Study of Psychobiotics as Add-on Treatment for Depression in Adults with Pre-Metabolic and Metabolic Syndrome in Riyadh

What this Trial Is About

This research aims to evaluate the effects of commercial multi-strains psychobiotics supplementation when added to standard antidepressant therapy in adults with major depressive disorder MDD who also have pre-metabolic syndrome or metabolic syndrome. The study investigates whether these psychobiotics can help reduce depressive symptoms and improve metabolic syndrome components such as waist circumference, fasting plasma glucose, triglycerides, blood pressure, and HDL cholesterol levels. It also explores their impact on body weight and body mass index in this group of patients. Participants will be randomly assigned to receive either the psychobiotics supplement or a placebo daily for 12 weeks while continuing their antidepressant medication. The psychobiotics consist of nine selected probiotic strains formulated by Wincloves Ecologic Barrier and are taken twice a day in sachet form. The placebo contains similar inactive ingredients without bacteria. Weekly follow-ups will monitor adherence and any adverse effects, with a final assessment occurring four weeks after completing the intervention. During the study, participants will undergo assessments of depression, anxiety, anthropometric measurements, and metabolic syndrome components at the start, after 12 weeks of treatment, and at the follow-up visit. Laboratory tests and medical evaluations will support these measurements. The total study duration includes the 12-week intervention and a 4-week post-treatment observation, allowing researchers to measure changes in mood and metabolic health safely and thoroughly.

Effect of Probiotics "Psychobiotics" on Depression and Metabolic Syndrome in Saudi Arabia