NCT04756544

The Influence of Probiotic Supplementation on Depressive Symptoms, Inflammation and Oxidative Stress Parameters and Faecal Microbiota in Patients With Depression Depending on Metabolic Syndrome Comorbidity

he Influence of Probiotic Supplementation on Depressive Symptoms, Inflammation and Oxidative Stress Parameters and Faecal Microbiota in Patients With Depression Depending on Metabolic Syndrome Comorbidity

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Medical University of Lodz · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

The trial will be a four-arm, parallel group, prospective, randomized, double-blind, controlled design that will include 200 participants and will last 20 weeks. The probiotic preparation will contain Lactobacillus helveticus Rosell®-52, Bifidobacterium longum Rosell®-175. We will assess the level of depression, anxiety and stress, quality of life, blood pressure, body mass index and waist circumference, white blood cells count, serum levels of C-reactive protein, HDL cholesterol, triglicerides, fasting glucose, faecal microbiota composition and the level of some faecal microbiota metabolites, as well as inflammation markers and oxidative stress parameters in serum. The trial may establish a safe and easy-to-use treatment option as an adjunct in a subpopulation of depressive patients only partially responsive to pharmacologic treatment.

Conditions

• Depressive Disorder
• Depression
• Anxiety
• Stress
• Metabolic Syndrome
• NAFLD

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactobacillus helveticus Rosell®-52, Bifidobacterium longum Rosell®-175	probiotic
OTHER	placebo	placebo

Timeline

• Start date: 2020-12-17
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2021-02-16
• Last updated: 2021-02-16

Locations

1 site across 1 country: Poland