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

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.

Inclusion criteria

• 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 criteria

• 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)