TerminatedPhase 3

Fecal Transplantation for Primary Clostridium Difficile Infection

Stopped: Pre-specified non-inferiority criterion met at interim analysis.

Norway104 participantsStarted 2019-07-17

Plain-language summary

In this randomized controlled trial the investigators want to compare the effect of one-time rectal instillation of fecal microbiota transplantation, compared to a ten-day antibiotic course for the treatment of primary Clostridium difficile infection (CDI). The investigators hypothetsize that the instillation of feces from a healthy donor will be non-inferior to vancomycin in inducing a durable cure.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Diarrhea as defined by the WHO (≥3 loose stools per day), and
✓. Positive stool test for toxin producing C. difficile, and
✓. No evidence of previous C. difficile infection during 365 days before enrolment.

What they're measuring

Patients with durable cure

Timeframe: 60 days

Trial details

NCT IDNCT03796650

SponsorOslo University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-02

View on ClinicalTrials.gov More Clostridium Difficile Infection trials