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Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia

NCT06610760 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2025-12-05

No results posted yet for this study

Summary

The goal of this clinical trial is to investigate the efficacy of ursodeoxycholic acid in treating gastric intestinal metaplasia in Helicobacter pylori-negative adults. It will also learn about the safety of ursodeoxycholic acid. The main questions it aims to answer are:

Does ursodeoxycholic acid promote the regression of IM in individuals without Helicobacter pylori infection? What medical problems do participants experience when taking ursodeoxycholic acid? Researchers will compare ursodeoxycholic acid to a placebo (a look-alike substance that contains no drug) to see if ursodeoxycholic acid is effective in treating gastric intestinal metaplasia.

Participants will:

Take ursodeoxycholic acid or a placebo every day for 6 months. Visit the clinic once every 4 weeks for checkups and tests.

Conditions

  • Gastric Intestinal Metaplasia

Interventions

DRUG

Ursodeoxycholic Acid

Subjects will be instructed to take one capsule (250mg) of ursodeoxycholic acid three times daily, and visit the hospital every 4 weeks for evaluation of the subjective symptoms and to receive a new supply of medication.

DRUG

Placebo

Subjects will be instructed to take one capsule (250mg) of placebo three times daily, and visit the hospital every 4 weeks for evaluation of the subjective symptoms and to receive a new supply of medication.

Sponsors & Collaborators

  • Yongquan Shi

    lead OTHER

Principal Investigators

  • Yongquan Shi, PhD · Air Force Military Medical University, China

  • Xinzhao Wang · 989 Hospital of PLA Joint Logistics Support Force

  • Kun Zhuang · Xi'an Central Hospital

  • Zhufang Ma · Hanzhong 3201 Hospital

  • Yuan Gao · Ankang Central Hospital

  • Long Zou · Shangluo Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-11-12
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • China

Study Locations

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Entities

Drugs

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 NCT06610760 on ClinicalTrials.gov