NCT03562741 Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile
| NCT ID | NCT03562741 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Krunal Patel |
| Condition | Clostridium Difficile Infection Recurrence |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2014-01-16 |
| Primary Completion | 2028-01-16 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2014-01-16 with a primary completion date of 2028-01-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Anne Foley
✉ Anne.Foley@umassmed.eduKrunal Patel
PRINCIPAL INVESTIGATOR
UMass Medical School
Frequently Asked Questions
Who can join the NCT03562741 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Clostridium Difficile Infection Recurrence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03562741 currently recruiting?
Yes, NCT03562741 is actively recruiting participants. Contact the research team at Anne.Foley@umassmed.edu for enrollment information.
Where is the NCT03562741 trial being conducted?
This trial is being conducted at Worcester, United States.
Who is sponsoring the NCT03562741 clinical trial?
NCT03562741 is sponsored by Krunal Patel. The principal investigator is Krunal Patel at UMass Medical School. The trial plans to enroll 500 participants.