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

NCT04805879 | Unknown Phase 2 DMC

• 1 other identifier: REB#19-0016
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Depression; Treatment Resistant Depression

Keywords

FMT; Fecal Microbiota Transplantation; Microbiome; gut brain axis; Major depression

Outcome Measures

Primary Outcomes (1)

• Change in the MADRS total score

  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 Outcomes (2)

• Side effects as reported on the Toronto Side Effect Scale (TSES)

  from baseline (pre-intervention) to the final visit (week 13)

• GI tolerability of patients with Irritable Bowel Syndrome (IBS)

  from baseline (pre-intervention) to the final visit (week 13)

Other Outcomes (5)

• To assess the effect of FMT on microbiome profile

  from baseline (pre-intervention) to the final visit (week 13)

• changes in inflammatory markers (Blood)

  from baseline (pre-intervention) to the final visit (week 13)

• changes in inflammatory markers (stool)

  from baseline (pre-intervention) to the final visit (week 13)

Study Arms (2)

FMT capsules

ACTIVE COMPARATOR

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

Placebo oral Capsules

PLACEBO COMPARATOR

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

Interventions

FMT oral Capsules BIOLOGICAL

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

FMT capsules

Placebo Capsules BIOLOGICAL

Placebo Capsules that will look and weigh the same as the FMT oral capsules.

Placebo oral Capsules

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Have a primary diagnosis of MDD according to the M.I.N.I. International Neuropsychiatric Interview (MINI)47
• 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
• Have been on a current treatment with a approved antidepressant at an adequate dose for at least 8 weeks
• A MADRS score of ≥ 19 at screening and visit 2
• \- Participants who will be included in the IBS-D cohort should have a confirmed diagnosis of IBS-D as indicated by the referring gastroenterologist.

You may not qualify if:

• \. 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

Sponsors & Collaborators

• University of Calgary: lead
• Cumming school of medicine: collaborator
• The W. Garfield Westin Foundation: collaborator

Study Sites (1)

Cumming School of Medicine, University of Calgary

Calgary, Alberta, T2N 4 Z6, Canada

RECRUITING

MeSH Terms

Conditions

Depression; Depressive Disorder, Treatment-Resistant; Depressive Disorder, Major

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Valerie Taylor, MD, PhD

  Cumming School of Medicine, University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asem Bala, BDS, MSc

CONTACT

403-210-7282; asem.bala@ucalgary.ca

Vivek Kumar, MBBS

CONTACT

403-210-8650; vivek.kumar@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Psychiatry

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 18, 2021
• Study Start: March 4, 2021
• Primary Completion: March 4, 2024
• Study Completion: December 4, 2024
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

CA (1)