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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Clostridium Difficile Infections

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 Type: Observational
• Enrollment (Estimated): 305

Contacts and Locations

• Study Contact: Name: Harry SOKOL, MD, PhD; Phone Number: 0033 1 49 28 31 62; Email: harry.sokol@aphp.fr

Study Locations

• France
  • Paris, France, 75012
    • Recruiting
    • Gastroenterology Department of Saint Antoine Hospital
    • Contact: Harry SOKOL, MD, PhD; Phone Number: +33 0033 1 49 28 31 62; Email: harry.sokol@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patient with an indication for fecal microbiota transplantation as part of the treatment for Clostridium difficile infection

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients; 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)
Stool donor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of hospitalizations attributable to FMT	Week 10 and 3 years after FMT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Clostridium difficile relapses	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.	10 weeks after FMT, and 3 years
Proportion of relapse	The strains will be characterized in each center according to local methods.	Week 10 and 3 years
Proportion of reinfections	The strains will be characterized in each center according to local methods.	Week 10 and 3 years
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
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
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
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
adverse event rate	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.	24hours, 10weeks, every 6 months until 3 years
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Estimated): January 4, 2029
• Study Completion (Estimated): January 4, 2029

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 19, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Clostridium Difficile Infection; Fecal microbiota transplantation
• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Clostridium Infections
• Other Study ID Numbers: K170103J; 2019-A02579-48 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No