Effect of a Multi-Strain Probiotic Supplement and Lifestyle Changes on Liver Fat, Scarring, and Metabolic Health in Adults with Metabolic Dysfunction-Associated Steatotic Liver Disease MASLD

What this Trial Is About

Metabolic Dysfunction-Associated Steatotic Liver Disease MASLD is a newly defined condition, formerly known as Non-Alcoholic Fatty Liver Disease NAFLD. It involves fatty liver confirmed by imaging or biopsy along with one or more cardiometabolic risk factors such as high blood sugar, abnormal lipids, high blood pressure, or obesity. MASLD is the most common chronic liver disease worldwide, affecting about 30-40% of people. There is currently no approved medicine for MASLD, and lifestyle changes remain the main treatment. The study explores the link between gut microbiota imbalance and MASLD, considering modulation of gut bacteria as a potential therapy. This clinical trial evaluates the effects of a multi-strain probiotic supplement combined with lifestyle modification in adults with MASLD. Participants are randomly assigned to receive either the probiotic product containing specific Lactobacillus and Bifidobacterium strains or a placebo, both alongside standard lifestyle advice from a gastroenterologist. The treatment lasts for 12 weeks, during which the impact on liver fibrosis, fat accumulation, cardiometabolic risk factors, inflammation, and gut microbiota composition is studied. Participants will attend visits over 12 weeks to monitor changes using liver shear wave elastography and ultrasound, blood tests for liver enzymes, lipids, glucose, inflammatory markers, and insulin resistance measures. Researchers will also track body weight, waist circumference, and blood pressure. The study carefully monitors safety and collects data on various blood parameters to assess the probiotics effect as an adjunct therapy. Total participation duration covers the treatment period and assessments through week 12.

Impact of a Probiotic Supplementation With Lifestyle Modification on Liver Steatosis, Fibrosis, and Metabolic Health in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)