Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile
Recruiting now · Not applicable
Conditions studied: Clostridium Difficile Infection Recurrence, Clostridium Difficile Infection
In brief
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.
Key facts
- Study ID
- NCT03562741
- Run by
- Krunal Patel
- People needed
- 500
- Starts
- 2014-01-16
- Expected to finish
- 2029-01-16
- Last updated by the study team
- 2026-02-20
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Age <16 years old
- patients with acute severe colonic dilation at risk for colonic perforation
Where it is running
- UMass Memorial Medical Center — Worcester, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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