Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia: A Multicenter, Randomized, Placebo-Controlled Trial

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Ankang Central Hospital
RECRUITING
Ankang
Hanzhong 3201 Hospital
RECRUITING
Hanzhong
989 Hospital of PLA Joint Logistics Support Force
RECRUITING
Pingdingshan
Shangluo Central Hospital
RECRUITING
Shangluo
Xi'an Central Hospital
RECRUITING
Xi'an
Xijing hospital
RECRUITING
Xi'an
Contact Information
Primary
Yongquan Shi
shiyquan@fmmu.edu.cn
0086 + 02984771515
Time Frame
Start Date: 2024-11-12
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 196
Treatments
Experimental: The ursodeoxycholic acid group
Patients in the ursodeoxycholic acid group will receive oral ursodeoxycholic acid at a dosage of 250 mg three times daily for 6 months.
Placebo_comparator: The placebo group
Patients in the placebo group will receive oral placebo at a dosage of 250 mg three times daily for 6 months.
Related Therapeutic Areas
Sponsors
Leads: Yongquan Shi

This content was sourced from clinicaltrials.gov