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
Assistance Publique - Hôpitaux de Paris
Lead sponsor
CRB-SAT BARM APHP.SU
Collaborator
CRSA UMRS 938
Collaborator