Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• The regression rate of gastric intestinal metaplasia based on OLGIM stage in different groups. — From enrollment to the end of treatment at 6 months
  Regression was defined as a OLGIM stage decreased at least one grade.
• The progression rate of gastric intestinal metaplasia based on OLGIM stage in different groups. — From enrollment to the end of treatment at 6 months
  Progression was defined as a OLGIM stage increased at least one grade.

Trial sites (6)

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