Methods of Populating a Gastrointestinal Tract

Patent metadata

Field	Value
Publication number	US-2016158294-A1
Application number	US-201414765810-A
Country	US
Kind code	A1
Filing date	Feb 4, 2014
Priority date	Feb 4, 2013
Publication date	Jun 9, 2016
Grant date	—

Abstract

Methods and compositions for populating the gastrointestinal tract of a subject are described. Methods include administering to a subject a therapeutic composition comprising a purified population of spore-forming bacteria produced by providing a fecal material and subjecting the material to a treatment step resulting in purification of spore forming bacteria. Methods include administering an amount effective to engraft and/or augment in the gastrointestinal tract in order to treat or prevent a dysbiosis in the mammalian subject.

First claim

1 . A method of populating the gastrointestinal tract of a mammalian subject, comprising the step of orally administering to the mammalian subject an effective amount of a therapeutic composition comprising a purified population of spore-forming bacteria produced by the steps of a) providing a fecal material and b) subjecting the material to a treatment step resulting in purification of spore-forming bacteria, wherein the purified population is present in an amount effective to engraft and/or augment in the gastrointestinal tract in order to treat or prevent a dysbiosis in the mammalian subject.

2 . A method of populating the gastrointestinal tract of a mammalian subject, comprising the step of orally administering to the subject an effective amount of a therapeutic composition comprising a purified population of spore-forming bacteria, in an amount effective to engraft and/or augment in the gastrointestinal tract in order to treat or prevent a dysbiosis in a mammalian subject.

3 .- 14 . (canceled)

15 . The method of claim 1 , wherein the dysbiosis comprises i) a gastrointestinal disease, disorder or condition selected from the group consisting of Clostridium difficile -induced diarrhea, irritable bowel syndrome (IBS), colonization with a pathogen or pathobiont, infection with a drug-resistant pathogen or pathobiont, colitis, and Crohn's Disease, or ii) a non-gastrointestinal disease, disorder or condition.

16 .- 22 . (canceled)

23 . A therapeutic composition comprising a purified population of spore-forming bacteria or bacteria having a substantial activity of spore-forming bacteria, in an amount effective to populate the gastrointestinal tract of a mammalian subject to whom the therapeutic composition is administered.

24 .- 52 . (canceled)

53 . The therapeutic composition of claim 23 , wherein the purified population is obtained by the steps of a) providing a fecal material comprising spore-forming bacteria and b) subjecting the spore-forming bacteria to a treatment step resulting in purification of the spore-forming bacteria.

54 .- 70 . (canceled)

71 . A method for production of the therapeutic composition of claim 23 , comprising the steps of: (a) providing a fecal material obtained from a mammalian donor subject; and (b) subjecting the fecal material to at least one purification step under conditions such that a purified population of spore-forming bacteria is produced from the fecal material.

72 .- 74 . (canceled)

75 . A method of treating or preventing a dysbiosis in a human subject, comprising administering to the human subject the therapeutic composition of claim 23 .

76 . The method of claim 75 , wherein the therapeutic administration comprises oral administration of a composition comprising at least about 1×10 4 colony forming units of bacterial spores per dose of the composition.

77 . The method of claim 76 , wherein the bacterial spores comprise bacteria from the genera provided in Table 1.

78 .- 120 . (canceled)

Assignees

• Seres Therapeutics Inc

Inventors

• Von Maltzahn Geoffrey
• Henn Matthew R
• Cook David N
• Berry David Arthur
• Afeyan Noubar B
• Goodman Brian
• Mckenzie Mary-Jane Lombardo
• Vulic Marin

Classifications

• A61P31/04

  Antibacterial agents · CPC title

• A61P1/00

  Drugs for disorders of the alimentary tract or the digestive system · CPC title

• A61P1/12

  Antidiarrhoeals · CPC title

• A61P1/04

  for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants · CPC title

• A61K9/48

  Preparations in capsules, e.g. of gelatin, of chocolate {(A61K9/0004 takes precedence; bite capsules A61K9/0056)} · CPC title