The Efficacy, Safety, and Tolerability of Probiotics on the Mood and Cognition of Depressed Patients

Study Overview
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Brief Summary
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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.

Official Title
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The Efficacy, Safety, and Tolerability of Probiotics on the Mood and Cognition of Depressed Patients

Conditions
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Major Depressive Disorder, Depression, Depressive Symptoms

Intervention / Treatment
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* Dietary Supplement: Probio'Stick


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Major Depressive Disorder (MDD) by Mini International Neuropsychiatric Interview (MINI) Current depressive episode with a MADRS score of ≥ 20 Males and females between ages 18 and 65 Able to understand and comply with the requirements of the study Provision of written informed consent Exclusion Criteria: Use of any antidepressant drug Use of any antibiotic drug in the past 4 weeks (may be eligible to participate after a 1-month washout period) Use of any sleep medication in the past 4 weeks (may be eligible to participate after a 1-month washout period) Milk, yeast, or soy allergy History of alcohol or substance abuse 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 Consumption of products fortified in probiotics Severely suicidal Experiencing psychosis or bipolar episode History of epilepsy or uncontrolled seizures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participant<br>All participants will be experimental and receive Probio'Stick. | Dietary Supplement: Probio'Stick<br>* A combination of the probiotic strains Lactobacillus helveticus and Bifidobacterium longum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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). | 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 |