drugset / Trial / NCT02801656
Fecal Microbiota Transplantation for Primary Clostridium Difficile Diarrhea
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ornidazole | Other / unclassified | — | Oral |
| Comparator | Vancomycin | Other / unclassified | 125 mg | Oral |