Back to resultsThe Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People With Major Depression and/or Generalized Anxiety Disorder
Primary Purpose
Depression, Anxiety
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
MET-2
Sponsored by
About this trial
This is an interventional treatment trial for Depression, Anxiety
Eligibility Criteria
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)
Sites / Locations
- Providence Care Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Major Depression Disorder
Generalized Anxiety Disorder
Arm Description
MET-2 will be given to subjects with major depression disorder and its effect on mood will be measured
MET-2 will be given to subjects with generalized anxiety disorder and its effect on mood will be measured
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04052451
Brief Title
The Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People With Major Depression and/or Generalized Anxiety Disorder
Official Title
The Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People With Major Depression and/or Generalized Anxiety Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 16, 2019 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NuBiyota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 sleep and anhedonia.
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 sleep and anhedonia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
This is an open label study with one arm for subjects diagnosed with major depression disorder and one arm for subjects diagnosed with generalized anxiety disorder
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Major Depression Disorder
Arm Type
Experimental
Arm Description
MET-2 will be given to subjects with major depression disorder and its effect on mood will be measured
Arm Title
Generalized Anxiety Disorder
Arm Type
Experimental
Arm Description
MET-2 will be given to subjects with generalized anxiety disorder and its effect on mood will be measured
Intervention Type
Biological
Intervention Name(s)
MET-2
Intervention Description
Subjects will take study medication once daily for the duration of the study
Primary Outcome Measure Information:
Title
Montgomery-Asberg Depression Rating Scale (MADRS)
Description
The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders
Time Frame
Week 10
Title
Generalized Anxiety Disorder - 7 (GAD-7)
Description
The GAD-7 is a seven domain, self-reported questionnaire for screening and assessing severity of generalized anxiety disorder.
Time Frame
Week 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Providence Care Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 4X3
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared with other researchers.
Citations:
PubMed Identifier
35060914
Citation
Chinna Meyyappan A, Forth E, Milev R. Microbial Ecosystem Therapeutic-2 Intervention in People With Major Depressive Disorder and Generalized Anxiety Disorder: Phase 1, Open-Label Study. Interact J Med Res. 2022 Jan 21;11(1):e32234. doi: 10.2196/32234.
Results Reference
derived
Learn more about this trial
The Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People With Major Depression and/or Generalized Anxiety Disorder
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