Gut Microbiota in Mood Disorders in Lebanese Population

• Status: Not yet recruiting
• Trial end date: 2023-12-29
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St Joseph University, Beirut, Lebanon
• Collaborator: Lallemand Health Solutions, Canada

Criteria

Inclusion Criteria:

• Diagnosis of MDD by 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

• Use of any sleep medication in the past 4 weeks

• 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

• 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

• Women who are pregnant, breastfeeding, or planning to become pregnant during the trial

• Immunodeficiency

• Unstable 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 study

• Taking antidepressant medication or other not-permitted treatment that cannot be safely discontinued