Actively Recruiting
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
Eligibility Criteria
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.
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
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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