The Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People With Major Depression
NCT ID: NCT04602715
Last Updated: 2021-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2021-04-01
2021-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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).
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
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).
Placebo
Placebo Control
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
45 Years
ALL
No
Sponsors
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NuBiyota
OTHER
Responsible Party
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Principal Investigators
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Roumen Milev, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
Queens University
Locations
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Providence Care Hospital
Kingston, Ontario, Canada
CAMH
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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 Mar 21:7067437251328270. doi: 10.1177/07067437251328270. Online ahead of print.
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.
Other Identifiers
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MET-2 301-2
Identifier Type: -
Identifier Source: org_study_id
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