Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-30 @ 6:07 AM
Study NCT ID:
NCT04052451
Status:
COMPLETED
Last Update Posted:
2020-08-11
First Post:
2019-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People With Major Depression and/or Generalized Anxiety Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-10', 'studyFirstSubmitDate': '2019-08-08', 'studyFirstSubmitQcDate': '2019-08-08', 'lastUpdatePostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Montgomery-Asberg Depression Rating Scale (MADRS)', 'timeFrame': 'Week 10', 'description': 'The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders'}, {'measure': 'Generalized Anxiety Disorder - 7 (GAD-7)', 'timeFrame': 'Week 10', 'description': 'The GAD-7 is a seven domain, self-reported questionnaire for screening and assessing severity of generalized anxiety disorder.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression, Anxiety']}, 'referencesModule': {'references': [{'pmid': '35060914', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Able to provide informed consent.\n2. Not pregnant\n3. Willing to participate in follow up as part of the study\n4. Diagnosis of MDD and/or GAD by MINI\n5. Current depressive episode with a MADRS score of ≥15 or Current GAD episode with GAD-7 score of ≥8.\n6. Able to understand and comply with the requirements of the study\n7. Able to provide stool and blood samples.\n\nExclusion Criteria:\n\n1. History of chronic diarrhea\n2. Need for regular use of agents that affect GI motility (narcotics such as codeine or morphine, agents such as loperamide or metoclopramide)\n3. Colostomy\n4. Elective surgery that will require preoperative antibiotics planned within 6 months of enrolment\n5. Pregnant, breastfeeding, or planning to get pregnant in the next 6 months\n6. Any condition for which, in the opinion of the investigator, the participant should be excluded from the study.\n7. Current use of any antidepressant/antianxiety drug (eligible to participate after a 4-week washout period)\n8. Use of any antibiotic drug in the past 4 weeks (may be eligible to participate after a 1-month washout period)\n9. History of alcohol or substance dependence in the past 6 months\n10. Daily use of probiotic product in the past 2 weeks (may be eligible to participate after a 2-week washout period)\n11. Use of any type of laxative in the last 2 weeks.\n12. Consumption of products fortified in probiotics\n13. High suicidal risk, as measured by MADRS item 10 score more than 3 (or 4)\n14. Current psychotic symptoms\n15. Bipolar Depression\n16. History of epilepsy or uncontrolled seizures\n17. 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)\n18. Unstable medical conditions or serious diseases/conditions (e.g. cancer, cardiovascular, renal, lung, diabetes, psychiatric illness, bleeding disorders, etc.)\n19. The use of natural health products (Natural health products \\[NHPs\\]; e.g. St. John's Wort, passion flower, etc.) that affect depression\n20. History of Electroconvulsive therapy (ECT)"}, 'identificationModule': {'nctId': 'NCT04052451', 'briefTitle': 'The Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People With Major Depression and/or Generalized Anxiety Disorder', 'organization': {'class': 'OTHER', 'fullName': 'NuBiyota'}, 'officialTitle': 'The Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People With Major Depression and/or Generalized Anxiety Disorder', 'orgStudyIdInfo': {'id': 'MET-2-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Major Depression Disorder', 'description': 'MET-2 will be given to subjects with major depression disorder and its effect on mood will be measured', 'interventionNames': ['Biological: MET-2']}, {'type': 'EXPERIMENTAL', 'label': 'Generalized Anxiety Disorder', 'description': 'MET-2 will be given to subjects with generalized anxiety disorder and its effect on mood will be measured', 'interventionNames': ['Biological: MET-2']}], 'interventions': [{'name': 'MET-2', 'type': 'BIOLOGICAL', 'description': 'Subjects will take study medication once daily for the duration of the study', 'armGroupLabels': ['Generalized Anxiety Disorder', 'Major Depression Disorder']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K7L 4X3', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Providence Care Hospital', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NuBiyota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}