RecruitingPhase 3NCT05266807

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


Sponsor

Benoit Guery

Enrollment

100 participants

Start Date

Mar 15, 2023

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Vancomycin or Fidaxomicin and a drug called oral capsulized Fecal Microbiota Transplantation for people with clostridioides difficile infection. The study is currently recruiting participants at 8 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGoral 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)

DRUGVancomycin or Fidaxomicin

Vancomycin or Fidaxomicin per os as initially prescribed per SoC


Locations(8)

Universitätsspital

Basel, Basel, Switzerland

Inselspital Bern

Bern, Canton of Bern, Switzerland

HFR Fribourg - Hôpital cantonal

Fribourg, Canton of Fribourg, Switzerland

Hirslanden Klinik St Anna

Lucerne, Canton of Lucerne, 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

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NCT05266807


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