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

NCT ID: NCT04805879

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-04

Study Completion Date

2024-12-04

Brief Summary

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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

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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

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Depression Treatment Resistant Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

FMT oral Capsules

Intervention Type 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

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.

Group Type PLACEBO_COMPARATOR

Placebo Capsules

Intervention Type BIOLOGICAL

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

Interventions

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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

Intervention Type BIOLOGICAL

Placebo Capsules

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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


\- 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cumming school of medicine

UNKNOWN

Sponsor Role collaborator

The W. Garfield Westin Foundation

UNKNOWN

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Valerie Taylor

Head of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Valerie Taylor, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cumming School of Medicine, University of Calgary

Locations

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Cumming School of Medicine, University of Calgary

Calgary, Alberta, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Asem Bala, BDS, MSc

Role: CONTACT

[email protected]
403-210-7282

Vivek Kumar, MBBS

Role: CONTACT

[email protected]
403-210-8650

Facility Contacts

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Rachel Research Coordinator

Role: primary

[email protected]
403-210-8650

Asem Research Manager

Role: backup

[email protected]
403-210-7282

Other Identifiers

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REB#19-0016

Identifier Type: -

Identifier Source: org_study_id