The Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People With Major Depression

NCT04602715 | Unknown Phase 2

• 1 other identifier: MET-2 301-2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

To measure the effects of Microbial Ecosystem Therapeutics (MET)-2 on symptoms of depression and anxiety using pre- and post-treatment scores for overall depression and anxiety

Conditions

Major Depressive Disorder; Anxiety

Outcome Measures

Primary Outcomes (2)

• Change in Major Depression Symptoms

  To assess subjective changes in mood from baseline to after MET-2 treatment using the Montgomery-Asberg Depression Rating Scale (10 domains given a rating from 0 to 6)

  Baseline vs. Week 6

• Change in Anxiety Symptoms

  To assess subjective changes in anxiety symptoms from baseline to after MET-2 treatment using the Hamilton Anxiety Rating Scale (14 domains given a rating on a 5 point scale)

  Baseline vs. Week 6

Study Arms (2)

MET-2 20 g

EXPERIMENTAL

Loading dose of MET-2 is administered for the first two days, followed by a regular, daily dose for the duration of the study (6 weeks total).The loading dose will consist of 5 g of MET-2 in the form of ten capsules orally on day one and on day two. The regular daily dose will consist of 1.5 g MET-2 in the form of three MET-2 capsules taken once daily, excluding days where they take the booster (same as loading dose).

Drug: MET-2

Placebo

PLACEBO COMPARATOR

Loading dose of placebo is administered for the first two days, followed by a regular, daily dose of placebo for the duration of the study (6 weeks total).The loading dose will consist of ten capsules of placebo (which match the MET-2 capsules in appearance and weight) taken orally on day one and on day two. The regular daily dose will consist of three placebo capsules taken once daily, excluding days where they take the booster (same as loading dose).

Drug: Placebo

Interventions

MET-2 DRUG

Subjects will take capsules containing MET-2 daily during the trial. There will be a loading dose at the start of dosing, and a daily dose. There will be a booster dose given at week 2 and a second booster dose taken at week 4 for those subjects who have not improved by that time.

MET-2 20 g

Placebo DRUG

Placebo Control

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Able to provide informed consent.
• Not pregnant
• Willing to participate in follow up as part of the study
• Diagnosis of Major Depressive Disorder (MDD) by the Mini-International Neuropsychiatric Interview (MINI)
• Current depressive episode with a Montgomery-Asberg Depression Rating Scale (MADRS) score of ≥15.
• Able to understand and comply with the requirements of the study
• Able to provide stool, urine, and blood samples.
• Those who do not choose to use antidepressants for moderate-severe depression.

You may not qualify if:

• History of chronic diarrhea
• Need for regular use of agents that affect gastro-intestinal (GI) motility (narcotics such as codeine or morphine, agents such as loperamide or metoclopramide)
• Colostomy
• Elective surgery that will require preoperative antibiotics planned within 6 months of enrolment
• History of bariatric surgery.
• Pregnant, breastfeeding, or planning to get pregnant in the next 6 months
• Any condition for which, in the opinion of the investigator, the participant should be excluded from the study.
• Current use of any antidepressant/antianxiety drug (eligible to participate after a 4-week washout period)
• More than three depressive episodes throughout lifetime
• Having failed an anti-depressant treatment during current depressive episode
• Use of any antibiotic drug in the past 4 weeks (may be eligible to participate after a 1-month washout period)
• History of alcohol or substance dependence in the past 6 months
• Daily use of probiotic product in the past 2 weeks (may be eligible to participate after a 2-week washout period)
• Use of any type of laxative in the last 2 weeks.
• Consumption of products fortified in probiotics (may be eligible to participate after a 2-week washout period)

Sponsors & Collaborators

• NuBiyota: lead

Study Sites (2)

Providence Care Hospital

Kingston, Ontario, K7L4X3, Canada

RECRUITING

CAMH

Toronto, Ontario, M6J1H4, Canada

RECRUITING

Related Publications (2)

• Chinna Meyyappan A, Sgarbossa C, Bromley H, Forth E, Muller DJ, Vazquez G, Cabrera C, Milev R. The Safety and Efficacy of Microbial Ecosystem Therapeutic-2 in People With Major Depression - A Phase 2, Double-Blind, Placebo-Controlled Study: Clinical Results: Innocuite et efficacite du traitement de l'ecosysteme microbien (met-2) dans la depression majeure - une etude de phase 2 a double insu controlee par placebo : resultats cliniques. Can J Psychiatry. 2025 Nov;70(11):816-823. doi: 10.1177/07067437251328270. Epub 2025 Mar 21.

  PMID: 40116713 DERIVED

• Chinna Meyyappan A, Sgarbossa C, Vazquez G, Bond DJ, Muller DJ, Milev R. The Safety and Efficacy of Microbial Ecosystem Therapeutic-2 in People With Major Depression: Protocol for a Phase 2, Double-Blind, Placebo-Controlled Study. JMIR Res Protoc. 2021 Sep 22;10(9):e31439. doi: 10.2196/31439.

  PMID: 34550085 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Anxiety Disorders

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Roumen Milev, MD/PhD

  Queens University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arthi C Meyyappan, MSc

CONTACT

647.226.2803; meyyappa@providencecare.ca

Roumen Milev, MD/PhD

CONTACT

613.544.4900; milevr@providencecare.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Hospital pharmacies will be provided with the randomization code and will dispense the appropriate medication to subjects. A fire-wall exists between the pharmacies and the investigational staff.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: two arm, randomized, placebo controlled

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 26, 2020
• Study Start: April 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: May 11, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)