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

November 27, 2023 updated by: Valerie Taylor, University of Calgary

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4 Z6
        • Recruiting
        • Cumming School of Medicine, University of Calgary
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 of screening

  2. Have a primary diagnosis of MDD according to the M.I.N.I. International Neuropsychiatric Interview (MINI)47
  3. Medical history suggestive of Treatment Resistant Depression (TRD). (inadequate response to at least 2 approved antidepressants. at least one of which is in the current episode of depression)48
  4. Have been on a current treatment with a approved antidepressant at an adequate dose for 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 diagnosis of IBS-D as indicated by the referring gastroenterologist.

Exclusion Criteria:

  • 1. Participant meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5)1 Criteria for the following conditions according to the M.I.N.I: f) Substance Use Disorder within the last 3 months. *(Criteria should include Alcohol and non-alcohol substances except Cannabis) g) Moderate or severe Substance use disorder for Cannabis use the last 3 months h) Active Anorexia Nervosa or Bulimia nervosa i) Schizophrenia or schizoaffective disorder j) Active suicidality 2. Regular intake of non-steroidal anti-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 purposes for more than 2 weeks within the last 3 months 4. Clinically diagnosed chronic gastrointestinal diseases (IBD, Crohn's disease, Ulcerative colitis, Celiac disease) 5. Conditions causing immune suppression 6. Not breastfeeding, pregnant or seeking to get pregnant during the course of this study. Be using an acceptable method of birth control (implants, injectable, combined oral contraceptives, IUDs, sexual abstinence or a vasectomized partner) 7. Reported allergy to Vancomycin or Nitazoxanide

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: FMT capsules

Each dose of FMT capsules consists of 20 capsules. The 20 over encapsulated capsules are derived from 100 grams of stool and each containing 0.67 ml of pelleted intestinal microbes.

PArticipants will recieve a loading dose of 60 capsules over 3 consecutive days followed by a booster dose of 20 caspules 1 month after and a second similar booster dose a month after that
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
Placebo Comparator: Placebo oral Capsules
Placebo casules are inactive capsules that look and weigh the same as the Active FMT caspules. Participants will follow the same schedule as the Active arm.
Biological: Placebo Capsules
Placebo Capsules that will look and weigh the same as the FMT oral capsules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the MADRS total score
Time Frame: from baseline (pre-intervention) to the final visit (week 13)
To evaluate the effectiveness of adjunct oral FMT as compared to placebo with currently accepted approved therapy for depression
from baseline (pre-intervention) to the final visit (week 13)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects as reported on the Toronto Side Effect Scale (TSES)
Time Frame: from baseline (pre-intervention) to the final visit (week 13)
The tolerability of FMT will be assessed using the Toronto Side effects Scale (TSES)
from baseline (pre-intervention) to the final visit (week 13)
GI tolerability of patients with Irritable Bowel Syndrome (IBS)
Time Frame: from baseline (pre-intervention) to the final visit (week 13)
GI tolerability will be assessed using the IBS Symptom Severity Scale (IBS SSS) and IBS specific Quality of Life (IBS-QoL) questionnaire
from baseline (pre-intervention) to the final visit (week 13)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the effect of FMT on microbiome profile
Time Frame: from baseline (pre-intervention) to the final visit (week 13)
Changes will be assessed using next generation sequencing and nuclear magnetic resonance (NMR) spectrometry
from baseline (pre-intervention) to the final visit (week 13)
changes in inflammatory markers (Blood)
Time Frame: from baseline (pre-intervention) to the final visit (week 13)
To study the changes in inflammatory markers (blood CRP)
from baseline (pre-intervention) to the final visit (week 13)
changes in inflammatory markers (stool)
Time Frame: from baseline (pre-intervention) to the final visit (week 13)
To study the changes in inflammatory markers (fecal calprotectin)
from baseline (pre-intervention) to the final visit (week 13)
changes in serum cytokines
Time Frame: from baseline (pre-intervention) to the final visit (week 13)
To study the changes in serum cytokines (IL-6, IL-10, IL-8, IFNγ and TNF)
from baseline (pre-intervention) to the final visit (week 13)
To examine imaging changes
Time Frame: from baseline (pre-intervention) to the final visit (week 13)
examine imaging changes via a structural and functional neuroimaging scan associated with FMT
from baseline (pre-intervention) to the final visit (week 13)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Collaborators

Cumming school of medicine
The W. Garfield Westin Foundation

Investigators

  • Principal Investigator: Valerie Taylor, MD, PhD, Cumming School of Medicine, University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2021

Primary Completion (Estimated)

March 4, 2024

Study Completion (Estimated)

December 4, 2024

Study Registration Dates

First Submitted

March 11, 2021

First Submitted That Met QC Criteria

March 16, 2021

First Posted (Actual)

March 18, 2021

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB#19-0016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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