Reduction of C-Difficile Infection Using Stool Transplant
Status unconfirmed · Phase 1
Conditions studied: C-difficile
In brief
Clostridium-difficile (C-difficile) is a gram positive anaerobic spore-forming bacterium that can lead to severe diarrhea and pseudomembranous colitis. According to Schroeder (2005), there are approximately 3 million cases annually with a mortality rate of 1-2.5 %. It is most often associated with overuse of antibiotics. According to Bartlett \& Gerding (2008), 15-25% of anti-microbial-associated diarrhea is caused by C-difficile. The purpose of this study is to determine if donor fecal microbiota transplant via colonoscopy reduces refractory C-difficile infection better than current routine methods such as continued antibiotic treatment. Specifically, we hypothesize that fecal microbiota transplant via colonoscopy will result in a higher C-difficile cure rate in affected patients versus care as usual in a retrospective cohort.
Key facts
- Study ID
- NCT02112279
- Run by
- Providence Holy Cross Medical Center
- People needed
- 10
- Starts
- 2014-04-01
- Expected to finish
- 2015-06-01
- Last updated by the study team
- 2015-01-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must be 18 years of age or older
- Patient must have a positive C. difficile test within the 10 days prior to the procedure
- Continued symptoms of c-difficile infection
- Patients must have failed at least two courses of appropriate antibiotic therapy for C. diff to be a candidate for this procedure
You may not qualify if…
- Under 18 years of age
- Negative C. difficile test within the 10 days prior to the procedure
- No symptoms of c-difficile infection
- Less than two courses of appropriate antibiotic therapy for C. difficile infection
Where it is running
- Providence Holy Cross Medical Center — Mission Hills, California, United States (enrolling)
Full record on ClinicalTrials.gov
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