Gut Microbiota in Mood Disorders in Lebanese Population

April 18, 2024 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 depressive patients and the inflammatory state. Evaluate the effect of oral intake of a probiotic agent, on clinical and plasma inflammatory markers, in a subgroup of target patients versus a subgroup treated with placebo, in combination with conventional treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

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 Contact

Study Locations

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

No

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cerebiome for Depressive patient
Patients in a current episode of MDD admitted at Hotel-Dieu de France University Hospital, as determined by the Mini International Neuropsychiatric Interview (MINI) per DSM-IV criteria. Outpatients followed by physicians from Hotel-Dieu de France University Hospital will also be recruited
Drug: Cerebiome
Evaluate the effect of oral intake of a probiotic agent, on clinical and plasma inflammatory markers, in a subgroup of target patients versus a subgroup treated with placebo, in combination with conventional treatment, during the patient's stay in the hospital, and after his discharge, for a total duration of 12 weeks
Placebo Comparator: Placebo for Control group
Second group of patients in a current episode of MDD admitted at Hotel-Dieu de France University Hospital, as determined by the Mini International Neuropsychiatric Interview (MINI) per DSM-IV criteria. Outpatients followed by physicians from Hotel-Dieu de France University Hospital will also be recruited
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, during the patient's stay in the hospital, and after his discharge, for a total duration of 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
plasma inflammatory markers
Time Frame: 12 weeks of the end of the treatment
Blood samples (serum) will be used for the dosage of CRP
12 weeks of the end of the treatment
plasma inflammatory markers
Time Frame: 12 weeks of the end of the treatment
Blood samples (serum) will be used for the dosage of ILs-1 and 6
12 weeks of the end of the treatment
plasma inflammatory markers
Time Frame: 12 weeks of the end of the treatment
Blood samples (serum) will be used for the dosage of INF alpha
12 weeks of the end of the treatment
plasma inflammatory markers
Time Frame: 12 weeks of the end of the treatment
Blood samples (serum) will be used for the dosage of TNF-α
12 weeks of the end of the treatment
plasma inflammatory markers
Time Frame: 12 weeks of the end of the treatment
Blood samples (serum) will be used for the dosage of kynurenine
12 weeks of the end of the treatment
plasma inflammatory markers
Time Frame: 12 weeks of the end of the treatment
Blood samples (serum) will be used for the dosage of cortisol
12 weeks of the end of the treatment
Metagenomic analysis of the gut microbiota
Time Frame: 12 weeks of the end 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 end 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 (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

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)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

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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