RecruitingNCT06311006

Safety Registry of a Fecal Microbiota Transplant Cohort

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


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

305 participants

Start Date

Jan 4, 2021

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria1

  • insufficient level of understanding of written and spoken French language

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Locations(1)

Gastroenterology Department of Saint Antoine Hospital

Paris, France

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NCT06311006


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