Recruiting
Phase 2
Phase 3

Fecal Microbiota Transplantation

Sponsor:

University of Calgary

Code:

NCT04805879

Conditions

Depression

Treatment Resistant Depression

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

FMT oral Capsules

Placebo Capsules

Study Details

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

Study ID

NCT04805879

Start date

Mar 4, 2021

Status verified date

Nov, 2023

Completion date

Dec 4, 2024

Anticipated

Primary completion date

Mar 4, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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.

Interventions

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 Capsules

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

Primary outcome measure

  • Change in the MADRS total score [ Time Frame: from baseline (pre-intervention) to the final visit (week 13) ]

Central Contacts and Locations

Central contacts

Locations

Cumming School of Medicine, University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 4 Z6

Contacts

Rachel Research Coordinator

403-210-8650fmtmddstudy@ucalgary.ca

More Information

Sponsor

University of Calgary

Last update posted

Nov 28, 2023

Last verified

Nov, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2023-11-28.