NCT03562741

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

Recruiting
NAAges 16+InterventionalTreatment
Krunal Patel
~500 participants
Updated 2026-02-20 on ClinicalTrials.gov
What's tested:Fecal Microbiota Transplantation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clostridium Difficile (C. diff) resolution'
Measured over 12 months
Clostridium Difficile Infection Recurrence
Clostridium Difficile Infection
1 sites across 1 states
Massachusetts1
  • Krunal Patel · PRINCIPAL_INVESTIGATOR · UMass Medical School

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Eligibility criteria

Inclusion

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

Age \<16 years old
patients with acute severe colonic dilation at risk for colonic perforation
  • Clostridium Difficile (C. diff) resolution'12 months

    Longterm resolution of C. diff associated diarrhea after Fecal Microbiota Transplantation (FMT) therapy