RecruitingNot ApplicableNCT06873165

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

Sponsor

National Taiwan University Hospital

Enrollment

40 participants

Start Date

Jan 22, 2025

Study Type

INTERVENTIONAL

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria11

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 Criteria16

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.