Oral Vancomycin Followed by Fecal Transplant Versus Tapering Oral Vancomycin
Status:
Terminated
Trial end date:
2014-10-01
Target enrollment:
Participant gender:
Summary
Recurrent CDI is a growing problem with few treatment options that provide lasting effect.
Fecal transplantation has been shown in several case series to be successful in controlling
recurrent CDI. The current study is a non-blinded, randomized controlled trial comparing
fecal transplantation with a 6 week taper of oral vancomycin for the treatment of refractory
CDI. Approximately 146 patients will be enrolled over one year. Participants in the study
will be followed for 120 days, and will be given the opportunity to cross over to the
alternative intervention arm if a relapse in symptoms occurs. The primary outcome measure
will be recurrence of toxin-confirmed CDI within 120 days of starting the intervention.
Secondary outcomes include: early recurrence of symptoms within 14 days, relapse within 120
days (same strain of C. difficile), attributable mortality, hospitalization and serious
adverse events.