Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia

Last updated: December 4, 2025
Sponsor: Yongquan Shi
Overall Status: Active - Recruiting

Phase

4

Condition

Gastric Cancer

Precancerous Condition

Treatment

Placebo

Ursodeoxycholic Acid

Clinical Study ID

NCT06610760
KY20242225-F-1
  • Ages 18-75
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • patients aged from 18 to 75 years old.

  • patients with OLGIM stage Ⅱ-Ⅳ diagnosed by upper gastrointestinal endoscopy andhistopathological examination within the last 3 months.

  • patients without Helicobacter pylori infection, including patients who hadsuccessful Helicobacter pylori eradication before enrollment.

Exclusion

Exclusion Criteria:

  • a history of regular use (defined as at least once per week) of non-steroidalanti-inflammatory drugs (NSAIDs) and/or statins.

  • a history of stomach surgery (including endoscopic submucosal dissection andendoscopic mucosal resection) or previously diagnosed malignant tumor.

  • a history of heart failure, renal failure, liver cirrhosis or chronic hepaticfailure; patients with contraindications or allergies to the drugs in this study.

  • breastfeeding or pregnancy.

  • a history of substance abuse or alcohol abuse within the past one year.

  • patients with severe mental illness.

  • refusal to undergo drug treatment.

  • refusal to sign informed consent.

Study Design

Total Participants: 196
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
November 12, 2024
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • 989 Hospital of PLA Joint Logistics Support Force

    Pingdingshan 1798827, Henan 1808520
    China

    Active - Recruiting

  • Xijing hospital

    Xi'an, Shaanxi 710032
    China

    Site Not Available

  • Ankang Central Hospital

    Ankang 1789065, Shaanxi 1796480
    China

    Active - Recruiting

  • Hanzhong 3201 Hospital

    Hanzhong 1808857, Shaanxi 1796480
    China

    Active - Recruiting

  • Shangluo Central Hospital

    Shangluo 1796068, Shaanxi 1796480
    China

    Active - Recruiting

  • Xi'an Central Hospital

    Xi'an 1790630, Shaanxi 1796480
    China

    Active - Recruiting

  • Xijing hospital

    Xi'an 1790630, Shaanxi 1796480 710032
    China

    Active - Recruiting

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