Study of Gut Microbiotas Role in Producing Amino Acid Metabolites in Adults with Metabolic Dysfunction-Associated Steatotic Liver Disease MASLD

What this Trial Is About

Metabolic dysfunction-associated steatotic liver disease MASLD is a common liver condition ranging from simple fat buildup to more serious liver inflammation called metabolic dysfunction-associated steatohepatitis MASH. MASLD affects about one in three adults, especially those with obesity or type 2 diabetes. Research shows that the gut microbiota and its metabolites play an important role in the development and progression of MASLD, highlighting the gut-liver axis as a key area of study. This trial explores the production of amino acid-derived metabolites by the gut microbiota in MASLD patients to better understand these interactions. Participants include adults aged 18 to 80 years with confirmed MASLD and associated cardiometabolic risk factors, as well as healthy volunteers without liver or cardiometabolic diseases. The study involves collecting stool samples, dietary assessments, and blood and urine samples. MASLD patients will have these procedures alongside their routine clinical care, while healthy volunteers will participate only for research purposes. Researchers will analyze stool cultures and plasma concentrations of specific metabolites such as N-acetyl-phenylalanine NAPA and other aromatic amino acid-derived compounds. Participants provide stool samples collected at home and return them promptly for analysis. Blood samples are taken to measure metabolite levels, and dietary habits are assessed. Researchers will study the concentration of metabolites in stool cultures and plasma, as well as the gut microbiota composition. The main outcome is the concentration of NAPA in stool culture medium within 30 days after sample collection. Participation lasts through the sample collection and data analysis phases, with no additional treatment or long-term follow-up described.

Assessment of Gut Microbiota-Derived Amino Acid Metabolite Production in Patients With MASLD