Ursodeoxycholic acid for reversing gastric intestinal metaplasia

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

This study will test whether taking ursodeoxycholic acid for six months can reverse gastric intestinal metaplasia in adults who do not have Helicobacter pylori infection.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 196 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Xijing Hospital of Digestive Diseases (other)
• Locations: 6 sites (Pingdingshan, Henan and 5 other locations)
• Trial ID: NCT06610760 on ClinicalTrials.gov

What this trial studies

Adults aged 18–75 with OLGIM stage II–IV and no current Helicobacter pylori infection will take ursodeoxycholic acid or a matching placebo daily for six months. Participants will visit the clinic every four weeks for safety checks, medication monitoring, and laboratory tests. Endoscopic biopsies with histopathology will be used before and after treatment to measure changes in intestinal metaplasia and OLGIM stage. Adverse events will be recorded to characterize the safety profile of ursodeoxycholic acid in this population.

Who should consider this trial

Good fit: Adults aged 18–75 with OLGIM stage II–IV diagnosed within the last three months and who are Helicobacter pylori–negative (including those previously eradicated) are ideal candidates.

Not a fit: Patients with active H. pylori infection, prior gastric surgery or malignancy, significant heart/kidney/liver failure, pregnancy or breastfeeding, regular NSAID or statin use, recent substance/alcohol abuse, or severe mental illness are unlikely to be eligible or receive benefit.

Why it matters

Potential benefit: If effective, the treatment could reduce or reverse areas of gastric intestinal metaplasia and potentially lower future gastric cancer risk for affected patients.

How similar studies have performed: Use of ursodeoxycholic acid for gastric intestinal metaplasia is relatively novel with limited direct clinical data, so evidence from similar approaches is sparse and preliminary.

Eligibility criteria

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.

Where this trial is running

Pingdingshan, Henan and 5 other locations

• 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, China (RECRUITING)
• Xi'an Central Hospital — Xi'an, Shaanxi, China (RECRUITING)

Study contacts

• Principal investigator: Xinzhao Wang — 989 Hospital of PLA Joint Logistics Support Force
• Study coordinator: Yongquan Shi

Conditions: Gastric Intestinal Metaplasia