Fecal microbiota transplantation for treating recurrent C. difficile infections
Official title: Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile
Run by University of Massachusetts, Worcester · NCT03562741 · Data updated 2026-11-12
This study is testing whether a stool transplant from a healthy donor can help people with repeated C. difficile infections feel better compared to regular antibiotic treatments.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 16 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | University of Massachusetts, Worcester Academic / other |
| Locations | 1 site (Worcester, Massachusetts) |
| Status | Recruiting |
| Started | January 16, 2014 |
| Main results expected | January 16, 2028 |
| Study ends | January 16, 2029 |
| Registry record updated | February 20, 2026 |
| Trial ID | NCT03562741 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with two or more recurrences of C. difficile infection who have not responded to standard antibiotic therapies.
✕Probably not a fit
Patients under 16 years old or those with acute severe colonic dilation are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of fecal microbiota transplantation (FMT) performed via colonoscopy for patients suffering from recurrent Clostridium difficile infections. The procedure involves transplanting stool from a healthy donor into the colon of the patient to restore beneficial gut bacteria. The study aims to standardize the FMT protocol and assess its success rates, costs, and impact on hospitalizations compared to traditional antibiotic treatments. Historical controls will be used to measure outcomes against past patient data.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the recurrence of C. difficile infections and associated healthcare costs for patients.
How similar studies have gone: Previous studies have shown high success rates for fecal microbiota transplantation in treating recurrent C. difficile infections, indicating a promising approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion criteria: * Age \<16 years old * patients with acute severe colonic dilation at risk for colonic perforation
Where it's running
-
UMass Memorial Medical Center
Worcester, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Krunal Patel — UMass Medical School
- Study coordinator: Anne Foley
- Email: Anne.Foley@umassmed.edu
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.