Gut Microbiota in Mood Disorders in Lebanese Population

Mood Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05646784
• Other study ID #: CEHDF2009
• Status: Recruiting
• Phase: N/A
• Start date: January 24, 2024
• Est. completion date: May 1, 2024

Study information

• Verified date: April 2024
• Source: St Joseph University, Beirut, Lebanon
• Contact: Nassim Fares, Ph.D; HDR
• Phone: 009613131950
• Email: nassim.fares[@]usj.edu.lb
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gut Microbiome
• Mood Disorders

Intervention

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
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

Locations

Country	Name	City	State
Lebanon	Saint-Joseph University	Beirut

Sponsors (2)

Lead Sponsor	Collaborator
St Joseph University, Beirut, Lebanon	Lallemand Health Solutions, Canada

Country where clinical trial is conducted

Lebanon, 

References & 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. — View Citation

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

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. — View Citation

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. — View Citation

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. Erratum In: Biol Psychiatry. 2020 Jun 15;87(12):1083. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma inflammatory markers	Blood samples (serum) will be used for the dosage of CRP	12 weeks of the end of the treatment
Primary	plasma inflammatory markers	Blood samples (serum) will be used for the dosage of ILs-1 and 6	12 weeks of the end of the treatment
Primary	plasma inflammatory markers	Blood samples (serum) will be used for the dosage of INF alpha	12 weeks of the end of the treatment
Primary	plasma inflammatory markers	Blood samples (serum) will be used for the dosage of TNF-a	12 weeks of the end of the treatment
Primary	plasma inflammatory markers	Blood samples (serum) will be used for the dosage of kynurenine	12 weeks of the end of the treatment
Primary	plasma inflammatory markers	Blood samples (serum) will be used for the dosage of cortisol	12 weeks of the end of the treatment
Primary	Metagenomic analysis of the gut microbiota	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