Actively Recruiting
Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile
Led by Krunal Patel · Updated on 2026-02-20
500
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating fecal microbiota transplantation (FMT) delivered by colonoscopy as a treatment for patients with recurrent Clostridium difficile infection (C. diff). This study aims to record the success rate of FMT using a standardized protocol, compare its cost to conventional antibiotic treatments, and monitor hospitalizations related to recurrent infections. The trial focuses on patients who have experienced multiple C. diff recurrences and failed standard antibiotic therapies. Participants receive a stool transplant from a healthy donor, usually a family member or close friend, directly into their colon via colonoscopy. This procedure is intended to replenish beneficial bacteria in the colon to help prevent further C. diff infection recurrences. The study follows patients over a 12-month period to assess infection resolution and other outcomes. During the study, participants will undergo assessments to monitor the resolution of C. diff infection, with data collected on infection recurrence and hospitalizations. The primary outcome measure is the resolution of C. diff infection within 12 months. The study also compares costs associated with FMT versus traditional antibiotic treatment. Participants' health and safety will be monitored throughout the study period, which extends up to several years.
CONDITIONS
Brief Title
Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Two or more recurrences of Clostridium difficile infection confirmed by positive test and symptoms within 2 to 8 weeks
- Failed standard therapy with oral metronidazole and/or oral vancomycin
- One or more episodes of severe Clostridium difficile infection resulting in hospitalization not responding to standard antibiotic therapy
You will not qualify if you...
- Age under 16 years old
- Patients with acute severe colonic dilation at risk for colonic perforation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single treatment event
Participants receive fecal microbiota transplantation by colonoscopy to treat recurrent Clostridium difficile infection.
1 procedure visit (in-person)
Duration - Up to 12 months
Participants are monitored for resolution of infection and outcomes for up to 12 months after treatment.
Periodic visits during follow-up
Trial Site Locations
Total: 1 location
1
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
Actively Recruiting
Research Team
A
Anne Foley
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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