Harnessing the Healthy Gut Microbiota to Cure Patients With Recurrent C. Difficile Infection
Information source: Queen's University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Clostridium Difficile Infection
Intervention: "synthetic stool" or pure cultures of probiotic intestinal bacteria (Biological)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Queen's University Official(s) and/or principal investigator(s): Elaine Petrof, MD, Principal Investigator, Affiliation: Kingston General Hospital
Summary
CDI (Clostridium difficile infection) causes diarrheal illness and can cause colitis which
may be fatal. A patient being treated for CDI has a 10-25% chance of developing relapse.
Recurrent CDI is on the rise. There are few options available to treat recurrent CDI. "Stool
transplant" (infusing donor stool into the intestine of the recipient), is not very
palatable to either patient or medical personnel. The investigators will isolate intestinal
bacteria from donor stool and use this purified mixture of donor bacteria instead of stool
transplant. The investigators hypothesize that this cleaner mixture of purely isolated
intestinal bacteria from a healthy donor would be equally effective as conventional fecal
bacteriotherapy, which uses donor stool. The use of this prepared mixture of aerobic and
anaerobic organisms, or probiotic approach, is based on the same principle of fecal flora
reconstitution. However our approach would provide a more controlled, reproducible, cleaner
and more aesthetically acceptable method of administration, and from a patient safety
perspective, would also be a safer strategy than using freshly defecated donor fecal matter.
Clinical Details
Official title: A Study Using "Synthetic Stool" or Pure Cultures of Probiotic Intestinal Bacteria From Healthy Donor Stool That Can be Used as an Enema to Replace the Use of Stool Transplant, for Treatment of Recurrent and Refractory CDI
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: number of participants cured of CDI
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- patients with recurrent CDI that have failed standard therapy
Exclusion Criteria:
- critically ill patients
Locations and Contacts
Kingston General Hospital, Kingston, Ontario K7L 2V7, Canada
Additional Information
Starting date: January 2010
Last updated: November 6, 2013
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