Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia
ConditionGastric Intestinal Metaplasia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorYongquan Shi
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Ursodeoxycholic Acid
- Placebo
Treatment groups
196 Participants
are divided into 2 treatment groupsLocations
6989 Hospital of PLA Joint Logistics Support Force PingdingshanHenan, China
Ankang Central Hospital AnkangShaanxi, China
Hanzhong 3201 Hospital HanzhongShaanxi, China
Shangluo Central Hospital ShangluoShaanxi, China
Sponsors and collaborators
Yongquan Shi
Lead sponsor
Xijing Hospital of Digestive Diseases
Sponsor institution
Source ClinicalTrials.gov