Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Gastric Intestinal Metaplasia

In brief

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.

Key facts

Study ID

NCT06610760

Run by

Yongquan Shi

People needed

196

Starts

2024-11-12

Expected to finish

2026-10-31

Last updated by the study team

2025-12-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 989 Hospital of PLA Joint Logistics Support Force — Pingdingshan, Henan, China (enrolling)
• Ankang Central Hospital — Ankang, Shaanxi, China (enrolling)
• Hanzhong 3201 Hospital — Hanzhong, Shaanxi, China (enrolling)
• Shangluo Central Hospital — Shangluo, Shaanxi, China (enrolling)
• Xijing hospital — Xi'an, Shaanxi, China (enrolling)
• Xi'an Central Hospital — Xi'an, Shaanxi, China (enrolling)

Full record on ClinicalTrials.gov

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