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RECRUITING
NCT06610760
PHASE4

Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia

Sponsor: Yongquan Shi

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

196

Start Date

2024-11-12

Completion Date

2026-10-31

Last Updated

2025-12-05

Healthy Volunteers

No

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.

Locations (6)

989 Hospital of PLA Joint Logistics Support Force

Pingdingshan, Henan, China

Ankang Central Hospital

Ankang, Shaanxi, China

Hanzhong 3201 Hospital

Hanzhong, Shaanxi, China

Shangluo Central Hospital

Shangluo, Shaanxi, China

Xijing hospital

Xi'an, Shaanxi, China

Xi'an Central Hospital

Xi'an, Shaanxi, China