Gut Microbiota in Mood Disorders in Lebanese Population

Pathophysiological Aspects of the Role of Inflammation and Gut Microbiota in Mood Disorders, and Their Therapeutic Implications 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.

A double-blind randomized probiotic versus placebo clinical trial will be enrolled in the target population during their hospitalization, under the supervision of the psychiatrist, and under medical secured environment. A re-evaluation of the depression scoring will be performed by the same physicians using the same scoring test (HAM-D for example).

Patients in a current episode of MDD admitted at Hotel-Dieu de France University Hospital, as determined by the Mini International Neuropsychiatric Interview (MINI) per DSM-IV criteria, and not currently taking any antidepressant medication

Second group of patients in a current episode of MDD admitted at Hotel-Dieu de France University Hospital, as determined by the Mini International Neuropsychiatric Interview (MINI) per DSM-IV criteria, and not currently taking any antidepressant medication

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, during the patient's stay in the hospital, and after his discharge, for a total duration of 12 weeks

Placebo effect: Evaluate the effect of oral intake of a placebo, on clinical and plasma inflammatory markers, in a subgroup treated with placebo, in combination with conventional treatment, during the patient's stay in the hospital, and after his discharge, for a total duration of 12 weeks

The diversity of the gut microbiota will be assessed by the 16S rRNA gene sequencing technique using PCR to target and amplify portions of the hypervariable regions (V1-V9) of the bacterial 16S rRNA gene. Amplicons from separate samples are then given molecular barcodes, pooled together, and sequenced. After sequencing, raw data is analyzed with a bioinformatics pipeline and comparison to a 16S reference database. After the reads are assigned to a phylogenetic rank, a taxonomy profile can be generated

Inclusion Criteria: Diagnosis of MDD by MINI Bipolar patients in depressive episode 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: Patients under anti-inflammatory drugs patients under immuno-suppressants Use of any type of laxative Women who are pregnant, breastfeeding, or planning to become pregnant during the trial

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