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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Ursodeoxycholic Acid
DrugSubjects will be instructed to take one capsule (250mg) of ursodeoxycholic acid three times daily, and visit the hospital every 4 weeks for evaluation of the subjective symptoms and to receive a new supply of medication.
Placebo
DrugSubjects will be instructed to take one capsule (250mg) of placebo three times daily, and visit the hospital every 4 weeks for evaluation of the subjective symptoms and to receive a new supply of medication.
Treatment groups
196 Participants
are divided into 2 treatment groupsGroup A: The ursodeoxycholic acid groupExperimental treatment 1 intervention
Group B: The placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The regression rate of gastric intestinal metaplasia based on OLGIM stage in different groups.
Regression was defined as a OLGIM stage decreased at least one grade.
Time frame
From enrollment to the end of treatment at 6 months2
The progression rate of gastric intestinal metaplasia based on OLGIM stage in different groups.
Progression was defined as a OLGIM stage increased at least one grade.
Time frame
From enrollment to the end of treatment at 6 monthsSecondary outcomes
1
The regression rate of gastric atrophy based on OLGA stage in different groups.
Regression was defined as a OLGA stage decreased at least one grade.
Time frame
From enrollment to the end of treatment at 6 months2
The progression rate of gastric atrophy based on OLGA stage in different groups.
Progression was defined as a OLGA stage increased at least one grade.
Time frame
From enrollment to the end of treatment at 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yongquan Shi
Lead sponsor
Xijing Hospital of Digestive Diseases
Sponsor institution
Source ClinicalTrials.gov