Gut Microbiota in Mood Disorders in Lebanese Population

May 12, 2025 updated by: Nassim Fares, St Joseph University, Beirut, Lebanon

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lebanon
      • Beirut, Lebanon
        • Saint-Joseph University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Healthy control

Healthy control not suffering from any mental condition according to the Mini International Neuropsychiatric Interview (MINI) per DSM-V criteria.

Healthy volunteers will be recruited from students at the Saint-Joseph and the Lebanese universities.
Experimental: Cerebiome for Depressive patient
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.
Drug: Cerebiome
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 Comparator: Placebo for Control group
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.
Drug: Placebo
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks of the start of the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks of the start of the treatment
Depression score
Time Frame: 12 weeks of the start of the treatment
Improvement of depression will be assessed using the MADRS tool
12 weeks of the start of the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St Joseph University, Beirut, Lebanon

Collaborators

Lallemand Health Solutions, Canada

Investigators

  • Principal Investigator: Nassim Fares, Ph.D; HDR, Saint-Joseph University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2024

Primary Completion (Actual)

January 31, 2025

Study Completion (Actual)

January 31, 2025

Study Registration Dates

First Submitted

November 22, 2022

First Submitted That Met QC Criteria

December 2, 2022

First Posted (Actual)

December 12, 2022

Study Record Updates

Last Update Posted (Actual)

May 13, 2025

Last Update Submitted That Met QC Criteria

May 12, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEHDF2009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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