Safety Registry of a Fecal Microbiota Transplant Cohort

Recruiting

• Conditions: Clostridium Difficile Infections

• Registration Number: NCT06311006
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2021-01-04
• Study First Submitted: 2024-02-28
• Study First Submitted QC: 2024-03-07
• Study First Posted: 2024-03-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-24
• Last Update Posted: 2024-12-30
• Primary Completion: 2029-01-04
• Study Completion: 2029-01-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 305

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

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Exclusion Criteria

• insufficient level of understanding of written and spoken French language

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of hospitalizations attributable to FMT	Week 10 and 3 years after FMT

Secondary Outcome Measures

Name	Time	Method
Efficacy of FMT in CDI (defined as free from relapse) at 10 weeks and 3 years according to clinical characteristics of donors	at 10 weeks and 3 years
adverse event rate	24hours, 10weeks, every 6 months until 3 years	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.; In 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.; Occurrence 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.
Metabolomic, immunological analysis (phenotype of peripheral blood immune cells) of the donor and the patient before and after FMT (at W10).	Day 0 and Week 10
Efficacy of FMT in CDI (defined as free from relapse) at 10 weeks and 3 years according to clinical characteristics of patients	at 10 weeks and 3 years
Proportion of relapse	Week 10 and 3 years	The strains will be characterized in each center according to local methods.
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.	Week 10
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.	before FMT and at week 10 for patients
Proportion of Clostridium difficile relapses	10 weeks after FMT, and 3 years	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.
Proportion of reinfections	Week 10 and 3 years	The strains will be characterized in each center according to local methods.
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	at 10 weeks and 3 years
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.	Before and after FMT at Week 10, at Month 6 then every 6 months until Month 36

Trial Locations

Locations (1)

Gastroenterology Department of Saint Antoine Hospital; 🇫🇷 Paris, France