×10 4 colony forming units of the spore-forming bacteria per dose of the composition.

13. The composition of claim 1 , wherein the capsule is a delayed release capsule.

14. The composition of claim 1 , wherein the purified population of bacteria are substantially free of residual habitat products.

15. The composition of claim 14 , wherein the residual habitat product is an abiotic material, a human or animal cell, a virus, a fungus, a mycoplasma , a toxoplasma , an eukaryotic parasite, or a combination thereof.

16. The composition of claim 1 , wherein the composition further comprises an excipient.

17. The composition of claim 16 , wherein the excipient is a germinant.

18. The composition of claim 1 , wherein the purified population of bacteria are lyophilized.

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