Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Lallemand Health Solutions, Canada | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nassim Fares, Ph.D; HDR | Saint-Joseph University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint-Joseph University | Beirut | Lebanon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32506238 | Background | 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. | |
| 31719226 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
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
| 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 |
|
| 12 weeks of the start of the treatment |
| Depression score | Improvement of depression will be assessed using the MADRS tool | 12 weeks of the start of the treatment |
| DAS B, Nair GB. Homeostasis and dysbiosis of the gut microbiome in health and disease. J Biosci. 2019 Oct;44(5):117. |
| 32158447 | 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. |
| 30819515 | 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. |
| 8541446 | 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. |
| 34681176 | 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. |
| 32056863 | 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. |
| 29907531 | 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. |
| 34875345 | 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. |
| 29397391 | 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. |
| 20406665 | 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. |