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Method for treatment of disorders of the gastrointestinal system

a gastrointestinal system and disorder technology, applied in the field of synthetic stool preparation, can solve the problems of reducing inflammation, and affecting the treatment effect of patients with multiple recurrences, so as to prevent recurrence and reduce inflammation

Inactive Publication Date: 2014-12-11
UNIVERSITY OF GUELPH +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0019]In other aspects, there is provided a method for treating Clostridium difficile infection comprising administering the synthetic stool preparation of the invention to a subject in need thereof. There is also provided a method for treating recurrent Clostridium difficile infection comprising administering the synthetic stool preparation of the invention to a subject in need thereof and a method for preventing recurrence of Clostridium difficile infection comprising administering the synthetic stool preparation of the invention to a subject in need thereof. Methods for treating Crohn's disease, ulcerative colitis, irritable bowel syndrome, inflammatory bowel disease and / or diverticular disease using the synthetic stool preparations of the invention are also provided.
[0021]In another embodiment, sporulation of Clostridium difficile is prevented or inhibited after administration of a synthetic stool preparation of the invention. In yet another embodiment, C. difficile toxin, e.g., toxin A or toxin B, is neutralized after administration of a synthetic stool preparation of the invention, or a subject is protected against C. difficile toxin after administration of a synthetic stool preparation of the invention.

Problems solved by technology

CDI is one of the primary hospital-acquired infections and is a significant infectious disease problem in the U.S., Canada and worldwide.
Unfortunately, few effective treatments exist for those patients with multiple recurrences of CDI.
However, antibiotics are not always effective, and recurrences and relapses are common after antibiotic treatment.
However, stool transplants require costly and time-consuming screening of donors for major pathogens before therapy can proceed, are not reproducible and controllable, can contain pathogenic bacteria and viruses, and often carry a psychological and sociological stigma for the patient.

Method used

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  • Method for treatment of disorders of the gastrointestinal system
  • Method for treatment of disorders of the gastrointestinal system
  • Method for treatment of disorders of the gastrointestinal system

Examples

Experimental program
Comparison scheme
Effect test

example 1

Isolation of Bacterial Strains

[0112]A healthy donor was identified and screened for suitability as a fecal transplant donor using a standard panel of microbiology tests. The most important criterion for donor selection was the donors prior exposure to antibiotic therapy. Our donor had only one reported antibiotic exposure, 5 years prior to donation, and cannot recall having had any during her childhood, which is believed to be the critical time during which the gut microbiota develop.

[0113]All the bacterial strains used in the synthetic stool preparations of the invention were isolated from a single donor. Without wishing to be bound by theory, it is believed that strains that have evolved together in one host may work synergistically together and that it may therefore be preferable to use strains isolated from a single donor.

[0114]The donor was asked to void feces in a private bathroom near the lab, into a provided sterile pot. The pot was immediately transported to the lab and pla...

example 2

Antibiotic Resistance Profiling of Isolated Bacterial Strains

[0145]For antibiotic resistance profiling, the standard Bauer-Kirby method of antibiotic disc diffusion was used. Each isolate was separately cultured according to optimal conditions (see Table 3), and then a suspension was made to McFarland standard of 0.5 in sterile, pre-reduced saline. 100 uL of this was spread onto agar plates containing agar formulations optimal for the tested strain (as shown in Table 3). To the surface of the inoculated plates, an antibiotic disc was applied (antibiotic discs were purchased from Sigma). Plates were inoculated for 1-4 days, depending on the isolate, until good growth was seen. The zone of clearance (area with no bacterial growth) around each disc for each strain was then measured in mm using a ruler. The larger the zone of clearance, the more sensitive the tested isolate to the tested antibiotic. Zones of clearance are given as measurements of the diameter of the zone of clearance (i...

example 3

Treatment of CDI Using a Synthetic Stool Preparation

[0149]Here we describe the use of a synthetic stool preparation to treat recurrent CDI which failed repeated standard antibiotic treatments. We report the successful outcome of 2 patients with recurrent CDI unresponsive to conventional therapy who received a “synthetic” stool preparation of 33 different intestinal bacteria isolated in pure culture, from a single healthy donor. Patients reported complete cure of recurrent CDI after receiving the synthetic stool preparation, and remained symptom free after 6 months of follow-up. Bioinformatic analysis demonstrated that microbial profile reverts to features of the synthetic stool in each case.

[0150]Embodiments of the synthetic stool preparation shown in Tables 2 and 2a were used in these studies. The terms “RePOOPulate” (also abbreviated “RP” for “RePOOPulate Preparation”) and “MET” are used interchangeably herein to refer to embodiments of the synthetic stool preparation shown in Tab...

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Abstract

There are provided novel synthetic stool preparations comprising bacteria isolated from a fecal sample from a healthy donor. The synthetic stool preparations are used for treating disorders of the gastrointestinal tract, including dysbiosis, Clostridium difficile infection and recurrent Clostridium difficile infection, prevention of recurrence of Clostridium difficile infection, treatment of Crohn's disease, ulcerative colitis, irritable bowel syndrome, inflammatory bowel disease, and diverticular disease, and treatment of food poisoning such as salmonella. Methods of preparation and methods of use of the synthetic stool preparations are also provided.

Description

RELATED APPLICATIONS[0001]This application claims priority to U.S. provisional application No. 61 / 534,456, filed on Sep. 14, 2011, the entire contents of which are hereby incorporated by reference. This application is related to copending international PCT application titled “Methods to Culture Human Gastrointestinal Microorganisms,” filed Sep. 14, 2012, the entire contents of which are hereby incorporated by reference.FIELD OF THE INVENTION[0002]This invention relates to a synthetic stool preparation and methods of use thereof for treating disorders associated with dysbiosis of the gastrointestinal tract, such as Clostridium difficile infection, including recurrent Clostridium difficile infection.BACKGROUND OF THE INVENTION[0003]Clostridium difficile infection (CDI) is a bacterial infectious disease of the gastrointestinal tract caused by Clostridium difficile (C. difficile), a toxin-producing Gram-positive anaerobic, spore-forming bacillus. CDI accounts for 15-25% of antibiotic-as...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K35/74
CPCA61K35/74A61K35/745A61K35/747C12N1/20A61P1/12A61P29/00A61P31/04C12R2001/145C12N1/205C12R2001/01
Inventor ALLEN-VERCOE, EMMAPETROF, ELAINE OLGA
Owner UNIVERSITY OF GUELPH
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