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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ 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

Locations
Other Locations
France
Gastroenterology Department of Saint Antoine Hospital
RECRUITING
Paris
Contact Information
Primary
Harry SOKOL, MD, PhD
harry.sokol@aphp.fr
0033 1 49 28 31 62
Time Frame
Start Date: 2021-01-04
Estimated Completion Date: 2029-01-04
Participants
Target number of participants: 305
Treatments
Patients
adult patients for whom FMT for CDI is indicated and planned as part of the routine care (definition of CDI and recurrence according to European recommendations 2014 10)
Stool donor
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov