drugset / Trial / NCT03427229

Fecal Microbiota Transplantation for Severe Clostridium Difficile Infection

NCT03427229

Phase 2 Completed 58 enrolled Catholic University of the Sacred Heart
RandomizedParallel-groupOpen-labelTreatment

Summary

Fecal microbiota transplantation (FMT) is acknowledged as a highly effective treatment for recurrent Clostridium difficile infection (CDI). Usually single fecal infusion achieves satisfactory cure rates of recurrent CDI). However, several retrospective studies show that severe clinical picture of recurrent CDI is a risk factor for the failure of single-infusion FMT, suggesting that multiple fecal infusions are required to cure this condition. This is an open-label randomized clinical trial aiming to assess if multiple-infusion FMT is more effective than single-infusion FMT in curing severe CDI

Timeline

Start
2016-03
Primary completion
2017-10-30
Completion
2017-10-30

Drugs

EvaluationDrugModalityDoseRoute
Background Vancomycin Other / unclassified