Gut Microbiome, Mood Disorders
Conditions
Keywords
Gut Microbiome, mood disorders, Lebanon, Depression
Brief 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 the inflammatory state, gut bacterial profile and the depressive state. Evaluate the effect of oral intake of a probiotic agent on plasma inflammatory markers, gut bacterial profile and depressive state in a subgroup of target patients versus a subgroup treated with placebo, in combination with conventional treatment.
Interventions
DRUGCerebiome
Evaluate the effect of oral intake of a probiotic agent on plasma inflammatory markers, gut bacterial profile and depressive state in a subgroup of target patients versus a subgroup treated with placebo
DRUGPlacebo
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 for 12 weeks
Sponsors
Lallemand Health Solutions, Canada
St Joseph University, Beirut, Lebanon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
A double-blind randomized probiotic versus placebo clinical trial will be performed on the target population under medical secured environment. A re-evaluation of the gut bacterial profile, inflammatory markers and depression scoring will be performed at the end of the study. Depression score at baseline and at the end using the same scoring test (MADRS) will be assessed
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of plasma inflammatory markers | 12 weeks of the start of the treatment | Blood samples (serum) will be used for the dosage of of markers like CRP, ILs-1, IL-6, and cortisol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metagenomic analysis of the gut microbiota | 12 weeks of the start of the treatment | 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 |
| Depression score | 12 weeks of the start of the treatment | Improvement of depression will be assessed using the MADRS tool |
Countries
Lebanon
Outcome results
None listed