Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-29 @ 2:23 AM
Study NCT ID:
NCT06311006
Status:
RECRUITING
Last Update Posted:
2025-06-25
First Post:
2024-02-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Registry of a Fecal Microbiota Transplant Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003015', 'term': 'Clostridium Infections'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum, plasma and stools'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 305}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2029-01-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-19', 'studyFirstSubmitDate': '2024-02-28', 'studyFirstSubmitQcDate': '2024-03-07', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of hospitalizations attributable to FMT', 'timeFrame': 'Week 10 and 3 years after FMT'}], 'secondaryOutcomes': [{'measure': 'Proportion of Clostridium difficile relapses', 'timeFrame': '10 weeks after FMT, and 3 years', 'description': 'In the short term: rate of occurrence of at least one recurrence of CDI within 10 weeks after FMT; In the medium term: rate of occurrence of at least one recurrence of CDI \\> 10 weeks and ≤ 3 years after FMT.'}, {'measure': 'Proportion of relapse', 'timeFrame': 'Week 10 and 3 years', 'description': 'The strains will be characterized in each center according to local methods.'}, {'measure': 'Proportion of reinfections', 'timeFrame': 'Week 10 and 3 years', 'description': 'The strains will be characterized in each center according to local methods.'}, {'measure': 'Efficacy of FMT in CDI (defined as free from relapse) at 10 weeks and 3 years according to clinical characteristics of donors', 'timeFrame': 'at 10 weeks and 3 years'}, {'measure': 'Efficacy of FMT in CDI (defined as free from relapse) at 10 weeks and 3 years according to clinical characteristics of patients', 'timeFrame': 'at 10 weeks and 3 years'}, {'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', 'timeFrame': 'at 10 weeks and 3 years'}, {'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.', 'timeFrame': 'Before and after FMT at Week 10, at Month 6 then every 6 months until Month 36'}, {'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.', 'timeFrame': 'Week 10'}, {'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.", 'timeFrame': 'before FMT and at week 10 for patients'}, {'measure': 'adverse event rate', 'timeFrame': '24hours, 10weeks, every 6 months until 3 years', 'description': 'In the short term, all adverse events occurring within 24 hours following FMT and within 10 weeks following FMT will be recorded based on both a predetermined list of events of interest as well as on an open declaration.\n\nIn the medium term, potential adverse events in the patient will be recorded every 6 months for 3 years also based on a predetermined list of events and on an open declaration.\n\nOccurrence of at least one SAE at W10 and 3 years according to (i) the clinical characteristics of the donors, (ii) the clinical characteristics of the patients, (iii) the method of preparation and administration of the fecal preparation.'}, {'measure': 'Metabolomic, immunological analysis (phenotype of peripheral blood immune cells) of the donor and the patient before and after FMT (at W10).', 'timeFrame': 'Day 0 and Week 10'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Clostridium Difficile Infection', 'Fecal microbiota transplantation'], 'conditions': ['Clostridium Difficile Infections']}, '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.\n\nThere 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.', 'detailedDescription': 'Clostridium difficile infection (CDI) is a major cause of infectious diarrhea and the most important cause of nosocomial diarrhea. For 20 years, the incidence of CDI has continued to increase. In addition, the severity of infections is also increasing (mortality: 5% in 1990 against 13.8% in 2003; complications: 6% in 1990 against 18% in 2003).\n\nRecurrent forms represent a major problem of this infection. Indeed, after a first episode, the risk of a first recurrence is around 15 to 25% and this risk then increases with each recurrence, reaching 45% then 65% after a first and second recurrence respectively. These Recurrent forms pose a real therapeutic problem, causing significant morbidity (repeated hospitalizations, time off work, etc.) and substantial mortality. Patients with CDI are 2.5 times more likely to die within 30 days of infection than uninfected patients, regardless of age or comorbidities. The mortality rate is also higher in patients with a recurrent form than in those with a single episode. Furthermore, the antibiotics usually used are only marginally effective in cases of recurrent CDI.\n\nNumerous studies, including two randomized trials, have shown that fecal microbiota transplantation (FMT), is superior to antibiotic therapy in reducing subsequent recurrences, the use of FMT in this indication appears in the most recent European and North American recommendations.\n\nCosmic-FMT cohort aims to be as representative as possible of the population of patients having FMT for CDI in the context of care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with an indication for fecal microbiota transplantation as part of the treatment for Clostridium difficile infection', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients :\n\n* Adult patient with an indication for FMT for CDI (severe refractory CDI, recurrent CDI);\n* Informed written consent\n\nDonors:\n\n* Adult (18 years or older)\n* Informed Written consent\n\nExclusion Criteria:\n\n* insufficient level of understanding of written and spoken French language'}, 'identificationModule': {'nctId': 'NCT06311006', 'acronym': 'COSMIC-FMT', 'briefTitle': 'Safety Registry of a Fecal Microbiota Transplant Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Safety Registry of a Fecal Microbiota Transplant Cohort (COSMIC-FMT)', 'orgStudyIdInfo': {'id': 'K170103J'}, 'secondaryIdInfos': [{'id': '2019-A02579-48', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': '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)'}, {'label': 'Stool donor'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75012', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Harry SOKOL, MD, PhD', 'role': 'CONTACT', 'email': 'harry.sokol@aphp.fr', 'phone': '0033 1 49 28 31 62', 'phoneExt': '+33'}], 'facility': 'Gastroenterology Department of Saint Antoine Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Harry SOKOL, MD, PhD', 'role': 'CONTACT', 'email': 'harry.sokol@aphp.fr', 'phone': '0033 1 49 28 31 62'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}