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Remedial Mechanism of Simvastatin and Ursodeoxycholic Acid in Liver Cirrhosis: Crosstalk of Bile Secretion, Gut Microbiome, and Host Immune Response

NCT07102979 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-08-07

No results posted yet for this study

Summary

The goal of this clinical trial is to learn whether simvastatin alone or in combination with ursodeoxycholic acid (UDCA) can reduce liver fibrosis, inflammation, and gut microbiota imbalance in patients with liver cirrhosis who have achieved viral eradication after hepatitis C or inactive hepatitis B.

The main questions the study aims to answer are:

Can simvastatin or UDCA reduce biomarkers of liver fibrosis and chronic inflammation?

Do these treatments improve gut microbiota composition and bile acid metabolism?

Is combination therapy more effective than either drug alone?

In this study, 120 patients with stable liver cirrhosis will be randomly assigned to one of four groups: no treatment (control), UDCA alone, simvastatin alone, or simvastatin plus UDCA. Patients will be followed for 6 months, during which stool, blood, and skin samples will be collected to assess gut microbiota, bile acid profiles, inflammatory markers, and fibrosis indicators.

A group of 30 healthy individuals without cirrhosis will also provide baseline comparisons for microbiota and bile acid profiles.

Conditions

Interventions

DRUG

Ursodeoxycholic Acid (URSO)

Ursodeoxycholic acid (UDCA) was administered orally at a dose of 10 mg/kg/day for 6 months.

DRUG

Simvastatin

Simvastatin was administered orally at a dose of 40 mg/day for 6 months.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

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 NCT07102979 on ClinicalTrials.gov