Actively Recruiting
Development of Microbial Therapeutics for Metabolic-associated Fatty Liver Disease: From Mechanistic Investigations to Clinical Trials
Led by National Taiwan University Hospital · Updated on 2025-03-12
40
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Development of Microbial Therapeutics for Metabolic-associated Fatty Liver Disease: From Mechanistic Investigations to Clinical Trials
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged between 20 and 70 years old.
- Diagnosed with MASLD by FibroScan with CAP 260 db/m and meeting at least one of the following: BMI 23 kg/m or waist circumference 70 cm (male) or 80 cm (female).
- Fasting glucose 100 mg/dL, post-meal sugar 140 mg/dL, HbA1c 5.7, or diagnosed with type II diabetes (treated or untreated).
- Blood pressure 130/80 mmHg or on medication for blood pressure.
- Blood triglycerides 150 mg/dL or on medication.
- Blood HDL 40 mg/dL (male) or 50 mg/dL (female) or on medication.
- Women of reproductive age agree to use at least two contraceptive methods.
- Able to provide written informed consent and follow all study protocol requirements.
- Agree to comply with all follow-up visits and fecal sample collection, storage, and delivery as per protocol.
You will not qualify if you...
- Pregnant or lactating women.
- Probiotics or prebiotics use within 14 days before the first visit.
- Use of antibiotics (except topical) or antifungals within 30 days before the first visit.
- Use of medications affecting study indicators within 14 days before the first visit, including steroids, immunosuppressants, anti-inflammatory drugs, and certain liver or lipid-related compounds, except stable doses of specific drugs like statins and metformin.
- Active or underlying infectious diarrhea (loose stools more than three times in 24 hours).
- Severe liver disease, liver function affecting disease, or active inflammatory bowel disease.
- Acute hepatitis with ALT > 200 U/L.
- Coronary artery disease with stent surgery in the last six months.
- Fasting glucose 300 mg/dL or HbA1c > 9%.
- Blood triglycerides 500 mg/dL.
- Participation in other investigational studies within 30 days prior to the first visit.
- Participation in body weight control programs within 60 days prior to the first visit.
- Travel abroad for 10 days within 60 days before the first visit or planned travel during the study.
- Following a special diet.
- Considered unsuitable for the trial by the investigator.
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Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taiwan, Taiwan
Actively Recruiting
Research Team
M
Ming-Shiang Wu, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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