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

Phase 4

Not yet recruiting

• Conditions: Gastric Intestinal Metaplasia
• Interventions: Drug: Placebo; Drug: Ursodeoxycholic Acid

• Registration Number: NCT06610760
• Lead Sponsor: Yongquan Shi

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-19
• Study First Submitted QC: 2024-09-20
• Last Update Submitted: 2024-09-20
• Study First Posted: 2024-09-24
• Last Update Posted: 2024-09-24
• Study Start: 2024-11-01
• Primary Completion: 2026-10-31
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 196

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The placebo group	Placebo	Patients in the placebo group will receive oral placebo at a dosage of 250 mg three times daily for 6 months.
The ursodeoxycholic acid group	Ursodeoxycholic Acid	Patients in the ursodeoxycholic acid group will receive oral ursodeoxycholic acid at a dosage of 250 mg three times daily for 6 months.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
The regression rate of gastric atrophy based on OLGA stage in different groups.	From enrollment to the end of treatment at 6 months	Regression was defined as a OLGA stage decreased at least one grade.
The progression rate of gastric atrophy based on OLGA stage in different groups.	From enrollment to the end of treatment at 6 months	Progression was defined as a OLGA stage increased at least one grade.