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CompletedNCT04052451Updated Aug 11, 2020

The Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People With Major Depression and/or Generalized Anxiety Disorder

A Phase 1 interventional study of MET-2 in Depression, Anxiety, sponsored by NuBiyota. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-08-11.

Sponsored by NuBiyota · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
21
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
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Study summary

This study will measure the effects of MET-2 on symptoms of depression and anxiety using pre- and post-treatment scores for overall depression and anxiety and other symptoms of depression, such as sleep and anhedonia.

Read the detailed description

This study will measure the effects of MET-2 on symptoms of depression and anxiety using pre- and post-treatment scores for overall depression and anxiety and other symptoms of depression, such as sleep and anhedonia.

02

Conditions studied

03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 21 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

NuBiyota is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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 MDD and/or GAD by MINI
  5. Current depressive episode with a MADRS score of ≥15 or Current GAD episode with GAD-7 score of ≥8.
  6. Able to understand and comply with the requirements of the study
  7. Able to provide stool and blood samples.

Exclusion criteria

Exclusion Criteria:

  1. History of chronic diarrhea
  2. Need for regular use of agents that affect 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. Pregnant, breastfeeding, or planning to get pregnant in the next 6 months
  6. Any condition for which, in the opinion of the investigator, the participant should be excluded from the study.
  7. Current use of any antidepressant/antianxiety drug (eligible to participate after a 4-week washout period)
  8. Use of any antibiotic drug in the past 4 weeks (may be eligible to participate after a 1-month washout period)
  9. History of alcohol or substance dependence in the past 6 months
  10. Daily use of probiotic product in the past 2 weeks (may be eligible to participate after a 2-week washout period)
  11. Use of any type of laxative in the last 2 weeks.
  12. Consumption of products fortified in probiotics
  13. High suicidal risk, as measured by MADRS item 10 score more than 3 (or 4)
  14. Current psychotic symptoms
  15. Bipolar Depression
  16. History of epilepsy or uncontrolled seizures
  17. 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)
  18. Unstable medical conditions or serious diseases/conditions (e.g. cancer, cardiovascular, renal, lung, diabetes, psychiatric illness, bleeding disorders, etc.)
  19. The use of natural health products (Natural health products [NHPs]; e.g. St. John's Wort, passion flower, etc.) that affect depression
  20. History of Electroconvulsive therapy (ECT)
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    Major Depression Disorder

    MET-2 will be given to subjects with major depression disorder and its effect on mood will be measured

    Biological: MET-2

  • Experimental
    Generalized Anxiety Disorder

    MET-2 will be given to subjects with generalized anxiety disorder and its effect on mood will be measured

    Biological: MET-2

Interventions

  • BiologicalMET-2

    Subjects will take study medication once daily for the duration of the study

06

What researchers measure

Primary outcomes

  1. Montgomery-Asberg Depression Rating Scale (MADRS)

    The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders

    Time frame: Week 10

  2. Generalized Anxiety Disorder - 7 (GAD-7)

    The GAD-7 is a seven domain, self-reported questionnaire for screening and assessing severity of generalized anxiety disorder.

    Time frame: Week 10

07

Study locations

1 site
  • Providence Care Hospital
    Kingston, Ontario K7L 4X3, Canada
08

References and documents

Publications

  • Chinna Meyyappan A, Forth E, Milev R. Microbial Ecosystem Therapeutic-2 Intervention in People With Major Depressive Disorder and Generalized Anxiety Disorder: Phase 1, Open-Label Study. Interact J Med Res. 2022 Jan 21;11(1):e32234. doi: 10.2196/32234. PubMed 35060914 ↗

Individual participant data

Plan to share: No — IPD will not be shared with other researchers.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04052451
Lead sponsor
NuBiyota
Responsible party
Sponsor
First posted
Aug 9, 2019
Start date
May 16, 2019
Primary completion
May 1, 2020
Completion
May 1, 2020
Last update
Aug 11, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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