Gut Microbiota in Mood Disorders in Lebanese Population

Not Applicable

Completed

• Conditions: Gut Microbiome; Mood Disorders
• Interventions: Drug: Cerebiome; Drug: Placebo

• Registration Number: NCT05646784
• Lead Sponsor: St Joseph University, Beirut, Lebanon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-22
• Study First Submitted QC: 2022-12-02
• Study First Posted: 2022-12-12
• Study Start: 2024-01-24
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cerebiome for Depressive patient	Cerebiome	Patients in a current episode of MDD, as determined by the Mini International Neuropsychiatric Interview (MINI) per DSM-V criteria recruited from Hôtel-Dieu de France hospital as well as from clinics in North Lebanon.
Placebo for Control group	Placebo	Second group of patients in a current episode of MDD, as determined by the Mini International Neuropsychiatric Interview (MINI) per DSM-V criteria recruited from Hôtel-Dieu de France hospital as well as from clinics in North Lebanon.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Saint-Joseph University; 🇱🇧 Beirut, Lebanon