Fecal microbiota transplantation for treating recurrent C. difficile infections
Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | University of Massachusetts, Worcester Academic / other |
| Locations | 1 site (Worcester, Massachusetts) |
| Trial ID | NCT03562741 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with two or more recurrences of C. difficile infection who have not responded to standard antibiotic therapies.
Not a fit: Patients under 16 years old or those with acute severe colonic dilation are unlikely to benefit from this study.
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 performed: Previous studies have shown high success rates for fecal microbiota transplantation in treating recurrent C. difficile infections, indicating a promising approach.
Eligibility criteria
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 this trial is running
Worcester, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.