NCT06610760

Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia

Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia: A Multicenter, Randomized, Placebo-Controlled Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 196 (estimated)
• Sponsor: Yongquan Shi · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-11-12
• Primary completion: 2026-10-31
• Completion: 2026-10-31
• First posted: 2024-09-24
• Last updated: 2025-12-05

Locations

6 sites across 1 country: China