Clinical trial
Pathophysiological Aspects of the Role of Inflammation and Gut Microbiota in Mood Disorders, and Their Therapeutic Implications in Lebanese Population
Name
CEHDF2009
Description
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.
Trial arms
Trial start
2024-01-24
Estimated PCD
2024-05-01
Trial end
2024-05-01
Status
Recruiting
Treatment
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
Arms:
Cerebiome for Depressive patient
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
Arms:
Placebo for Control group
Size
50
Primary endpoint
plasma inflammatory markers
12 weeks of the end of the treatment
plasma inflammatory markers
12 weeks of the end of the treatment
plasma inflammatory markers
12 weeks of the end of the treatment
plasma inflammatory markers
12 weeks of the end of the treatment
plasma inflammatory markers
12 weeks of the end of the treatment
plasma inflammatory markers
12 weeks of the end of the treatment
Metagenomic analysis of the gut microbiota
12 weeks of the end of the treatment
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'A double-blind randomized probiotic versus placebo clinical trial will be enrolled in the target population during their hospitalization, under the supervision of the psychiatrist, and under medical secured environment. A re-evaluation of the depression scoring will be performed by the same physicians using the same scoring test (HAM-D for example).', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2024-04-19
1 organization
Organization
St Joseph University