Safety Registry of a Fecal Microbiota Transplant Cohort

NCT ID: NCT06311006

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 305 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-04
• Study Completion Date: 2029-01-04

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.

Conditions

Clostridium Difficile Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

No interventions assigned to this group

Stool donor

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gastroenterology Department of Saint Antoine Hospital

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Harry SOKOL, MD, PhD

Role: CONTACT

harry.sokol@aphp.fr

0033 1 49 28 31 62

Facility Contacts

Harry SOKOL, MD, PhD

Role: primary

harry.sokol@aphp.fr

0033 1 49 28 31 62 ext. +33

Other Identifiers

2019-A02579-48

Identifier Type: OTHER

Identifier Source: secondary_id

K170103J

Identifier Type: -

Identifier Source: org_study_id