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| Name | Class |
|---|---|
| Lallemand Health Solutions | INDUSTRY |
| McMaster University | OTHER |
This study will be an 8-week open-label pilot study examining subjective and objective changes in mood, anxiety, cognition, and sleep before and after the introduction of a probiotic supplement containing Lactobacillus helveticus and Bifidobacterium longum in 10 treatment-naïve participants diagnosed with major depressive disorder (MDD). In order to examine the full composition of the micro biome, the investigators will also be collecting and analyzing fecal samples as well as blood samples to examine changes in plasma levels of inflammatory markers, 5-HT, and tryptophan in order to look at possible underlying mechanisms of any changes seen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participant | Experimental | All participants will be experimental and receive Probio'Stick. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probio'Stick | Dietary Supplement | A combination of the probiotic strains Lactobacillus helveticus and Bifidobacterium longum |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mood | Mood will be assessed with the Montgomery-Asberg Depression Rating Scale (MADRS) with a cut-off score of 12 indicating remission. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety | Anxiety will be assessed with the Generalized Anxiety Disorder Scale (GAD-7). | 8 weeks |
| Cognition | Cognition will be assess with the Digit Symbol Substitution Test (DSST). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roumen Milev, PhD, MD | Queen's University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen's University | Kingston | Ontario | K7L 3N6 | Canada | ||
| Providence Care - Mental Health Services |
Individual participant data will not be shared.
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| 8 weeks |
| Sleep | Sleep will be assessed objectively using a polysomnogram to look at changes electrophysiological sleep architecture after 8 weeks of treatment. | 8 weeks |
| Plasma | Plasma will be analyzed to look at levels of inflammatory markers to see whether there is a decrease after 8 weeks of treatment. | 8 weeks |
| Kingston |
| Ontario |
| K7L 4X3 |
| Canada |
| D001519 |
| Behavior |