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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
400
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.
LRIPH CRC-Est SAT
Paris, France
RECRUITINGProportion 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.
Time frame: 12 months
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
Time frame: 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.
Time frame: 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.
Time frame: 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
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Time frame: 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
Time frame: 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
Time frame: 5 years
Evaluate the duration of participation of HVD
Duration of participation in the study collected by the investigator
Time frame: 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
Time frame: 5 years
Assess the characteristics of the microbiota of valid donations
Composition of the microbiota of HVD
Time frame: 5 years