Status:

RECRUITING

Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia

Lead Sponsor:

Yongquan Shi

Conditions:

Gastric Intestinal Metaplasia

Eligibility:

All Genders

18-75 years

Phase:

PHASE4

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 sa...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

November 12 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 31 2026

Estimated Enrollment :

196 Patients enrolled

Trial Details

Trial ID

NCT06610760

Start Date

November 12 2024

End Date

October 31 2026

Last Update

December 5 2025

Active Locations (6)

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Page 1 of 2 (6 locations)

1

989 Hospital of PLA Joint Logistics Support Force

Pingdingshan, Henan, China

2

Ankang Central Hospital

Ankang, Shaanxi, China

3

Hanzhong 3201 Hospital

Hanzhong, Shaanxi, China

4

Shangluo Central Hospital

Shangluo, Shaanxi, China