Gut Microbiota in Mood Disorders in Lebanese Population
NCT ID: NCT05646784
Last Updated: 2025-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
73 participants
INTERVENTIONAL
2024-01-24
2025-01-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
QUADRUPLE
Study Groups
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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.
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 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.
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
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.
No interventions assigned to this group
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
Yes
Sponsors
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Lallemand Health Solutions, Canada
UNKNOWN
St Joseph University, Beirut, Lebanon
OTHER
Responsible Party
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Nassim Fares
Full Professor of Physiology, head of the research lab of physiology & pathophysiology
Principal Investigators
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Nassim Fares, Ph.D; HDR
Role: PRINCIPAL_INVESTIGATOR
Saint-Joseph University
Locations
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Saint-Joseph University
Beirut, , Lebanon
Countries
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References
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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.
DAS B, Nair GB. Homeostasis and dysbiosis of the gut microbiome in health and disease. J Biosci. 2019 Oct;44(5):117.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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CEHDF2009
Identifier Type: -
Identifier Source: org_study_id
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