Ursodeoxycholic acid for reversing gastric intestinal metaplasia
Official title: Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia: A Multicenter, Randomized, Placebo-Controlled Trial
Run by Xijing Hospital of Digestive Diseases · NCT06610760 · Data updated 2026-11-12
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 | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 196 (estimated) |
| Sponsor | Xijing Hospital of Digestive Diseases Academic / other |
| Locations | 6 sites (Pingdingshan, Henan and 5 other locations) |
| Status | Recruiting |
| Started | November 12, 2024 |
| Main results expected | October 31, 2026 |
| Study ends | October 31, 2026 |
| Registry record updated | December 5, 2025 |
| Trial ID | NCT06610760 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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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
- Email: shiyquan@fmmu.edu.cn
- Phone: 0086 + 02984771515
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.