Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06610760

Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Gastric Intestinal Metaplasia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

989 Hospital of PLA Joint Logistics Support Force, Pingdingshan, Henan, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients aged from 18 to 75 years old.
  • patients with OLGIM stage Ⅱ-Ⅳ diagnosed by upper gastrointestinal endoscopy and histopathological examination within the last 3 months.
  • patients without Helicobacter pylori infection, including patients who had successful Helicobacter pylori eradication before enrollment.

Exclusion criteria

  • a history of regular use (defined as at least once per week) of non-steroidal anti-inflammatory drugs (NSAIDs) and/or statins.
  • a history of stomach surgery (including endoscopic submucosal dissection and endoscopic mucosal resection) or previously diagnosed malignant tumor.
  • a history of heart failure, renal failure, liver cirrhosis or chronic hepatic failure; 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.

Treatment and study plan

Ursodeoxycholic acid

Drug

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

Drug

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.

Primary outcomes

  1. The regression rate of gastric intestinal metaplasia based on OLGIM stage in different groups.

    Time frame: From enrollment to the end of treatment at 6 months

    Regression was defined as a OLGIM stage decreased at least one grade.

  2. The progression rate of gastric intestinal metaplasia based on OLGIM stage in different groups.

    Time frame: From enrollment to the end of treatment at 6 months

    Progression was defined as a OLGIM stage increased at least one grade.

Secondary outcomes

  1. The regression rate of gastric atrophy based on OLGA stage in different groups.

    Time frame: From enrollment to the end of treatment at 6 months

    Regression was defined as a OLGA stage decreased at least one grade.

  2. The progression rate of gastric atrophy based on OLGA stage in different groups.

    Time frame: From enrollment to the end of treatment at 6 months

    Progression was defined as a OLGA stage increased at least one grade.

Study contacts

Contact information is provided by the study sponsor or research team.

Yongquan Shi

CONTACT

[email protected]

0086 + 02984771515

Sponsors and collaborators

Lead sponsor

Yongquan Shi

Other

Registry information

Official study title

Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia: A Multicenter, Randomized, Placebo-Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 24, 2024
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.