Fecal Microbiota Transplantation in Clostridioides Difficile Infection First Episode and First Recurrence
Recruiting
Phase 3
Interventional Study
Clostridioides Difficile Infection
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 100 (estimated)
- Sponsor
- Benoit Guery · Other
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About This Trial
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 (vancomyci…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Adults (≥18 years old) at the time of informed consent
2. Informed consent signature
3. Medical record documentation of CDI defined as:
a. A first CDI episode associated with risks factors for recurrence, defined as: i. No CDI episode within the last 8 weeks ii. Current c…
Contacts