Actively Recruiting
Development of Microbial Therapeutics for Metabolic Dysfunction-Associated Steatotic Liver Disease From Mechanistic Investigations to Clinical Trials
Led by Leeuwenhoek Laboratories Co. Ltd. · Updated on 2026-03-23
40
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Metabolic dysfunction-associated steatotic liver disease (MASLD) is a condition affecting about one-quarter of the global population and may lead to serious liver problems like fibrosis, cirrhosis, or liver cancer if untreated. This research evaluates the clinical effects and safety of a pasteurized probiotic strain, Akkermansia muciniphila LWHK0003 (pAKK_LWHK0003), which has shown promise in preclinical studies to slow MASLD progression by improving liver metabolism and gut microbiota balance. Participants will receive one of several doses of pAKK_LWHK0003 or a placebo, each administered as a 400 mg capsule daily for 120 days. The study is randomized and triple-blinded to compare the effects of low, medium, and high doses of the probiotic treatment against placebo. The trial spans from enrollment through treatment, with detailed monitoring of liver health and metabolic parameters. Throughout the study, participants undergo assessments including Fibroscan measurements to evaluate liver steatosis and fibrosis, liver stiffness, and FIB-4 index over up to 52 weeks. Safety and efficacy data will be collected regularly to monitor treatment impact. The total participation period includes screening, 120 days of treatment, and follow-up to assess long-term liver outcomes under medical observation.
CONDITIONS
Brief Title
Developing Microbial Therapy for MASLD: From Mechanism to Clinical Validation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fibroscan CAP measurement of at least 260 db/m
- Adults aged 18 to 70 years with metabolic dysfunction-associated steatotic liver disease
You will not qualify if you...
- Pregnant or breastfeeding women
- Use of probiotics or prebiotic-related products within 14 days before screening
- Use of antibiotics (except skin lotions) or antifungal drugs within 30 days before screening
- Use of GLP-1 receptor agonists within 6 months before screening
- Use of drugs affecting liver fat metabolism or evaluation within 14 days before screening or during the trial, unless stable for over 6 months
- Recent severe gastrointestinal infection with diarrhea within 14 days before screening
- Certain medical history or laboratory abnormalities (details not specified in source)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 120 days
Participants receive daily capsules of pasteurized Akkermansia muciniphila or placebo to evaluate effects on fatty liver in MASLD.
Regular visits during treatment as scheduled by the study team
Duration - Up to 52 weeks from enrollment
Participants are monitored for liver steatosis, fibrosis, liver stiffness, and FIB-4 index up to 52 weeks from enrollment to assess treatment effects and safety.
Visits as scheduled for outcome assessments
Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taiwan
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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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