Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorKrunal Patel
About this trial
The purpose of this study is to see if stool transplant performed by colonoscopy is effective at treating recurrent Clostridium difficile (C. diff) infection of the colon. During the procedure a stool sample is taken from a healthy donor (usually family member or close friend) and transplanted directly into the colon of the patient with C. diff infection. The goal of this experimental procedure (called fecal microbiota transplantation) is to replenish the good bacteria in the colon that can help prevent C. diff infection from coming back after treatment.
Eligibility criteria
Qualifiers
Two or more recurrences of C. difficile infection (CDI) with recurrence defined as a positive test result, e.g. Polymerase Chain Reaction (PCR) test and with appropriate symptoms within 2-8 weeks of last positive result, provided that symptoms from earlier episode resolved with or without therapy.
Failed standard therapy with oral metronidazole and/or oral vancomycin
One or more episodes of severe CDI resulting in hospitalization and not responding to standard antibiotic therapy. Hospitalization for CDI occurs in the setting of severe diarrhea, abdominal pain and signs of systemic toxicity
Disqualifiers
Age <16 years old
patients with acute severe colonic dilation at risk for colonic perforation
Trial design
Treatments tested in this trial
- Fecal Microbiota Transplantation
Treatment groups
500 Participants
are divided into 1 treatment groupSponsors and collaborators
Krunal Patel
Lead sponsor
University of Massachusetts, Worcester
Sponsor institution
Source ClinicalTrials.gov