TerminatedPhase 2

FMT Versus Antimicrobials for Initial Treatment of Recurrent CDI

Stopped: Due to personnel issues for finding and enrolling patients, performing appropriate follow-up and performing FMT procedure

United States6 participantsStarted 2015-01

Plain-language summary

The purpose of the study is to determine the safety and efficacy of Fecal Microbiota Transplant (FMT) for the treatment of the recurrence of Clostridium difficile infection (CDI) as compared to standard antibiotic therapy. Patients who have tested positive for CDI within 90 days of an admission for relapse of CDI will be approached to participate in this open-label, randomized controlled trial. Patients will either be randomized to the intervention group (receive FMT via retention enema) or the control group (receive antimicrobials targeting CDI).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of active C. difficile infection, defined as \> 3 diarrheal stools per day and a positive C. difficile PCR assay * Hospitalized patient presenting with first relapse of CDI occuring between 15 and 90 days after an index episode of CDI Exclusion Criteria: * Pregnancy * Neutropenia (absolute neutrophil count \<1000/microliters) * Contraindication for retention enema * Food allergy not controlled in the donor diet

What they're measuring

Number of Patients With Clinical Resolution of Diarrhea

Timeframe: 90 days

Trial details

NCT IDNCT02255305

SponsorEndeavor Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-01

Results submitted2022-11-11

View on ClinicalTrials.gov More Clostridium Difficile Infection trials