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Gut Microbiota in Mood Disorders in Lebanese Population

Sponsor
St Joseph University, Beirut, Lebanon (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05646784
Collaborator
Lallemand Health Solutions, Canada (Other)
50
Enrollment
1
Location
2
Arms
7
Anticipated Duration (Months)
7.1
Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
A double-blind randomized probiotic versus placebo clinical trial will be enrolled in the target population during their hospitalization, under the supervision of the psychiatrist, and under medical secured environment. A re-evaluation of the depression scoring will be performed by the same physicians using the same scoring test (HAM-D for example).
Primary Purpose:
Health Services Research
Official Title:
Pathophysiological Aspects of the Role of Inflammation and Gut Microbiota in Mood Disorders, and Their Therapeutic Implications in Lebanese Population
Anticipated Study Start Date :
May 29, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 29, 2023

Arms and Interventions

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, and not currently taking any antidepressant medication

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, and not currently taking any antidepressant medication

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

Outcome Measures

Primary Outcome Measures

  1. plasma inflammatory markers [12 weeks of the end of the treatment]

    Blood samples (serum) will be used for the dosage of CRP

  2. plasma inflammatory markers [12 weeks of the end of the treatment]

    Blood samples (serum) will be used for the dosage of ILs-1 and 6

  3. plasma inflammatory markers [12 weeks of the end of the treatment]

    Blood samples (serum) will be used for the dosage of INF alpha

  4. plasma inflammatory markers [12 weeks of the end of the treatment]

    Blood samples (serum) will be used for the dosage of TNF-α

  5. plasma inflammatory markers [12 weeks of the end of the treatment]

    Blood samples (serum) will be used for the dosage of kynurenine

  6. plasma inflammatory markers [12 weeks of the end of the treatment]

    Blood samples (serum) will be used for the dosage of cortisol

  7. Metagenomic analysis of the gut microbiota [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Diagnosis of MDD by MINI

  • Current depressive episode 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:

  • Use of any antidepressant drug

  • Use of any antibiotic drug in the past 4 weeks

  • Use of any sleep medication in the past 4 weeks

  • Milk, yeast, or soy allergy

  • History of alcohol or substance abuse in the past 6 months

  • Daily use of probiotic product in the past 2 weeks

  • Use of any type of laxative

  • Consumption of products fortified in probiotics

  • Severely suicidal

  • Experiencing psychosis or bipolar episode

  • History of epilepsy or uncontrolled seizures

  • Women who are pregnant, breastfeeding, or planning to become pregnant during the trial

  • Immunodeficiency

  • Unstable medical conditions or serious diseases/conditions (e.g., cancer, cardiovascular, renal, lung, diabetes, psychiatric illness, bleeding disorders, etc.)

  • Use of natural health products (NHPs) that affect depression (e.g., passionflower, etc.)

  • Electroconvulsive therapy (ECT) in the year prior to participation in the study

  • Taking antidepressant medication or other not-permitted treatment that cannot be safely discontinued

Contacts and Locations

Locations

Site City State Country Postal Code
1 Saint-Joseph University Beirut Lebanon

Sponsors and Collaborators

  • St Joseph University, Beirut, Lebanon
  • Lallemand Health Solutions, Canada

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Nassim Fares, Full Professor of Physiology, head of the research lab of physiology & pathophysiology, St Joseph University, Beirut, Lebanon
ClinicalTrials.gov Identifier:
NCT05646784
Other Study ID Numbers:
  • CEHDF2009
First Posted:
Dec 12, 2022
Last Update Posted:
Dec 12, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nassim Fares, Full Professor of Physiology, head of the research lab of physiology & pathophysiology, St Joseph University, Beirut, Lebanon
Gut Microbiome
mood disorders
Lebanon
Depression
Additional relevant MeSH terms:
Disease
Mood Disorders

Study Results

No Results Posted as of Dec 12, 2022