RecruitingPhase 4NCT06610760

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


Sponsor

Yongquan Shi

Enrollment

196 participants

Start Date

Nov 12, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called Ursodeoxycholic Acid for people with gastric intestinal metaplasia. The study is currently recruiting participants at 6 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGUrsodeoxycholic 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.

DRUGPlacebo

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

View Full Details on ClinicalTrials.gov

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NCT06610760


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