MICROBIOTA RESTORATION THERAPY (MRT), COMPOSITIONS AND METHODS OF MANUFACTURE

• US 20150216917A1
• Filed: 04/17/2015
• Published: 08/06/2015
• Est. Priority Date: 06/05/2013
• Status: Active Grant

• Current Assignee: Rebiotix Inc. (Ferring Holding SA)
• Original Assignee: Rebiotix Inc. (Ferring Holding SA)
• Inventors: JONES, LEE A., JONES, COURTNEY R., HLAVKA, EDWIN J., GORDON, RYAN D.
• Granted Patent: US 10,603,341 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A01N 1/021 Preservation or perfusion media, liquids, solids or gases used in the preservation of cells, tissue, organs or bodily fluids
• CPC Class Codes: A01N 1/0284 Temperature processes, i.e. using a designated change in temperature over time
• CPC Class Codes: A61K 35/38 Stomach; Intestine; Goblet cells; Oral mucosa; Saliva
• CPC Class Codes: A61K 35/74 Bacteria therapeutic use of a bacterial protein A61K38/00
• CPC Class Codes: A61K 35/741 Probiotics probiotic yeast, e.g. saccharomyces A61K36/06
• CPC Class Codes: A61K 35/742 Spore-forming bacteria, e.g. Bacillus coagulans, Bacillus subtilis, clostridium or Lactobacillus sporogenes
• CPC Class Codes: A61K 35/744 Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
• CPC Class Codes: A61K 35/747 Lactobacilli, e.g. L. acidophilus or L. brevis
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 9/0031 Rectum, anus
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: B65B 25/00 Packaging other articles presenting special problems bundling B65B27/00
• CPC Class Codes: B65B 7/02 Closing containers or receptacles deformed by, or taking-up shape, of, contents, e.g. bags, sacks
• CPC Class Codes: C12N 1/20 Bacteria; Culture media therefor
• CPC Class Codes: C12Q 1/04 Determining presence or kind of microorganism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor C12Q1/6897 takes precedence
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

Microbiota restoration therapy compositions and methods for manufacturing, processing, and/or delivering microbiota restoration therapy compositions are disclosed. An example method for manufacturing a microbiota restoration therapy composition may include collecting a human fecal sample and adding a diluent to the human fecal sample to form a diluted sample. The diluent may include a cryoprotectant. The method may also include mixing the diluted sample with a mixing apparatus and filtering the diluted sample. Filtering may form a filtrate. The method may also include transferring the filtrate to a sample bag and sealing the sample bag.

Claims

1. A microbiota restoration therapy composition, comprising:

a processed human fecal preparation;

wherein the processed human fecal preparation includes a fecal sample and a cryoprotectant; and

wherein the processed human fecal preparation is pre-screened for bacterial diversity and includes bacteria from six or more different taxonomic families.

2. The microbiota restoration therapy composition of claim 1, wherein the processed human fecal preparation includes bacteria from seven or more different taxonomic families.

3. The microbiota restoration therapy composition of claim 1, wherein the processed human fecal preparation includes bacteria from eight or more different taxonomic families.

4. The microbiota restoration therapy composition of claim 1, wherein the processed human fecal preparation has a Shannon Diversity Index of 0.4-2.5 when calculated at the family level.

5. The microbiota restoration therapy composition of claim 1, wherein the cryoprotectant is polyethylene glycol.

6. The microbiota restoration therapy composition of claim 1, wherein the processed human fecal preparation is collected from a donor having a donor diet, and wherein the processed human fecal preparation is characterized as being effective as a treatment for a disease state based on the donor diet.

7. The microbiota restoration therapy composition of claim 1, wherein the processed human fecal preparation includes bacteria from six or more different taxonomic phyla.

8. The microbiota restoration therapy composition of claim 1, wherein the processed human fecal preparation includes bacteria from six or more different taxonomic classes.

9. The microbiota restoration therapy composition of claim 1, wherein the processed human fecal preparation includes bacteria from six or more different taxonomic orders.

10. The microbiota restoration therapy composition of claim 1, wherein the largest population of the bacteria included in the processed human fecal preparation is from the family Bacteroidaceae.

11. The microbiota restoration therapy composition of claim 10, wherein the second largest population of the bacteria included in the processed human fecal preparation is from the family Ruminococcaceae.

12. The microbiota restoration therapy composition of claim 10, wherein the second largest population of the bacteria included in the processed human fecal preparation is from the family Ruminococcaceae or Rikenellaceae.

13. The microbiota restoration therapy composition of claim 12, wherein the third largest population of the bacteria included in the processed human fecal preparation is from the family Ruminococcaceae, Rikenellaceae, Eubacteriaceae, Clostridiaceae, or Lachnospiraceae.

14. The microbiota restoration therapy composition of claim 1, wherein the largest population of the bacteria included in the processed human fecal preparation is from the order Bacteroidales.

15. The microbiota restoration therapy composition of claim 14, wherein the second largest population of the bacteria included in the processed human fecal preparation is from the order Clostridiales.

16. A microbiota restoration therapy composition, comprising:

a processed human fecal preparation comprising a fecal sample and polyethylene glycol;

wherein the processed human fecal preparation is pre-screened for bacterial diversity and includes bacteria from six or more different taxonomic families;

wherein the largest population of the bacteria included in the processed human fecal preparation is from the family Bacteroidaceae; and

wherein the processed human fecal preparation has a Shannon Diversity Index of 0.4-2.5 when calculated at the family level.

17. The microbiota restoration therapy composition of claim 16, wherein the processed human fecal preparation is collected from a donor having a donor diet, and wherein the processed human fecal preparation is characterized as being effective as a treatment for a disease state based on the donor diet.

18. The microbiota restoration therapy composition of claim 16, wherein the second largest population of the bacteria included in the processed human fecal preparation is from the family Ruminococcaceae or Rikenellaceae.

19. The microbiota restoration therapy composition of claim 17, wherein the third largest population of the bacteria included in the processed human fecal preparation is from the family Ruminococcaceae, Rikenellaceae, Eubacteriaceae, Clostridiaceae, or Lachnospiraceae.

20. A microbiota restoration therapy composition, comprising:

a processed human fecal preparation comprising a fecal sample and polyethylene glycol;

wherein the processed human fecal preparation is pre-screened for bacterial diversity and includes bacteria from a plurality of different taxonomic families;

wherein the largest population of the bacteria included in the processed human fecal preparation is from the family Bacteroidaceae;

wherein the second largest population of the bacteria included in the processed human fecal preparation is from the family Ruminococcaceae or Rikenellaceae; and

wherein the third largest population of the bacteria included in the processed human fecal preparation is from the family Ruminococcaceae, Rikenellaceae, Eubacteriaceae, Clostridiaceae, or Lachnospiraceae.