Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia

NCT06610760 | Recruiting Phase 4

• 1 other identifier: KY20242225-F-1
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Gastric Intestinal Metaplasia

Outcome Measures

Primary Outcomes (2)

• The 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.

  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.

  From enrollment to the end of treatment at 6 months

Secondary Outcomes (2)

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

  From enrollment to the end of treatment at 6 months

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

  From enrollment to the end of treatment at 6 months

Study Arms (2)

The ursodeoxycholic acid group

EXPERIMENTAL

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

The placebo group

PLACEBO COMPARATOR

Patients in the placebo group will receive oral placebo at a dosage of 250 mg three times daily for 6 months.

Drug: Placebo

Interventions

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.

The ursodeoxycholic acid group

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.

The placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yongquan Shi: lead

Study Sites (6)

989 Hospital of PLA Joint Logistics Support Force

Pingdingshan, Henan, China

RECRUITING

Ankang Central Hospital

Ankang, Shaanxi, China

RECRUITING

Hanzhong 3201 Hospital

Hanzhong, Shaanxi, China

RECRUITING

Shangluo Central Hospital

Shangluo, Shaanxi, China

RECRUITING

Xijing hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

Xi'an Central Hospital

Xi'an, Shaanxi, China

RECRUITING

MeSH Terms

Interventions

Ursodeoxycholic Acid

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Officials

• Yongquan Shi, PhD

  Air Force Military Medical University, China

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongquan Shi

CONTACT

0086 + 02984771515; shiyquan@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 24, 2024
• Study Start: November 12, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)