Gut Microbiota in Mood Disorders in Lebanese Population

This study aims to evaluate the pathophysiological aspects of the role of inflammation and gut microbiota in mood disorders, in particular in depression, and their therapeutic implications on a cohort of the Lebanese population. Specific objective: The evaluation of probiotic intake (CEREBIOME®, Lallemand Health Solutions Inc., Mirabel, Canada) on depressive patients and the inflammatory state. Evaluate the effect of oral intake of a probiotic agent, on clinical and plasma inflammatory markers, in a subgroup of target patients versus a subgroup treated with placebo, in combination with conventional treatment.

Inclusion Criteria:Diagnosis of MDD by MINICurrent depressive episode with a MADRS score of ≥ 20Males and females between ages 18 and 65Able to understand and comply with the requirements of the studyProvision of written informed consentExclusion Criteria:Use of any antidepressant drugUse of any antibiotic drug in the past 4 weeksUse of any sleep medication in the past 4 weeksMilk, yeast, or soy allergyHistory of alcohol or substance abuse in the past 6 monthsDaily use of probiotic product in the past 2 weeksUse of any type of laxativeConsumption of products fortified in probioticsSeverely suicidalExperiencing psychosis or bipolar episodeHistory of epilepsy or uncontrolled seizuresWomen who are pregnant, breastfeeding, or planning to become pregnant during the trialImmunodeficiencyUnstable medical conditions or serious diseases/conditions (e.g., cancer, cardiovascular, renal, lung, diabetes, psychiatric illness, bleeding disorders, etc.)Use of natural health products (NHPs) that affect depression (e.g., passionflower, etc.)Electroconvulsive therapy (ECT) in the year prior to participation in the studyTaking antidepressant medication or other not-permitted treatment that cannot be safely discontinued