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

Depression, Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04052451
• Other study ID #: MET-2-301
• Status: Completed
• Phase: Phase 1
• Start date: May 16, 2019
• Est. completion date: May 1, 2020

Study information

• Verified date: August 2019
• Source: NuBiyota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depression, Anxiety
• Depressive Disorder

Intervention

Biological:
• MET-2
Subjects will take study medication once daily for the duration of the study

Locations

Country	Name	City	State
Canada	Providence Care Hospital	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
NuBiyota

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Week 10
Primary	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.	Week 10