Recruiting PHASE1 Metabolic Dysfunction-Associated Steatotic Liver Disease

New treatment option for Metabolic Dysfunction-Associated Steatotic Liver Disease

Official title Developing Microbial Therapy for MASLD: From Mechanism to Clinical Validation

ClinicalTrials.gov ID: NCT07488975

What this study is testing

What is Pasteurized Akkermansia muciniphila LWHK0003_low dose?

Pasteurized Akkermansia muciniphila LWHK0003_low dose is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for metabolic dysfunction-associated steatotic liver disease.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
Metabolic dysfunction-associated steatotic liver disease (MASLD), redefined in 2020, is an improved diagnostic standard evolved from non-alcoholic fatty liver disease (NAFLD), emphasizing the correlation between hepatic steatosis and metabolic dysfunction. Compared to NAFLD, which relies on exclusion-based diagnosis, MASLD criteria enhance population homogeneity in studies and accommodate patients with coexisting liver diseases, thereby improving the efficiency and relevance of drug development.
  • Phase 1: an early, usually small safety study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 70

You may be able to join if

  • Fibroscan,CAP ≧ 260db/m

You likely can't join if

  • A. Pregnant women or women who are breastfeeding. B. Use of probiotics and prebiotic-related products (including yogurt, yogurt, Yakult, etc.) within...
  • C. Patients who have used antibiotics (except skin lotions) or antifungal drugs within 30 days before the screening visit.
  • D. Use of glucagon-like peptide-1 receptor agonists (GLP1-RAs) within six months prior to the screening visit.
  • E. Use of drugs that may affect the evaluation index within 14 days before the screening visit, during the screening visit, or during the planned...
  • F. Those who have had severe gastrointestinal infection diarrhea symptoms within 14 days before the screening visit (more than three watery stools in...
  • G. Have the following medical history or laboratory abnormalities:

The study team makes the final eligibility decision.

Where it's taking place

  • Taipei, Taiwan

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.