Clinical Trial

Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia

Recruiting Phase 4
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-09-20; most recent amendment 2025-12-04.
Status change: Not Yet Recruiting → Recruiting 2025-07-01
Trial Details
NCT Number NCT06610760
Lead Sponsor Yongquan Shi
Conditions Gastric Intestinal Metaplasia
Enrollment 196 participants
Start Date 2024-11-12
Primary Completion 2026-10-31 (estimated)
Study Completion 2026-10-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-05