Recruiting
Phase 2

Microbial Ecosystem Therapeutic-2

Sponsor:

NuBiyota

Code:

NCT04602715

Conditions

Major Depressive Disorder

Anxiety

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

MET-2

Placebo

Study Details

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

Study ID

NCT04602715

Start date

Apr 1, 2021

Status verified date

Apr, 2021

Completion date

Jun, 2021

Anticipated

Primary completion date

Jun, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

1. History of chronic diarrhea
2. Need for regular use of agents that affect gastro-intestinal (GI) motility (narcotics such as codeine or morphine, agents such as loperamide or metoclopramide)
3. Colostomy
4. Elective surgery that will require preoperative antibiotics planned within 6 months of enrolment
5. History of bariatric surgery.
6. Pregnant, breastfeeding, or planning to get pregnant in the next 6 months
7. Any condition for which, in the opinion of the investigator, the participant should be excluded from the study.
8. Current use of any antidepressant/antianxiety drug (eligible to participate after a 4-week washout period)
9. More than three depressive episodes throughout lifetime
10. Having failed an anti-depressant treatment during current depressive episode
11. Use of any antibiotic drug in the past 4 weeks (may be eligible to participate after a 1-month washout period)
12. History of alcohol or substance dependence in the past 6 months
13. Daily use of probiotic product in the past 2 weeks (may be eligible to participate after a 2-week washout period)
14. Use of any type of laxative in the last 2 weeks.
15. Consumption of products fortified in probiotics (may be eligible to participate after a 2-week washout period)
16. High suicidal risk, as measured by MADRS item 10 score more than 3
17. Current psychotic symptoms
18. Bipolar Depression
19. History of epilepsy or uncontrolled seizures
20. 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)
21. Unstable medical conditions or serious diseases/conditions (e.g. cancer, cardiovascular, renal, lung, diabetes, psychiatric illness, bleeding disorders, etc.)
22. The use of natural health products (NHP); e.g. St. John's Wort, passion flower, etc.) that affect depression
23. History of Electroconvulsive therapy (ECT)

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MET-2 20 g

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).

placebo comparator: Placebo

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).

Interventions

MET-2

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.

Placebo

Placebo Control

Primary outcome measure

  • Change in Major Depression Symptoms [ Time Frame: Baseline vs. Week 6 ]
  • Change in Anxiety Symptoms [ Time Frame: Baseline vs. Week 6 ]

Central Contacts and Locations

Central contacts

Locations

Providence Care Hospital

Recruiting

Kingston, Ontario, Canada, K7L4X3

Contacts

CAMH

Recruiting

Toronto, Ontario, Canada, M6J1H4

Contacts

More Information

Sponsor

NuBiyota

Last update posted

May 11, 2021

Last verified

Apr, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NuBiyota on 2021-05-11.