Fecal Microbiota Transplantation in Clostridioides Difficile Infection First Episode and First Recurrence
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
Benoit Guery
100 participants
Mar 15, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
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 per os as initially prescribed per SoC
Locations(8)
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NCT05266807