Pathophysiological Aspects of the Role of Inflammation and Gut Microbiota in Mood Disorders, and Their Therapeutic Implications in Lebanese Population
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- Concentration of plasma inflammatory markers
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
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
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: Cerebiome (Drug)
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.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Concentration of plasma inflammatory markers
Time Frame: 12 weeks of the start of the treatment
Blood samples (serum) will be used for the dosage of of markers like CRP, ILs-1, IL-6, and cortisol
Secondary Outcomes
- Metagenomic analysis of the gut microbiota(12 weeks of the start of the treatment)
- Depression score(12 weeks of the start of the treatment)
Investigators
Nassim Fares
Full Professor of Physiology, head of the research lab of physiology & pathophysiology
St Joseph University, Beirut, Lebanon