Clinical trial NCT04805879: 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
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Depression
Treatment Resistant Depression
Keywords: FMT
Fecal Microbiota Transplantation
Microbiome
gut brain axis
Major depression
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Cumming school of medicine
name: The W. Garfield Westin Foundation
First posted: 2021-03-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in the MADRS total score
timeFrame: from baseline (pre-intervention) to the final visit (week 13)
Secondary outcomes:
measure: Side effects as reported on the Toronto Side Effect Scale (TSES)
timeFrame: from baseline (pre-intervention) to the final visit (week 13)
measure: GI tolerability of patients with Irritable Bowel Syndrome (IBS)
timeFrame: from baseline (pre-intervention) to the final visit (week 13)
Other outcomes:
measure: To assess the effect of FMT on microbiome profile
timeFrame: from baseline (pre-intervention) to the final visit (week 13)
measure: changes in inflammatory markers (Blood)
timeFrame: from baseline (pre-intervention) to the final visit (week 13)
measure: changes in inflammatory markers (stool)
timeFrame: from baseline (pre-intervention) to the final visit (week 13)
measure: changes in serum cytokines
timeFrame: from baseline (pre-intervention) to the final visit (week 13)
measure: To examine imaging changes
timeFrame: from baseline (pre-intervention) to the final visit (week 13)
Locations:
city: Calgary
country: Canada
facility: Cumming School of Medicine, University of Calgary
state: Alberta
Study officials:
affiliation: Cumming School of Medicine, University of Calgary
name: Valerie Taylor, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: