Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia

December 4, 2025 updated by: Yongquan Shi

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

196

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Henan
      • Pingdingshan, Henan, China
        • Recruiting
        • 989 Hospital of PLA Joint Logistics Support Force
        • Contact:
    • Shaanxi
      • Ankang, Shaanxi, China
        • Recruiting
        • Ankang Central Hospital
        • Contact:
      • Hanzhong, Shaanxi, China
        • Recruiting
        • Hanzhong 3201 Hospital
        • Contact:
      • Shangluo, Shaanxi, China
        • Recruiting
        • Shangluo Central Hospital
        • Contact:
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Xijing Hospital
        • Contact:
      • Xi'an, Shaanxi, China
        • Recruiting
        • Xi'an Central Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The ursodeoxycholic acid group
Patients in the ursodeoxycholic acid group will receive oral ursodeoxycholic acid at a dosage of 250 mg three times daily for 6 months.
Drug: 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 Comparator: The placebo group
Patients in the placebo group will receive oral placebo at a dosage of 250 mg three times daily for 6 months.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 6 months
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.
From enrollment to the end of treatment at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 6 months
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.
From enrollment to the end of treatment at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yongquan Shi

Investigators

  • Study Chair: Yongquan Shi, PhD, Air Force Military Medical University, China
  • Principal Investigator: Xinzhao Wang, 989 Hospital of PLA Joint Logistics Support Force
  • Principal Investigator: Kun Zhuang, Xi'an Central Hospital
  • Principal Investigator: Zhufang Ma, Hanzhong 3201 Hospital
  • Principal Investigator: Yuan Gao, Ankang Central Hospital
  • Principal Investigator: Long Zou, Shangluo Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2024

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

September 19, 2024

First Submitted That Met QC Criteria

September 20, 2024

First Posted (Actual)

September 24, 2024

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20242225-F-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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