Synergistic bacterial compositions and methods of production and use thereof

Patent metadata

Field	Value
Publication number	US-9533014-B2
Application number	US-201514592481-A
Country	US
Kind code	B2
Filing date	Jan 8, 2015
Priority date	Nov 23, 2012
Publication date	Jan 3, 2017
Grant date	Jan 3, 2017

Abstract

Provided are therapeutic compositions containing Ecobiotic™ populations for prevention, treatment and reduction of symptoms associated with a dysbiosis of a mammalian subject such as a human.

First claim

What is claimed is:

1. A method of treating an occurrence or a recurrence of a Clostridium difficile infection, comprising administering to a human subject in need thereof an effective amount of a therapeutic composition comprising a first purified bacterial population consisting of a first bacteria comprising a 16S rDNA sequence at least about 97% identical to a 16S rDNA sequence present in a reference Collinsella aerofaciens OTU, and a second purified bacterial population consisting of a second bacteria comprising a 16S rDNA sequence at least about 97% identical to a 16S rDNA sequence present in a reference bacterium of the family Clostridiaceae listed in Table 1, wherein a synergistic combination of the first bacteria and the second bacteria is cytotoxic or cytostatic to a Clostridium difficile.

2. The method of claim 1 , wherein the number of Clostridium difficile bacteria present in or excreted from the gastrointestinal tract of the human subject is detectably reduced within one month of administration of the bacterial composition.

3. The method of claim 1 , wherein the synergistic combination of the first bacteria and the second bacteria is cytotoxic or cytostatic to Clostridium difficile as demonstrated by a CivSim assay.

4. The method of claim 1 , wherein the therapeutic composition is orally administered.

5. The method of claim 1 , wherein the therapeutic composition comprises a medical food.

6. The method of claim 1 , further comprising administering an effective amount of an anti-bacterial agent, an anti-fungal agent, an anti-viral agent, or an anti-parasitic agent.

7. The method of claim 1 , wherein the synergistic combination is capable of inhibiting proliferation of Clostridium difficile bacterium present at a concentration at least equal to the concentration of the combination of the first bacterial population and the second bacterial population.

8. The method of claim 1 , wherein the first purified bacterial population and the second purified bacterial population are capable of functionally populating the gastrointestinal tract of the human subject to whom the composition is administered.

9. The method of claim 8 , wherein the functional populating of the gastrointestinal tract comprises treating or reducing the severity of or reducing a symptom of a Clostridium difficile infection of the gastrointestinal tract.

10. The method of claim 8 , wherein the functional populating of the gastrointestinal tract comprises i) reducing the number of Clostridium difficile bacteria in the gastrointestinal tract; or ii) increasing the number of one or more non-pathogenic bacteria in the gastrointestinal tract.

11. The method of claim 1 , wherein the second purified bacterial population comprise spores.

Assignees

• Seres Health Inc
• Seres Therapeutics Inc

Inventors

• Henn Matthew R
• Von Maltzahn Geoffrey
• D'Onofrio Anthony Mario
• Litcofsky Kevin Daniel
• Berry David Arthur
• Cook David N
• Afeyan Noubar B
• Aunins John Grant

Classifications

• A61K45/06

  Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca · CPC title

• A23V2002/00

  Food compositions, function of food ingredients or processes for food or foodstuffs · CPC title

• A23P10/30

  Encapsulation of particles, e.g. foodstuff additives · CPC title

• A23L33/135

  Bacteria or derivatives thereof, e.g. probiotics · CPC title

• A61K35/742 Primary

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