protocolSection identificationModule nctId: NCT06311006, orgStudyIdInfo id: K170103J, secondaryIdInfos id: 2019-A02579-48, type: OTHER, domain: ANSM, briefTitle: Safety Registry of a Fecal Microbiota Transplant Cohort, acronym: COSMIC-FMT, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-01-04, primaryCompletionDateStruct date: 2029-01-04, completionDateStruct date: 2029-01-04, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Clostridium Difficile Infections, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 305, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Proportion of hospitalizations attributable to FMT, secondaryOutcomes measure: Proportion of Clostridium difficile relapses, secondaryOutcomes measure: Proportion of relapse, secondaryOutcomes measure: Proportion of reinfections, secondaryOutcomes measure: Efficacy of FMT in CDI (defined as free from relapse) at 10 weeks and 3 years according to clinical characteristics of donors, secondaryOutcomes measure: Efficacy of FMT in CDI (defined as free from relapse) at 10 weeks and 3 years according to clinical characteristics of patients, secondaryOutcomes measure: Efficacy of FMT in CDI (defined as free from relapse) at 10 weeks and 3 years according to the method of preparation and administration of fecal preparation, secondaryOutcomes measure: Evolution of transit (i.e. number of stools per day and their consistency) and mean BMI in patients Correlation between the evolution of transit and the BMI of the donor and the patient., secondaryOutcomes measure: Patient status (absence of recurrence or relapse or re-infection) according to the composition of the microbiota (by sequencing or metabolomic method or culture) of the donors., secondaryOutcomes measure: Composition of the patient's microbiota before FMT and at week 10 and composition of the donor's microbiota (by sequencing or metabolomic method or culture) of the raw stool and the preparation to be administered to the patient., secondaryOutcomes measure: adverse event rate, secondaryOutcomes measure: Metabolomic, immunological analysis (phenotype of peripheral blood immune cells) of the donor and the patient before and after FMT (at W10)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gastroenterology Department of Saint Antoine Hospital, status: RECRUITING, city: Paris, zip: 75012, country: France, contacts name: Harry SOKOL, MD, PhD, role: CONTACT, phone: 0033 1 49 28 31 62, phoneExt: +33, email: harry.sokol@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False