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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), a common liver condition linked to metabolic problems that affects about one-fourth of the global population. The trial aims to evaluate the safety and effectiveness of a pasteurized probiotic called Akkermansia muciniphila strain NTUH_Amuc03 (pAKK NTUH_Amuc03) in reducing body weight, improving blood lipid levels, liver disease activity, and insulin resistance in MASLD patients. This research addresses the urgent need for treatment options since MASLD can progress to serious liver damage and currently has no FDA-approved therapies. Participants will take one capsule daily containing either a placebo or one of three different doses of pAKK NTUH_Amuc03 for 12 weeks. The study includes four groups: a placebo group and three groups receiving increasing doses of the probiotic. The treatment is administered orally as capsules, and the trial uses a randomized, triple-blind design to compare the effects of the probiotic with placebo. During the study, participants will visit the clinic every four weeks for checkups and tests, including assessments of gut microbiota changes, liver fibrosis, and gut permeability at baseline and after treatment periods. Researchers will monitor safety and collect stool samples as part of the protocol. The total participation lasts about 12 to 16 weeks, with follow-up assessments to measure the primary outcomes of liver and gut health.
CONDITIONS
Brief 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.
- Diagnosis of MASLD through FibroScan with CAP score of 260 dB/m or higher.
- Body mass index (BMI) of 23 kg/m² or higher or waist circumference at least 90 cm (male) or 80 cm (female).
- Fasting glucose of 100 mg/dL or higher, post-meal sugar of 140 mg/dL or higher, HbA1c of 5.7 or higher, or diagnosed type II diabetes.
- Blood pressure of 130/80 mmHg or higher or currently under medication.
- Blood triglycerides of 150 mg/dL or higher or currently under medication.
- Blood HDL of 40 mg/dL or lower (male) or 50 mg/dL or lower (female) or currently under medication.
- Reproductive women must agree to use more than two contraceptive methods.
- Ability to provide written informed consent and comply with all protocol requirements.
- Agree to comply with follow-up visits and fecal sample collection, storage, and delivery as per protocol.
You will not qualify if you...
- Pregnant or lactating individuals.
- Use of probiotics or prebiotics within 14 days prior to the first visit.
- Use of antibiotics (excluding topical) or antifungals within 30 days prior to the first visit.
- Use of medications affecting evaluation markers within 14 days prior to the first visit, except for certain allowed drugs if dosage stable for over six months.
- Active or underlying infectious diarrhea with loose stools more than three times in 24 hours.
- Diagnosis of severe or injury hepatic disease, liver function affecting disease, or active inflammatory bowel disease.
- Acute hepatitis caused by viruses or other causes with ALT over 200 U/L.
- Coronary artery disease with arterial stent surgery within the last six months.
- Fasting glucose 300 mg/dL or higher or HbA1c above 9%.
- Blood triglycerides 500 mg/dL or higher.
- Participation in other investigational studies within 30 days prior to the first visit.
- Participation in a body weight control plan within 60 days prior to the first visit.
- Travel abroad for 10 days within 60 days prior to the first visit or plans to travel during the study.
- Following a special diet.
- Considered unsuitable for the trial by the investigator.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants take 1 capsule of probiotics or placebo daily for 12 weeks to evaluate the efficacy and safety of the microbial therapeutic for MASLD.
Weekly visits for up to 12 weeks
Duration - 4 weeks
Participants are monitored for continued effects and safety assessments after completing treatment.
1 follow-up visit
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.
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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