Back to results

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

Primary Purpose

Major Depressive Disorder, Anxiety

Status

Unknown status

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

MET-2

Placebo

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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)
High suicidal risk, as measured by MADRS item 10 score more than 3
Current psychotic symptoms
Bipolar Depression
History of epilepsy or uncontrolled seizures
Immunodeficiency (immuno-compromised and immuno-suppressed participants; e.g. acquired immune deficiency syndrome [AIDS], lymphoma, participants undergoing long-term corticosteroid treatment, chemotherapy and allograft participants)
Unstable medical conditions or serious diseases/conditions (e.g. cancer, cardiovascular, renal, lung, diabetes, psychiatric illness, bleeding disorders, etc.)
The use of natural health products (NHP); e.g. St. John's Wort, passion flower, etc.) that affect depression
History of Electroconvulsive therapy (ECT)

Sites / Locations

Providence Care HospitalRecruiting
CAMHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MET-2 20 g

Placebo

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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)

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT04602715

First Posted

October 9, 2020

Last Updated

May 9, 2021

Sponsor

NuBiyota

1. Study Identification

Unique Protocol Identification Number

NCT04602715

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2021 (Actual)

Primary Completion Date

June 2021 (Anticipated)

Study Completion Date

June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NuBiyota

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

Detailed Description

An eight week, randomized, placebo controlled trial to assess subjective changes in mood and anxiety symptoms from baseline to after MET-2 treatment in participants with depression, using MADRS, Hamilton Anxiety Rating Scale (HAM-A), and other mood/anxiety scales and to demonstrate a significantly higher proportion of responders in patient who were randomized to receive the active study drug compared to patients who were randomized to receive placebo.

6. Conditions and Keywords

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

Major Depressive Disorder, Anxiety

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

two arm, randomized, placebo controlled

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MET-2 20 g

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

MET-2

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo Control

Primary Outcome Measure Information:

Title

Change in Major Depression Symptoms

Description

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)

Time Frame

Baseline vs. Week 6

Title

Change in Anxiety Symptoms

Description

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)

Time Frame

Baseline vs. Week 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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) High suicidal risk, as measured by MADRS item 10 score more than 3 Current psychotic symptoms Bipolar Depression History of epilepsy or uncontrolled seizures Immunodeficiency (immuno-compromised and immuno-suppressed participants; e.g. acquired immune deficiency syndrome [AIDS], lymphoma, participants undergoing long-term corticosteroid treatment, chemotherapy and allograft participants) Unstable medical conditions or serious diseases/conditions (e.g. cancer, cardiovascular, renal, lung, diabetes, psychiatric illness, bleeding disorders, etc.) The use of natural health products (NHP); e.g. St. John's Wort, passion flower, etc.) that affect depression History of Electroconvulsive therapy (ECT)

Central Contact Person:

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

Arthi C Meyyappan, MSc

Phone

647.226.2803

meyyappa@providencecare.ca

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

Roumen Milev, MD/PhD

Phone

613.544.4900

Ext

73002

milevr@providencecare.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roumen Milev, MD/PhD

Organizational Affiliation

Queens University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Providence Care Hospital

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L4X3

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cassandra Sgarbossa, BSc

Phone

(519) 404-4326

c.sgarbossa@queensu.ca

First Name & Middle Initial & Last Name & Degree

Roumen Milev, MD, PhD

Phone

(613) 544-4900

Ext

73002

milevr@providencecare.ca

Facility Name

CAMH

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M6J1H4

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ilona Gorbovskaya, MSc

Phone

416 535-8501

Ext

30231

ilona.gorbovskaya@camh.ca

First Name & Middle Initial & Last Name & Degree

Daniel Mueller, MD/PhD

Phone

416 535-8501

Ext

30851

daniel.mueller@camh.ca

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34550085

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs