Clinical trial Recruiting at 1 site Observational Ages 18 and up

Registry for fecal microbiota transplants in Clostridium difficile infections

Official title: Safety Registry of a Fecal Microbiota Transplant Cohort (COSMIC-FMT)

Run by Assistance Publique - Hôpitaux de Paris · NCT06311006 · Data updated 2026-11-12

This study is creating a national registry to see how well fecal microbiota transplants work for people with Clostridium difficile infections and to gather information about the process and any side effects.

More Clostridium Difficile Infection trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment305 (estimated)
SponsorAssistance Publique - Hôpitaux de Paris
Academic / other
Locations1 site (Paris)
StatusRecruiting
StartedJanuary 4, 2021
Main results expectedJanuary 4, 2029
Study endsJanuary 4, 2029
Registry record updatedAugust 18, 2026
Trial IDNCT06311006 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults with severe refractory or recurrent CDI who are indicated for FMT.

Probably not a fit

Patients who do not understand written and spoken French may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to create a national cohort registry in France for patients undergoing fecal microbiota transplantation (FMT) for Clostridium difficile infections (CDI). It will collect data on the methods used, efficacy, and side effects of FMT, as well as information on stool donors. The study addresses the increasing incidence and severity of CDI, particularly in recurrent cases, which pose significant therapeutic challenges. By evaluating the safety and effectiveness of FMT, the study seeks to provide valuable insights into this treatment option.

Why it matters

Potential benefit: If successful, this study could improve treatment outcomes for patients suffering from recurrent Clostridium difficile infections.

How similar studies have gone: Previous studies have shown that fecal microbiota transplantation is superior to antibiotic therapy in reducing recurrences of CDI, indicating a promising approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

Patients :

* Adult patient with an indication for FMT for CDI (severe refractory CDI, recurrent CDI);
* Informed written consent

Donors:

* Adult (18 years or older)
* Informed Written consent

Exclusion Criteria:

* insufficient level of understanding of written and spoken French language

Where it's running

  • Gastroenterology Department of Saint Antoine Hospital
    Paris, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.