drugset / Trial / NCT02801656

Fecal Microbiota Transplantation for Primary Clostridium Difficile Diarrhea

NCT02801656

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Clostridium difficile associated diarrhea (CDAD) is a significant cause of morbidity and mortality, caused by loss of healthy gut flora. Conventional treatment uses antibiotics to kill Clostridium difficile. A novel treatment uses replacement of gut flora by fecal microbiota transplant (FMT). Randomized trials have established safety and efficacy of FMT in recurrent CDAD, but no trial has used FMT for primary CDAD. This study will randomize patients to oral encapsulated FMT or oral Vancomycin.

Timeline

Start
2020-12-01
Primary completion
2022-09-01
Completion
2022-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Ornidazole Other / unclassified Oral
Comparator Vancomycin Other / unclassified 125 mg Oral