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Fecal Microbiota Transplantation in Clostridioides Difficile Infection First Episode and First Recurrence
Sponsor: Benoit Guery
Summary
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.
Official title: Fecal Microbiota Transplantation Versus Vancomycin or Fidaxomicin in Clostridioides Difficile Infection First Episode or First Recurrence: A Randomized Controlled, Open-label, Multicenter Phase III Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
220
Start Date
2023-03-15
Completion Date
2028-01-31
Last Updated
2025-09-18
Healthy Volunteers
No
Conditions
Interventions
oral capsulized Fecal Microbiota Transplantation
FMT will be administered per os in the form of capsules containing faeces from a healthy donor. Capsules are manufactured at the CHUV pharmacy (University Hospital of Lausanne, Switzerland)
Vancomycin or Fidaxomicin
Vancomycin or Fidaxomicin per os as initially prescribed per SoC
Locations (7)
Universitätsspital
Basel, Basel, Switzerland
Inselspital Bern
Bern, Canton of Bern, Switzerland
HFR Fribourg - Hôpital cantonal
Fribourg, Canton of Fribourg, Switzerland
Kantonsspital St Gallen, HOCH
Sankt Gallen, Canton of St. Gallen, Switzerland
CHUV
Lausanne, Canton of Vaud, Switzerland
Universitätsspital Zürich
Zurich, Canton of Zurich, Switzerland
Institut central des hôpitaux
Sion, Valais, Switzerland