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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

Page last updated: August 23, 2015

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