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

NCT04805879 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-11-28

No results posted yet for this study

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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • Cumming school of medicine

    collaborator UNKNOWN

  • The W. Garfield Westin Foundation

    collaborator UNKNOWN

  • University of Calgary

    lead OTHER

Principal Investigators

  • Valerie Taylor, MD, PhD · Cumming School of Medicine, University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-04
Primary Completion
2024-03-04
Completion
2024-12-04

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04805879 on ClinicalTrials.gov