Harnessing the Healthy Gut Microbiota to Cure Patients With Recurrent C. Difficile Infection
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Clostridium Difficile Infection |
Biological: "synthetic stool" or pure cultures of probiotic intestinal bacteria |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- number of participants cured of CDI [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: synthetic stool
"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
|
Biological: "synthetic stool" or pure cultures of probiotic intestinal bacteria
"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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- patients with recurrent CDI that have failed standard therapy
Exclusion Criteria:
- critically ill patients
Contacts and Locations| Contact: Elaine Petrof, MD | (613) 549-6666 ext 6516 | eop@queensu.ca |
| Canada, Ontario | |
| Kingston General Hospital | Recruiting |
| Kingston, Ontario, Canada, K7L 2V7 | |
| Contact: Elaine Petrof, MD (613) 549-6666 ext 6516 eop@queensu.ca | |
| Principal Investigator: Elaine Petrof, MD | |
| Sub-Investigator: Stephen Vanner, MD | |
| Sub-Investigator: Emma Allen-Vercoe, Ph.D | |
| Principal Investigator: | Elaine Petrof, MD | Kingston General Hospital |
More Information
No publications provided
| Responsible Party: | Queen's University |
| ClinicalTrials.gov Identifier: | NCT01372943 History of Changes |
| Other Study ID Numbers: | DMED 1318-10 |
| Study First Received: | June 8, 2011 |
| Last Updated: | April 27, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Queen's University:
|
Clostridium difficile recurrent infection |
Additional relevant MeSH terms:
|
Clostridium Infections Gram-Positive Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on May 16, 2013