Actively Recruiting

Phase 4
Age: 18Years - 75Years
All Genders
NCT06610760

Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia

Led by Yongquan Shi · Updated on 2025-12-05

196

Participants Needed

6

Research Sites

102 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged from 18 to 75 years old.
  • Patients with OLGIM stage I-III diagnosed by upper gastrointestinal endoscopy and histopathological examination within the last 3 months.
  • Patients without Helicobacter pylori infection, including those who had successful Helicobacter pylori eradication before enrollment.
Not Eligible

You will not qualify if you...

  • History of regular use (at least once per week) of non-steroidal anti-inflammatory drugs (NSAIDs) and/or statins.
  • History of stomach surgery, including endoscopic submucosal dissection and endoscopic mucosal resection, or previously diagnosed malignant tumor.
  • History of heart failure, renal failure, liver cirrhosis, or chronic hepatic failure.
  • Contraindications or allergies to the study drugs.
  • Breastfeeding or pregnancy.
  • History of substance or alcohol abuse within the past year.
  • Severe mental illness.
  • Refusal to undergo drug treatment.
  • Refusal to sign informed consent.

AI-Screening

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Trial Site Locations

Total: 6 locations

1

989 Hospital of PLA Joint Logistics Support Force

Pingdingshan, Henan, China

Actively Recruiting

2

Ankang Central Hospital

Ankang, Shaanxi, China

Actively Recruiting

3

Hanzhong 3201 Hospital

Hanzhong, Shaanxi, China

Actively Recruiting

4

Shangluo Central Hospital

Shangluo, Shaanxi, China

Actively Recruiting

5

Xijing hospital

Xi'an, Shaanxi, China, 710032

Actively Recruiting

6

Xi'an Central Hospital

Xi'an, Shaanxi, China

Actively Recruiting

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Research Team

Y

Yongquan Shi

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia | DecenTrialz