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

Summary

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

Eligibility

Inclusion Criteria:

* 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.

Exclusion Criteria:

* The subject is pregnant or lactating.
* 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 has a clinically significant, currently active or underlying diarrhea (loose stools more than three times in 24 hours) of infectious etiologies.
* The subject who has been diagnosed a severe/injury hepatic disease, disease affecting liver function, active inflammatory bowel disease.
* Acute hepatitis caused by viruses or other causes and ALT \> 200 U/L.
* Coronary artery disease with arterial stent surgery in half year.
* Fasting glucose≥ 300 mg/dl or HbA1c\>9%.
* Blood triglyceride≥ 500 mg/dl.
* 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.
* The subject is special diet.
* The subject is considered by the investigator as not suitable for the trial.

Conditions2

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