Clinical trial NCT06311006: Safety Registry of a Fecal Microbiota Transplant Cohort
Official title: Safety Registry of a Fecal Microbiota Transplant Cohort (COSMIC-FMT)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Clostridium Difficile Infections
Keywords: Clostridium Difficile Infection
Fecal microbiota transplantation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 305
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with an indication for fecal microbiota transplantation as part of the treatment for Clostridium difficile infection

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.

Detailed description: 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).

Recurrent 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.

Numerous 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.

Cosmic-FMT cohort aims to be as representative as possible of the population of patients having FMT for CDI in the context of care.

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

Primary outcomes:
measure: Proportion of hospitalizations attributable to FMT
timeFrame: Week 10 and 3 years after FMT
Secondary outcomes:
measure: Proportion of Clostridium difficile relapses
timeFrame: 10 weeks after FMT, and 3 years
measure: Proportion of relapse
timeFrame: Week 10 and 3 years
measure: Proportion of reinfections
timeFrame: Week 10 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 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
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
Other outcomes:
Locations:
city: Paris
country: France
facility: Gastroenterology Department of Saint Antoine Hospital
Study officials:
References: