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

Primary Purpose

Depression, Treatment Resistant Depression

Status

Recruiting

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

FMT oral Capsules

Placebo Capsules

About this trial

This is an interventional treatment trial for Depression focused on measuring FMT, Fecal Microbiota Transplantation, Microbiome, gut brain axis, Major depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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

Sites / Locations

Cumming School of Medicine, University of CalgaryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

FMT capsules

Placebo oral Capsules

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

The tolerability of FMT will be assessed using the Toronto Side effects Scale (TSES)

GI tolerability of patients with Irritable Bowel Syndrome (IBS)

GI tolerability will be assessed using the IBS Symptom Severity Scale (IBS SSS) and IBS specific Quality of Life (IBS-QoL) questionnaire

Full Information

NCT ID

NCT04805879

First Posted

March 11, 2021

Last Updated

December 13, 2021

Sponsor

University of Calgary

Collaborators

Cumming school of medicine, The W. Garfield Westin Foundation

1. Study Identification

Unique Protocol Identification Number

NCT04805879

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Recruiting

Study Start Date

March 4, 2021 (Actual)

Primary Completion Date

March 4, 2023 (Anticipated)

Study Completion Date

March 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Calgary

Collaborators

Cumming school of medicine, The W. Garfield Westin Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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).

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Treatment Resistant Depression

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FMT capsules

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo oral Capsules

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Biological

Intervention Name(s)

FMT oral Capsules

Intervention Description

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

Intervention Name(s)

Placebo Capsules

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in the MADRS total score

Description

To evaluate the effectiveness of adjunct oral FMT as compared to placebo with currently accepted approved therapy for depression

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

The tolerability of FMT will be assessed using the Toronto Side effects Scale (TSES)

Time Frame

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

Title

GI tolerability of patients with Irritable Bowel Syndrome (IBS)

Description

GI tolerability will be assessed using the IBS Symptom Severity Scale (IBS SSS) and IBS specific Quality of Life (IBS-QoL) questionnaire

Time Frame

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

Other Pre-specified Outcome Measures:

Title

To assess the effect of FMT on microbiome profile

Description

Changes will be assessed using next generation sequencing and nuclear magnetic resonance (NMR) spectrometry

Time Frame

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

Title

changes in inflammatory markers (Blood)

Description

To study the changes in inflammatory markers (blood CRP)

Time Frame

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

Title

changes in inflammatory markers (stool)

Description

To study the changes in inflammatory markers (fecal calprotectin)

Time Frame

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

Title

changes in serum cytokines

Description

To study the changes in serum cytokines (IL-6, IL-10, IL-8, IFNγ and TNF)

Time Frame

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

Title

To examine imaging changes

Description

examine imaging changes via a structural and functional neuroimaging scan associated with FMT

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Asem Bala, BDS, MSc

Phone

403-210-7282

asem.bala@ucalgary.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Vivek Kumar, MBBS

Phone

403-210-8650

vivek.kumar@ucalgary.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Valerie Taylor, MD, PhD

Organizational Affiliation

Cumming School of Medicine, University of Calgary

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cumming School of Medicine, University of Calgary

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4 Z6

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rachel Research Coordinator

Phone

403-210-8650

fmtmddstudy@ucalgary.ca

First Name & Middle Initial & Last Name & Degree

Asem Research Manager

Phone

403-210-7282

fmtmddstudy@ucalgary.ca

12. IPD Sharing Statement

Learn more about this trial

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

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