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.
Age ≥ 18 years and < 50 years
17 kg/m² < body mass index < 30 kg/m²
Regular bowel movement defined as at least 1 stool every other day and maximum 2 stools per day
Subject with health insurance (AME excepted)
Residence of more than 2 years in the intertropics zone within the previous 5 years
Hospitalization abroad for more than 24 hours in the last 12 months (including a member of the healthy volunteers donor's entourage)
Risk factors for Creutzfeldt-Jakob disease (history: treatment with extractive growth hormone, a family case of transmissible spongiform subacute encephalopathy, surgery with opening of the dura or neurosurgery or invasive brain exploration before 1 January 1995, stay in United Kingdom for a duration greater than 1 year cumulatively between 1980 and 1996 or the presence of neurological or neuropsychiatric scalable recent clinical signs)
Previous history of typhoid fever, tuberculosis and malaria
Single group
Stools donation
Other interventionHealthy 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.
Proportion of HVD included who made at least 1 valid stool donation in the 12 months following their inclusion
A valid stool donation is a donation that complies with all the clinical and biological recommendations of the ANSM (Defining the rules of good practice relating to the collection, control, storage, traceability and transport of human stool samples as provided for in Article L. 513-11-2 of the Public Health Code. Decision of 7 April 2025.") Define among the Healthy Volunteer Donors-TMFs (HVD ) included, the number of (HVD ) having made at least 1 valid stool donation.
Proportion of "good donors": included donors having made at least 5 valid stool donations in the 12 months following their inclusion.
A valid stool donation is a donation that complies with all the clinical and biological recommendations of the ANSM Define among HVD included, "good donors" having made at least 5 valid stool donations
Description of the clinical characteristics of HVD performing stool donation
Description of clinical characteristics (average age, average BMI) of donors who made at least 1 valid stool donation within 12 months following their inclusion and comparison with those of donors who did not not having made valid donations.
Description of the lifestyle habits of HVD performing stool donation
Description of the lifestyle habits (lifestyle : profession, eating habits) of donors who made at least 1 valid stool donation within 12 months following their inclusion and comparison with those of donors who did not not having made valid donations.
Reasons for non-eligibility during the inclusion visit or during the phone screening
Description of the reasons for non-eligibility during the inclusion visit or during the phone screening (non-inclusion criteria, availability, tolerance/acceptance of blood and nasopharyngeal samples, geographical distance, compensation amount, etc.) in order to evaluate the factors limiting the eligibility of HVD
Click on the lead sponsor to view all of their trials.
Assistance Publique - Hôpitaux de Paris
Lead sponsor
CRB-SAT BARM APHP.SU
Collaborator
CRSA UMRS 938
Collaborator
