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Completed

NCT Number: NCT05646784

Gut Microbiota in Mood Disorders 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 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.

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Key information

Conditions

Gut Microbiome Behavior Behavioral Symptoms Depression Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint-Joseph University

Beirut, Lebanon

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cerebiome

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Concentration of plasma inflammatory markers

    Time frame: 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 outcomes

  1. Metagenomic analysis of the gut microbiota

    Time frame: 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

  2. Depression score

    Time frame: 12 weeks of the start of the treatment

    Improvement of depression will be assessed using the MADRS tool

Sponsors and collaborators

Lead sponsor

St Joseph University, Beirut, Lebanon

Other

Collaborators

  • Lallemand Health Solutions, Canada

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 12, 2022
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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