Safety Registry of a Fecal Microbiota Transplant Cohort

NCT06311006 | Recruiting

• 2 other identifiers: K170103J2019-A02579-48
• Study Type: observational
• Target: 305
• Locations: 1 country
• Sites: 1

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.

Conditions

Clostridium Difficile Infections

Keywords

Clostridium Difficile Infection; Fecal microbiota transplantation

Outcome Measures

Primary Outcomes (1)

• Proportion of hospitalizations attributable to FMT

  Week 10 and 3 years after FMT

Secondary Outcomes (11)

• Proportion of Clostridium difficile relapses

  10 weeks after FMT, and 3 years

• Proportion of relapse

  Week 10 and 3 years

• Proportion of reinfections

  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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• insufficient level of understanding of written and spoken French language

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Gastroenterology Department of Saint Antoine Hospital

Paris, 75012, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma and stools

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Harry SOKOL, MD, PhD

CONTACT

0033 1 49 28 31 62; harry.sokol@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 15, 2024
• Study Start: January 4, 2021
• Primary Completion (Estimated): January 4, 2029
• Study Completion (Estimated): January 4, 2029
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

FR (1)