Ignite Creation Date:
2024-07-17 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478823
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-12
Brief Title:
Healthy Stool Volunteer Donors for Fecal Microbiota Transplantation Trials
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Healthy Stool Volunteer Donors for Fecal Microbiota Transplantation Trials
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIOLONSEL
Brief 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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-A01401-42 | OTHER | None | None |