NCT04805879

The Safety and Efficacy of Fecal Microbiota Transplantation in a Population With Major Depressive Disorder

A Clinical Trial to Evaluate the Safety and Efficacy of Fecal Microbiota Transplantation in a Population With Major Depressive Disorder

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 2/3, 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

Conditions

• Depression
• Treatment Resistant Depression

Interventions

Type	Name	Description
BIOLOGICAL	FMT oral Capsules	Each dose of FMT capsules consists of 20 capsules. The 20 over encapsulated capsules are derived from 100 grams of stool donated by a healthy indvidual that was screened to have no mental health issues or chronic or contagious doseases. Each capsule will contain 0.67 ml of pelleted intestinal microbes. Therefore it is considered that the 20 capsules are equivalent to 100 grams of stool
BIOLOGICAL	Placebo Capsules	Placebo Capsules that will look and weigh the same as the FMT oral capsules.

Timeline

• Start date: 2021-03-04
• Primary completion: 2024-03-04
• Completion: 2024-12-04
• First posted: 2021-03-18
• Last updated: 2023-11-28

Locations

1 site across 1 country: Canada