Healthy Stool Volunteer Donors for Fecal Microbiota Transplantation Trials
NCT Number: NCT06478823
Acronym: VIOLONSEL
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gastro-Intestinal Disorder
Interventions: OTHER: Stools donation
Sponsor: Assistance Publique - Hôpitaux de Paris
Collaborators: CRB-SAT BARM APHP.SU|CRSA UMRS 938
Sex: ALL
Age: ADULT
Enrollment: 400
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07-08
Completion Date: 2030-05
Locations: LRIPH CRC-Est SAT, Paris, 75012, France

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.

Primary Outcome Measures: 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

Define among the Healthy Volunteer Donors-TMFs (HVD ) included, the number of (HVD ) having made at least 1 valid stool donation., 12 months
Secondary Outcome Measures: 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, 12 months|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., 12 months|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., 12 months|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, 5 years|Factors limiting the number of donations made by HVD per donation period of 28 days maximum, Reasons for not carrying out or no preparation stool donation: availability HVD , ability to make a donation in hospital, tolerance/acceptance of blood and nasopharyngeal samples, possibility of stool preparation at the pharmacy, biological abnormalities, criteria for transitional or permanent exclusions, 12 months|Evaluate the membership of participation of HVD, Number of periods of donations made, regularity of donations, motivation for participation in the study collected by the investigator, 5 years|Evaluate the duration of participation of HVD, Duration of participation in the study collected by the investigator, 5 years|Reasons for premature termination or non-validation of stools, Reasons for premature termination or non-validation of stools: biological, viral, bacteriological, hematological abnormalities, HVD clinical anomaly, investigator decision HVD decision in order to assess the causes of premature termination of HVD and non-validation of stool donations, 5 years|Assess the characteristics of the microbiota of valid donations, Composition of the microbiota of HVD, 5 years