Compositions comprising a defined microbiome and methods of use thereof

Patent metadata

Field	Value
Publication number	US-10842832-B2
Application number	US-201816114961-A
Country	US
Kind code	B2
Filing date	Aug 28, 2018
Priority date	Oct 3, 2013
Publication date	Nov 24, 2020
Grant date	Nov 24, 2020

Abstract

The invention features the use of a defined microbial consortia for the replacement of a gut microbiome associated with disease. In particular, the invention provides for the treatment of hyperammonemia, Clostridium difficile colitis, hepatic encephalopathy associated with cirrhosis, and inflammatory bowel disease.

First claim

What is claimed is:

1. A composition comprising a combination of bacteria including Paraprevotella clara, Bifidobacterium longum, Collinsella aerofaciens, Coprococcus comes, Dorea longicatena, Bacteroides eggerthii str ., and Bacteroides vulgates, said bacteria being effective to reduce urease levels in the gut microbiota, said combination being present in a pharmaceutically acceptable carrier suitable for administration to, and colonization of the gut; wherein the composition is lyophilized.

2. The composition of claim 1 , further comprising one or more bacteria selected from the group consisting of urease negative Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus fermentum, Lactobacillus johnsonii Lactobacillus paracasei, Lactobacillus plantarum, Lactobacillus reuteri, Lactobacillus rhamnosus, Lactobacillus salivarius, Lactobacillus lactis, Lactobacillus dubrueckii bulgaricus, Bifidobacterium lactis, Bifidobactenium breve , and Streptococcus thermopiles.

3. A process for preparing a defined microbial consortia composition for decreasing urease levels in the gut, said process comprising;
a) preparing a liquid culture of bacteria cells comprising said defined microbial consortia of claim 1 ;
b) harvesting said cells after a suitable period of growth;
c) resuspending said cells in lyophilization medium, said medium optionally comprising cyroprotectorants, biological or chemical oxygen scavengers;
d) transferring said resuspended cells into a lyophilizer under anaerobic conditions and lyophilizing said cells;
e) packaging said lyophilized cells into a capsule or pill under oxygen free conditions; and
f) optionally packaging said capsules or pill into glass ampoules to maintain anaerobic conditions during shipment and storage.

4. A process for preparing a defined microbial consortia composition for decreasing urease levels in the gut, said process comprising;
a) preparing a liquid culture of bacteria cells comprising said defined microbial consortia of claim 2 ;
b) harvesting said cells after a suitable period of growth;
c) resuspending said cells in lyophilization medium, said medium optionally comprising cyroprotectorants, biological or chemical oxygen scavengers;
d) transferring said resuspended cells into a lyophilizer under anaerobic conditions and lyophilizing said cells;
e) packaging said lyophilized cells into a capsule or pill under oxygen free conditions; and
f) optionally packaging said capsules or pill into glass ampoules to maintain anaerobic conditions during shipment and storage.

5. A capsule comprising the bacteria produced by the process of claim 3 .

6. The composition of claim 2 wherein the composition is present in a capsule.

7. The composition of claim 1 wherein the composition is enclosed in a capsule.

Assignees

• Univ Pennsylvania

Inventors

• Bushman Frederic
• Wu Gary
• Lewis James
• Goulian Mark

Classifications

• A61K35/742

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

• A61K9/19

  lyophilised {, i.e. freeze-dried, solutions or dispersions (lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00)} · CPC title

• A61K31/7036

  having at least one amino group directly attached to the carbocyclic ring, e.g. streptomycin, gentamycin, amikacin, validamycin, fortimicins · CPC title

• A61K31/77

  of oxiranes · CPC title

• A61K35/744

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