Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04805879
Status:
RECRUITING
Last Update Posted:
2023-11-28
First Post:
2021-03-11
Brief Title:
The Safety and Efficacy of Fecal Microbiota Transplantation in a Population With Major Depressive Disorder
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
A Clinical Trial to Evaluate the Safety and Efficacy of Fecal Microbiota Transplantation in a Population With Major Depressive Disorder
Status:
RECRUITING
Status Verified Date:
2023-11
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:
None
Brief Summary:
The primary goals of this proof of concept clinical trial are to determine the effectiveness safety and tolerability of oral FMT in adults with Treatment Resistant Depression TRD
Detailed Description:
This study is a phase 23 double-blinded randomized controlled trial RCT in which 80 adults with TRD being treated with an approved antidepressant medication will be assigned to either FMT capsules or identically appearing placebo capsules Participant will be followed for f for 14 weeks post FMT This extended observation period will allow us to see whether FMT leads to sustainable improvements in depression and changes in intestinal microbiome
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?:
False
Is an FDA AA801 Violation?:
None