NCT06478823

Healthy Stool Volunteer Donors for Fecal Microbiota Transplantation Trials

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

Currently, ANSM recommendations govern FMT (Fecal Microbiota Transplantation) in clinical trials. The collection and validation of these stool donations as part of the trials is complex and not very efficient. It therefore seems essential to identify the limiting factors and the characteristics of Healthy Volunteer Donors to optimize the number of valid stool donations.

Detailed description

If the ANSM recommendations govern FMT (Fecal Microbiota Transplantation) in clinical trials, the selection, inclusion of Healthy Volunteer Donors (HVD), then the collection and validation of these stool donations is complex and not very effective. New recommendations related to COVID-19 make this process even more complex. It therefore seems essential to identify the limiting factors and the characteristics of HVD to optimize the number of valid stool donations. Healthy voluntary donors of stools for the preparation of TMF (Healthy Volunteer Donors, -TMF) for trials to evaluate its effectiveness in various pathologies will be selected, included and followed in a common protocol (ANSM agreement obtained) in order to facilitate this entire process and pool resources. This will allow us to describe the clinical characteristics and lifestyle habits of Healthy Volunteer Donors associated with the validity of stool donations.

Conditions

• Gastro-Intestinal Disorder

Interventions

Type	Name	Description
OTHER	Stools donation	Healthy volunteer donors included in the selection process to donate stool for the preparation of a TMF as part of research projects. Donors will be followed from their selection until 6 months after their last valid stool donation.

Timeline

• Start date: 2024-07-08
• Primary completion: 2030-05-01
• Completion: 2030-05-01
• First posted: 2024-06-27
• Last updated: 2024-07-23

Locations

1 site across 1 country: France