Clinical trial NCT05646784: Gut Microbiota in Mood Disorders in Lebanese Population
Official title: Pathophysiological Aspects of the Role of Inflammation and Gut Microbiota in Mood Disorders, and Their Therapeutic Implications in Lebanese Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gut Microbiome
Mood Disorders
Keywords: Gut Microbiome
mood disorders
Lebanon
Depression
Lead sponsor: St Joseph University, Beirut, Lebanon
Sponsor class: OTHER
Collaborators: name: Lallemand Health Solutions, Canada
First posted: 2022-12-12
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Concentration of plasma inflammatory markers
timeFrame: 12 weeks of the start of the treatment
Secondary outcomes:
measure: Metagenomic analysis of the gut microbiota
timeFrame: 12 weeks of the start of the treatment
measure: Depression score
timeFrame: 12 weeks of the start of the treatment
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Saint-Joseph University
Study officials:
affiliation: Saint-Joseph University
name: Nassim Fares, Ph.D; HDR
role: PRINCIPAL_INVESTIGATOR
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