Registry for fecal microbiota transplants in Clostridium difficile infections
Safety Registry of a Fecal Microbiota Transplant Cohort (COSMIC-FMT)
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 305 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT06311006 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults with severe refractory or recurrent CDI who are indicated for FMT.
Not a fit: Patients who do not understand written and spoken French may not benefit from this study.
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 performed: Previous studies have shown that fecal microbiota transplantation is superior to antibiotic therapy in reducing recurrences of CDI, indicating a promising approach.
Eligibility criteria
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 this trial is running
Paris
- Gastroenterology Department of Saint Antoine Hospital — Paris, France (Recruiting)
Study contacts
- Study coordinator: Harry SOKOL, MD, PhD
- Email: harry.sokol@aphp.fr
- Phone: 0033 1 49 28 31 62
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.