NCT06311006 Safety Registry of a Fecal Microbiota Transplant Cohort
| NCT ID | NCT06311006 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Clostridium Difficile Infections |
| Study Type | OBSERVATIONAL |
| Enrollment | 305 participants |
| Start Date | 2021-01-04 |
| Primary Completion | 2029-01-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 305 participants in total. It began in 2021-01-04 with a primary completion date of 2029-01-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Clostridium difficile infection (CDI) is a major cause of infectious diarrhea and the most important cause of nosocomial diarrhea. Recurrent forms are a major problem with this infection. The use of fecal microbiota transplantation (FMT), FMT appears in the most recent European and North American recommendations. There is no cohort or multicenter registry in France prospectively collecting FMTs, the methods used, their efficacy and side effects. Likewise, there is no prospective collection focused on the cohort of stool donors. A large national cohort of patients who have undergone FMT as part of routine care as well as donors, is essential for evaluating the safety of FMT.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06311006 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Clostridium Difficile Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06311006 currently recruiting?
Yes, NCT06311006 is actively recruiting participants. Contact the research team at harry.sokol@aphp.fr for enrollment information.
Where is the NCT06311006 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06311006 clinical trial?
NCT06311006 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 305 participants.