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

Last updated: November 27, 2023
Sponsor: University of Calgary
Overall Status: Active - Recruiting

Phase

2/3

Condition

Depression

Treatment

Placebo Capsules

FMT oral Capsules

Clinical Study ID

NCT04805879
REB#19-0016
  • Ages 18-65
  • All Genders

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Between 18-65 years of age: Participants should be at least 18 years old and not older than 65 years at the day ofscreening
  2. Have a primary diagnosis of MDD according to the M.I.N.I. InternationalNeuropsychiatric Interview (MINI)47
  3. Medical history suggestive of Treatment Resistant Depression (TRD). (inadequateresponse to at least 2 approved antidepressants. at least one of which is in thecurrent episode of depression)48
  4. Have been on a current treatment with a approved antidepressant at an adequate dosefor at least 8 weeks
  5. A MADRS score of ≥ 19 at screening and visit 2 Additional Inclusion Criteria:
  • Participants who will be included in the IBS-D cohort should have a confirmed diagnosisof IBS-D as indicated by the referring gastroenterologist.

Exclusion

Exclusion Criteria:

    1. Participant meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5)1Criteria for the following conditions according to the M.I.N.I: f) Substance UseDisorder within the last 3 months. *(Criteria should include Alcohol and non-alcoholsubstances except Cannabis) g) Moderate or severe Substance use disorder for Cannabisuse the last 3 months h) Active Anorexia Nervosa or Bulimia nervosa i) Schizophreniaor schizoaffective disorder j) Active suicidality 2. Regular intake of non-steroidalanti-inflammatory drugs, antibiotics, or iron supplements for medical purposes in the 3 months prior to study entry 3. Use of prebiotics or probiotics for medical purposesfor more than 2 weeks within the last 3 months 4. Clinically diagnosed chronicgastrointestinal diseases (IBD, Crohn's disease, Ulcerative colitis, Celiac disease)
  1. Conditions causing immune suppression 6. Not breastfeeding, pregnant or seeking toget pregnant during the course of this study. Be using an acceptable method of birthcontrol (implants, injectable, combined oral contraceptives, IUDs, sexual abstinenceor a vasectomized partner) 7. Reported allergy to Vancomycin or Nitazoxanide

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Placebo Capsules
Phase: 2/3
Study Start date:
March 04, 2021
Estimated Completion Date:
December 04, 2024

Study 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

Connect with a study center

  • Cumming School of Medicine, University of Calgary

    Calgary, Alberta T2N 4 Z6
    Canada

    Active - Recruiting

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