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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
196
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.
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.
989 Hospital of PLA Joint Logistics Support Force
Pingdingshan, Henan, China
RECRUITINGAnkang Central Hospital
Ankang, Shaanxi, China
RECRUITINGHanzhong 3201 Hospital
Hanzhong, Shaanxi, China
RECRUITINGShangluo Central Hospital
Shangluo, Shaanxi, China
RECRUITINGXijing hospital
Xi'an, Shaanxi, China
RECRUITINGXi'an Central Hospital
Xi'an, Shaanxi, China
RECRUITINGThe regression rate of gastric intestinal metaplasia based on OLGIM stage in different groups.
Regression was defined as a OLGIM stage decreased at least one grade.
Time frame: From enrollment to the end of treatment at 6 months
The progression rate of gastric intestinal metaplasia based on OLGIM stage in different groups.
Progression was defined as a OLGIM stage increased at least one grade.
Time frame: From enrollment to the end of treatment at 6 months
The regression rate of gastric atrophy based on OLGA stage in different groups.
Regression was defined as a OLGA stage decreased at least one grade.
Time frame: From enrollment to the end of treatment at 6 months
The progression rate of gastric atrophy based on OLGA stage in different groups.
Progression was defined as a OLGA stage increased at least one grade.
Time frame: From enrollment to the end of treatment at 6 months
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