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Development of Microbial Therapeutics for Metabolic-associated Fatty Liver Disease: From Mechanistic Investigations to Clinical Trials

NCT06873165 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-03-12

No results posted yet for this study

Summary

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

  • Metabolic Dysfunction-Associated Steatotic Liver Disease

Interventions

DIETARY_SUPPLEMENT

Probiotics

1 capsule(with three different dosage) per day for 12 weeks

DIETARY_SUPPLEMENT

Placebo

1 capsule per day for 12weeks

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-22
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06873165 on ClinicalTrials.gov