Healthy Stool Volunteer Donors for Fecal Microbiota Transplantation Trials

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-49
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

Qualifiers

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)

Informed written consent

Disqualifiers

Previous history of typhoid fever, tuberculosis and malaria

Past or current injection drug user or regular use of other drug

1st degree family history of one of the following autoimmune or inflammatory disease : inflammatory arthritis, psoriasis, multiple sclerosis, type I diabetes, spondylitis, lupus and Basedow disease

Subject prone to hemorrhoids (at least 1 event within the previous 1 year)

Trial design

Treatments tested in this trial

  • Stools donation

Treatment groups

400 Participants
are divided into 1 treatment group

Sponsors and collaborators

Assistance Publique - Hôpitaux de Paris

Lead sponsor

CRB-SAT BARM APHP.SU

Collaborator

CRSA UMRS 938

Collaborator