Clinical Trial of Pasteurized Akkermansia muciniphila Therapy for Metabolic Dysfunction-Associated Steatotic Liver Disease in Adults Aged 18 to 70

What this Trial Is About

Metabolic dysfunction-associated steatotic liver disease MASLD is a condition affecting about one-quarter of the global population and may lead to serious liver problems like fibrosis, cirrhosis, or liver cancer if untreated. This research evaluates the clinical effects and safety of a pasteurized probiotic strain, Akkermansia muciniphila LWHK0003 pAKKLWHK0003, which has shown promise in preclinical studies to slow MASLD progression by improving liver metabolism and gut microbiota balance. Participants will receive one of several doses of pAKKLWHK0003 or a placebo, each administered as a 400 mg capsule daily for 120 days. The study is randomized and triple-blinded to compare the effects of low, medium, and high doses of the probiotic treatment against placebo. The trial spans from enrollment through treatment, with detailed monitoring of liver health and metabolic parameters. Throughout the study, participants undergo assessments including Fibroscan measurements to evaluate liver steatosis and fibrosis, liver stiffness, and FIB-4 index over up to 52 weeks. Safety and efficacy data will be collected regularly to monitor treatment impact. The total participation period includes screening, 120 days of treatment, and follow-up to assess long-term liver outcomes under medical observation.

Developing Microbial Therapy for MASLD: From Mechanism to Clinical Validation