Tests a probiotic capsule for fatty liver disease compared with placebo
Tests a pasteurized gut bacteria capsule in adults with fatty liver disease.
Plain-language title generated from the registry record
Registry title: Development of Microbial Therapeutics for Metabolic-associated Fatty Liver Disease: From Mechanistic Investigations to Clinical Trials
Key facts
- Where
- Taipei, TaiwanSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06873165, who can take part
Where in Taiwan
- National Taiwan University HospitalTaipei, TaiwanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Taiwan University Hospital
- Trial code
- NCT06873165
- Record updated
- 12 March 2025
- Original description
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:Read full original descriptionShow less
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
Inclusion: 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: 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; 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; 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; 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.