Testing Pasteurized Akkermansia muciniphila Capsules for Treatment of Metabolic-Associated Fatty Liver Disease in Adults

What this Trial Is About

Researchers are studying Metabolic Dysfunction-Associated Steatotic Liver Disease MASLD, a common liver condition linked to metabolic problems that affects about one-fourth of the global population. The trial aims to evaluate the safety and effectiveness of a pasteurized probiotic called Akkermansia muciniphila strain NTUHAmuc03 pAKK NTUHAmuc03 in reducing body weight, improving blood lipid levels, liver disease activity, and insulin resistance in MASLD patients. This research addresses the urgent need for treatment options since MASLD can progress to serious liver damage and currently has no FDA-approved therapies. Participants will take one capsule daily containing either a placebo or one of three different doses of pAKK NTUHAmuc03 for 12 weeks. The study includes four groups a placebo group and three groups receiving increasing doses of the probiotic. The treatment is administered orally as capsules, and the trial uses a randomized, triple-blind design to compare the effects of the probiotic with placebo. During the study, participants will visit the clinic every four weeks for checkups and tests, including assessments of gut microbiota changes, liver fibrosis, and gut permeability at baseline and after treatment periods. Researchers will monitor safety and collect stool samples as part of the protocol. The total participation lasts about 12 to 16 weeks, with follow-up assessments to measure the primary outcomes of liver and gut health.

Development of Microbial Therapeutics for Metabolic-associated Fatty Liver Disease: From Mechanistic Investigations to Clinical Trials