Development of Microbial Therapeutics for Metabolic-associated Fatty Liver Disease: From Mechanistic Investigations to Clinical Trials
The goal of this clinical trial is to investigate the efficacy and safety of pasteurized Akkermansia muciniphila strain NTUH\_Amuc03 (pAKK NTUH\_Amuc03) in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)Patients. The main question it aims to answer is: Does pAKK NTUH\_Amuc03 trend to reduce the body weight, improve abnormal blood lipids , NASLD activity score, and HOMA-IR ? Researchers will compare pAKK NTUH\_Amuc03 to a placebo (a look-alike substance that contains no Akk) to see if pAKK NTUH\_Amuc03 works to MASLD. Participants will: 1. Take capsule with pAKK NTUH\_Amuc03 or a placebo every day for 3 months 2. Visit the clinic once every 4 weeks for checkups and tests
• Male or female subjects aged between 20 and 70 years old.
• The subject is diagnosed through FibroScan (CAP≧ 260 db/m)and meets one of below .
• the subject's BMI ≧23 kg/m² or waist ≧ 90cm (male) 80cm (Female)
• Fasting glucose≧100 mg/dL or sugar after meal ≧140 mg/dL or HbA1c≧5.7 or diagnosed type II diabetes(including under treatment or not)
• Blood pressure≧ 130/80 mmHg or under medication.
• Blood Triglycerides≧150 mg/dL or under medication.
• Blood HDL ≤ 40 mg/dL (Male) ≤ 50 mg/dL (Female) or under medication.
• If the subject is reproductive women, she should agree to take more than two ways of contraceptive methods.
• The subject is able to provide written informed consent by himself/herself and agrees to comply with all protocol requirements.
• The subject agrees to comply with the following two requirements:
⁃ comply with all follow-up visit requirements according to the trial protocol. comply with all requirement regarding fecal samples collection, storage and delivery according to the trial protocol.