Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05266807
PHASE3

Fecal Microbiota Transplantation in Clostridioides Difficile Infection First Episode and First Recurrence

Sponsor: Benoit Guery

View on ClinicalTrials.gov

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

Interventions

DRUG

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)

DRUG

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