drugset / Trial / NCT06610760

Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia

NCT06610760

Phase 4 Recruiting 196 enrolled Yongquan Shi
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Ursodeoxycholic Acid Small molecule 250 mg Oral