Safety of FMT: OpenBiome Outcomes and Longitudinal Follow-up (STOOL) for Recurrent Clostridium Difficile Infection
Status:
Terminated
Trial end date:
2018-06-01
Target enrollment:
Participant gender:
Summary
The overarching objective of this study is to address the knowledge gap regarding the
short-term and long-term safety of fecal microbiota transplants (FMT). The design will be a
prospective, open-label, multi-center longitudinal cohort study to assess the short- and
long-term safety of FMT as well as the clinical resolution of diarrhea among 150 patients
with 3 or more episodes of clostridium difficile infection (CDI defined as 3 unformed stools
over 24 hours for 2 consecutive days and either a positive stool test for CDI or
pseudomembranes on colonoscopy/sigmoidoscopy). Subjects will be adult outpatients referred to
one of the study centers after at least three recurrent episodes of CDI and previous
treatment with at least one 10-day course of oral vancomycin or fidaxomicin. After FMT by
colonoscopy/sigmoidoscopy or enema, patients will be followed prospectively and monitored for
clinical resolution and adverse events at: 3 days (telephone), 3 weeks (clinical assessment),
8 weeks (telephone), 6 months (telephone), and 12 months (telephone) after FMT. Subjects who
recur will be offered a second FMT by colonoscopy with a different donor. Microbiome analysis
will be conducted from stool samples at baseline and each of the 5 follow-up intervals.
Phase:
Phase 2
Details
Lead Sponsor:
Microbiome Health Research Institute
Collaborators:
Brown University Edward Hospital Indiana University Montefiore Medical Center Mount Sinai Hospital, New York Tufts Medical Center University of Utah University of Virginia