Status:
COMPLETED
The Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People With Major Depression and/or Generalized Anxiety Disorder
Lead Sponsor:
NuBiyota
Conditions:
Depression, Anxiety
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 sle...
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 sle...
Eligibility Criteria
Inclusion
- Able to provide informed consent.
- Not pregnant
- Willing to participate in follow up as part of the study
- Diagnosis of MDD and/or GAD by MINI
- Current depressive episode with a MADRS score of ≥15 or Current GAD episode with GAD-7 score of ≥8.
- Able to understand and comply with the requirements of the study
- Able to provide stool and blood samples.
Exclusion
- History of chronic diarrhea
- Need for regular use of agents that affect 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
- 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)
- 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
- High suicidal risk, as measured by MADRS item 10 score more than 3 (or 4)
- 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 (Natural health products \[NHPs\]; e.g. St. John's Wort, passion flower, etc.) that affect depression
- History of Electroconvulsive therapy (ECT)
Key Trial Info
Start Date :
May 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2020
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04052451
Start Date
May 16 2019
End Date
May 1 2020
Last Update
August 11 2020
Active Locations (1)
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1
Providence Care Hospital
Kingston, Ontario, Canada, K7L 4X3