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

COMPLETEDPHASE1

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

NCT04052451•NuBiyota

View on ClinicalTrials.gov

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.

Detailed Description

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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

•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)
+10 more criteria

Locations (1)

Providence Care Hospital

Kingston, Ontario, Canada

Key Dates

Start Date

May 16, 2019

Primary Completion Date

May 1, 2020

Completion Date

May 1, 2020

Last Updated

August 11, 2020

Enrollment

ACTUAL participants

Conditions

Depression, Anxiety

Interventions

MET-2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 11, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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