Gut Microbiota in Mood Disorders in Lebanese Population

Study Overview
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Brief Summary
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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.

Official Title
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Pathophysiological Aspects of the Role of Inflammation and Gut Microbiota in Mood Disorders, and Their Therapeutic Implications in Lebanese Population

Conditions
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Gut Microbiome, Mood Disorders

Intervention / Treatment
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* Drug: Cerebiome
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major depressive disorder: current depressive episode according to MINI (DSM-5) 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 Bipolar, schizophrenia, and addiction disorders Any antibiotic therapy in the past 4 weeks

Ages Eligible for Study
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Minimum Age: 18 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cerebiome for Depressive patient<br>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. Outpatients followed by physicians from Hotel-Dieu de France University Hospital will also be recruited | Drug: Cerebiome<br>* 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<br>|
| Placebo Comparator: Placebo for Control group<br>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. Outpatients followed by physicians from Hotel-Dieu de France University Hospital will also be recruited | Drug: Placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma inflammatory markers | Blood samples (serum) will be used for the dosage of CRP | 12 weeks of the end of the treatment | 
| plasma inflammatory markers | Blood samples (serum) will be used for the dosage of ILs-1 and 6 | 12 weeks of the end of the treatment | 
| plasma inflammatory markers | Blood samples (serum) will be used for the dosage of INF alpha | 12 weeks of the end of the treatment | 
| plasma inflammatory markers | Blood samples (serum) will be used for the dosage of TNF-α | 12 weeks of the end of the treatment | 
| plasma inflammatory markers | Blood samples (serum) will be used for the dosage of kynurenine | 12 weeks of the end of the treatment | 
| plasma inflammatory markers | Blood samples (serum) will be used for the dosage of cortisol | 12 weeks of the end of the treatment | 
| Metagenomic analysis of the gut microbiota | 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 | 12 weeks of the end of the treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gut Microbiome, mood disorders, Lebanon, Depression