Gut Microbiota in Mood Disorders in Lebanese Population

NCT05646784 | Completed

• 1 other identifier: CEHDF2009
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Gut Microbiome; Mood Disorders

Keywords

Gut Microbiome; mood disorders; Lebanon; Depression

Outcome Measures

Primary Outcomes (1)

• Concentration of plasma inflammatory markers

  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 Outcomes (2)

• Metagenomic analysis of the gut microbiota

  12 weeks of the start of the treatment

• Depression score

  12 weeks of the start of the treatment

Study Arms (3)

Cerebiome for Depressive patient

EXPERIMENTAL

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

Placebo for Control group

PLACEBO COMPARATOR

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

Healthy control

NO INTERVENTION

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.

Interventions

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

Cerebiome for Depressive patient

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

Placebo for Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St Joseph University, Beirut, Lebanon: lead
• Lallemand Health Solutions, Canada: collaborator

Study Sites (1)

Saint-Joseph University

Beirut, Lebanon

Location

Related Publications (11)

• Capuco A, Urits I, Hasoon J, Chun R, Gerald B, Wang JK, Ngo AL, Simopoulos T, Kaye AD, Colontonio MM, Parker-Actlis TQ, Fuller MC, Viswanath O. Gut Microbiome Dysbiosis and Depression: a Comprehensive Review. Curr Pain Headache Rep. 2020 Jun 6;24(7):36. doi: 10.1007/s11916-020-00871-x.

  PMID: 32506238 BACKGROUND

• DAS B, Nair GB. Homeostasis and dysbiosis of the gut microbiome in health and disease. J Biosci. 2019 Oct;44(5):117.

  PMID: 31719226 BACKGROUND

• Kim JK, Lee KE, Lee SA, Jang HM, Kim DH. Interplay Between Human Gut Bacteria Escherichia coli and Lactobacillus mucosae in the Occurrence of Neuropsychiatric Disorders in Mice. Front Immunol. 2020 Feb 25;11:273. doi: 10.3389/fimmu.2020.00273. eCollection 2020.

  PMID: 32158447 BACKGROUND

• Lamers F, Milaneschi Y, Smit JH, Schoevers RA, Wittenberg G, Penninx BWJH. Longitudinal Association Between Depression and Inflammatory Markers: Results From the Netherlands Study of Depression and Anxiety. Biol Psychiatry. 2019 May 15;85(10):829-837. doi: 10.1016/j.biopsych.2018.12.020. Epub 2019 Jan 9.

  PMID: 30819515 BACKGROUND

• Karle IL. Flexibility in peptide molecules and restraints imposed by hydrogen bonds, the Aib residue, and core inserts. Biopolymers. 1996;40(1):157-80. doi: 10.1002/(sici)1097-0282(1996)40:13.0.co;2-v.

  PMID: 8541446 BACKGROUND

• Misera A, Liskiewicz P, Loniewski I, Skonieczna-Zydecka K, Samochowiec J. Effect of Psychobiotics on Psychometric Tests and Inflammatory Markers in Major Depressive Disorder: Meta-Analysis of Randomized Controlled Trials with Meta-Regression. Pharmaceuticals (Basel). 2021 Sep 23;14(10):952. doi: 10.3390/ph14100952.

  PMID: 34681176 BACKGROUND

• Sanada K, Nakajima S, Kurokawa S, Barcelo-Soler A, Ikuse D, Hirata A, Yoshizawa A, Tomizawa Y, Salas-Valero M, Noda Y, Mimura M, Iwanami A, Kishimoto T. Gut microbiota and major depressive disorder: A systematic review and meta-analysis. J Affect Disord. 2020 Apr 1;266:1-13. doi: 10.1016/j.jad.2020.01.102. Epub 2020 Jan 23.

  PMID: 32056863 BACKGROUND

• Sarkar A, Harty S, Lehto SM, Moeller AH, Dinan TG, Dunbar RIM, Cryan JF, Burnet PWJ. The Microbiome in Psychology and Cognitive Neuroscience. Trends Cogn Sci. 2018 Jul;22(7):611-636. doi: 10.1016/j.tics.2018.04.006. Epub 2018 Jun 12.

  PMID: 29907531 BACKGROUND

• Tian P, Chen Y, Zhu H, Wang L, Qian X, Zou R, Zhao J, Zhang H, Qian L, Wang Q, Wang G, Chen W. Bifidobacterium breve CCFM1025 attenuates major depression disorder via regulating gut microbiome and tryptophan metabolism: A randomized clinical trial. Brain Behav Immun. 2022 Feb;100:233-241. doi: 10.1016/j.bbi.2021.11.023. Epub 2021 Dec 4.

  PMID: 34875345 BACKGROUND

• Winter G, Hart RA, Charlesworth RPG, Sharpley CF. Gut microbiome and depression: what we know and what we need to know. Rev Neurosci. 2018 Aug 28;29(6):629-643. doi: 10.1515/revneuro-2017-0072.

  PMID: 29397391 BACKGROUND

• Zunszain PA, Anacker C, Cattaneo A, Carvalho LA, Pariante CM. Glucocorticoids, cytokines and brain abnormalities in depression. Prog Neuropsychopharmacol Biol Psychiatry. 2011 Apr 29;35(3):722-9. doi: 10.1016/j.pnpbp.2010.04.011. Epub 2010 Apr 18.

  PMID: 20406665 BACKGROUND

MeSH Terms

Conditions

Mood Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Nassim Fares, Ph.D; HDR

  Saint-Joseph University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A double-blind randomized probiotic versus placebo clinical trial will be performed on the target population under medical secured environment. A re-evaluation of the gut bacterial profile, inflammatory markers and depression scoring will be performed at the end of the study. Depression score at baseline and at the end using the same scoring test (MADRS) will be assessed
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Physiology, head of the research lab of physiology & pathophysiology

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 12, 2022
• Study Start: January 24, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)