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

Prior treatment

• The subject has received probiotics or prebiotics 14 days prior to visit 1.
• The subject has received any antibiotic (excluding topical agents) or antifungals within 30 days prior to visit 1.
• The subject has received medication affecting evaluating indicators 14 days prior to visit 1, including steroids, immunosuppressant or anti-inflammation drugs hepatitis and lipid, metabolism related compounds, but excluding the following medicines: Statins, Fibrates, Silymarin, Thiazolidinediones, Metformin, Fibrate, Cholestyramine, Ezetimibe, Orlistat, SGLT2i and GLP1-RAs.
  • If the above-mentioned drugs are used continuously for more than six months and the dosage is not changed during the trial,this situation is accepted.
• The subject currently is participating in studies involving other investigational drugs, medical devices, functional foods, or cosmetic within 30 days prior to visit 1.
• The subject has participated in body weight control plan within 60 days prior to visit 1.
• The subject has been aboard for 10 days within 60 days prior to visit 1, or plans to go aboard during this study.

Other illness

• The subject who has been diagnosed a severe/injury hepatic disease, disease affecting liver function, active inflammatory bowel disease.
• Coronary artery disease with arterial stent surgery in half year.

Lab values

• Acute hepatitis caused by viruses or other causes and ALT \> 200 U/L.
• Fasting glucose≥ 300 mg/dl or HbA1c\>9%.
• Blood triglyceride≥ 500 mg/dl.

Other

• The subject is pregnant or lactating.
• The subject has a clinically significant, currently active or underlying diarrhea (loose stools more than three times in 24 hours) of infectious etiologies.
• The subject is special diet.
• The subject is considered by the investigator as not suitable for the trial.

• 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.