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Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia
Sponsor: Yongquan Shi
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
Conditions
Interventions
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.
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