drugset / Trial / NCT02112279

Reduction of C-Difficile Infection Using Stool Transplant

NCT02112279 ↗

Phase 1 Unknown 10 enrolled Providence Holy Cross Medical Center
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2014-04
Primary completion
2015-06
Completion
2015-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Donor microbiota Other / unclassified 300 ml Other
Subject Donor microbiota Other / unclassified 700 ml Other