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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 305 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | January 4, 2021 |
| Main results expected | January 4, 2029 |
| Study ends | January 4, 2029 |
| Registry record updated | August 18, 2026 |
| Trial ID | NCT06311006 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
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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VE303 for preventing recurrent Clostridioides difficile infections
This study is testing a new treatment called VE303 to see if it can help prevent Clostridioides difficile infections from coming back in people who are at high risk.
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Analyzing the evolution and bacterial clearance of Clostridioides difficile infections
This study looks at how Clostridioides difficile infections change over time and how well different treatments work for French-speaking adults in the hospital.
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Orally ingested yeast designed to express a tetra-specific anti-toxin for Clostridioides difficile safety study
This first-in-human trial tests a yeast-based medicine (FZ002) to see if it is safe and tolerable for adults with no active infection, using a placebo for comparison.
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Oral vancomycin to prevent C. difficile infection in critically ill adults
This trial sees if taking oral vancomycin can prevent C. difficile infection in critically ill adults who are receiving systemic antibiotics.
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Investigating Clostridium Difficile Infection in Infants
This study looks at how common Clostridium difficile infections are in infants and what factors might increase the risk, to help improve diagnosis and treatment for these young patients.
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Investigating factors related to Clostridioides difficile infection recurrence
This study is trying to find out how certain body factors, like gut bacteria and genetics, affect the chances of Clostridioides difficile infection coming back in adults who have already been diagnosed with it.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.