The clinical trial aims to evaluate the efficacy of fecal microbiota transplantation (FMT) after standard of care treatment (either vancomycin or fidaxomicin) vs the pragmatic use of standard of care treatment (either vancomycin or fidaxomicin) in severe and non-severe first episode and first recurrence of Clostridioides difficile infection (CDI).
Experimental arm: antibiotic treatment (vancomycin or fidaxomicin as initially prescribed per SoC continued for 10 days) followed by FMT by oral capsules (one FMT, i.e. 20 FMT capsules given on 2 consecutive days, and followed by a 2nd FMT in severe CDI).
Control Arm: vancomycin or fidaxomicin as initially prescribed per SoC continued for 10 days.
Adults (≥18 years old) at the time of informed consent
Informed consent signature
age >65 years-old,
hospitalization within the last 3 months,
ongoing at time of screening and related to CDI: hypotension, septic shock, elevated serum lactate, ileus,
or were present at any time of the CDI episode and related to CDI: toxic megacolon, bowel perforation, or any fulminant course of disease (i.e. rapid deterioration of the patient.
Prior FMT within 6 months of randomization,
Prior total colectomy, colostomy, ileostomy, or gastrectomy
Benoit Guery
Lead sponsor
Centre Hospitalier Universitaire Vaudois
Sponsor institution