Gut Microbiota in Mood Disorders in Lebanese Population

St Joseph University, Beirut, Lebanon

Status: Completed

Conditions: Gut Microbiome; Mood Disorders

Treatments: Drug: Cerebiome; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05646784

CEHDF2009

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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73 participants in 3 patient groups, including a placebo group

Cerebiome for Depressive patient

Experimental group

Description:

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.

Treatment:

Drug: Cerebiome

Placebo for Control group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Healthy control

No Intervention group

Description:

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.