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

NuBiyota

Status and phase: Completed; Phase 1

Conditions: Depression, Anxiety

Treatments: Biological: MET-2

Study type: Interventional

Funder types: Other

Identifiers

NCT04052451

MET-2-301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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)
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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Major Depression Disorder

Experimental group

Description:

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

Treatment:

Biological: MET-2

Generalized Anxiety Disorder

Experimental group

Description:

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

Treatment:

Biological: MET-2