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

Who can join

Ages 16 and older · All sexes

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

About the study

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.

What is being tested

• Fecal Microbiota Transplantation (procedure)

Sponsor: Krunal Patel · Participants: 500 · Started: Jan 16, 2014

Contact the study team

Official record on ClinicalTrials.gov — NCT03562741

Locations in the U.S.

Conditions

• Clostridium Infections

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.