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The main objective of the study is to evaluate whether the association of the probiotic Lactobacillus helveticus to standard antidepressant will contribute to the treatment of major depression.
Patients with the diagnosis of major depression according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria will receive one daily oral dose of 1 × 10^9 colony-forming units (CFUs) of Lactobacillus helveticus or placebo for 8 weeks in addition to conventional antidepressant treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | Patients with major depression (both sexes) will receive capsules with 1 × 10^9 CFUs of Lactobacillus helveticus in addition to a conventional antidepressant treatment for 8 weeks. |
|
| Maltodextrin | Placebo Comparator | Patients with major depression (both sexes) will receive capsules of placebo (maltodextrin) in addition to a conventional antidepressant treatment for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Other | Patients with major depression (both sexes) will receive capsules with 1 × 10^9 CFUs of Lactobacillus helveticus in addition to a conventional antidepressant treatment for 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the depressive symptoms severity | Depression symptoms severity will be assessed through the Montgomery-Asberg Depression Rating Scale (MADRS) (Minimum: 0 to 6 - normal/symptom absent/ Maximum: >34 - severe depression). Higher scores mean a worse outcome. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in microbiota composition | Microbiota composition will be assessed by Real-Time qPCR. | 8 weeks |
| Changes in the serum levels of biomarkers | Inflammatory markers (adiponectin, resistin, leptin, TNF, IL6 and IL10) and neurotrophic factors (GDNF, NGF) will be assessed by enzyme-linked immunosorbent assay (ELISA). Markers will be measured in pg/ml. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio L Teixeira, PhD | Contact | +1 713 486 2555 | altexr@gmail.com | |
| Antonio Teixeira, PhD | Contact | +1 713 486 2555 | altexr@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Aline Silva de Miranda, PhD | Federal University of Minas Gerais | Study Chair |
| Érica Leandro Marciano Vieira | Federal University of Minas Gerais | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das ClÃnicas | Recruiting | Belo Horizonte | Minas Gerais | 30130-100 | Brazil |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| C008315 | maltodextrin |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Maltodextrin | Other | Patients with major depression (both sexes) will receive capsules of placebo (maltodextrin) in addition to a conventional antidepressant treatment for 8 weeks |
|
| 8 weeks |
| Change in perception of stress | Perception of stress will be assessed by Perceived Stress Scale (PSS). It is a measure of the degree to which life situations are assessed as stressful. Range from 0 to 40 with higher scores indicating worse outcome. | 8 weeks |
| Lais Bhering Martins |
| Federal University of Minas Gerais |
| Study Chair |
| D019602 |
| Food and Beverages |