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Recruiting NCT03562741

Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile

Trial Parameters

Condition Clostridium Difficile Infection Recurrence
Sponsor Krunal Patel
Study Type INTERVENTIONAL
Phase N/A
Enrollment 500
Sex ALL
Min Age 16 Years
Max Age N/A
Start Date 2014-01-16
Completion 2028-01-16
Interventions
Fecal Microbiota Transplantation

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

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