Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia

Launched by YONGQUAN SHI · Sep 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called ursodeoxycholic acid to see if it can help reverse a condition known as gastric intestinal metaplasia, which affects the stomach lining. The trial will focus on adults who do not have a Helicobacter pylori infection, a type of bacteria that can cause stomach problems. Researchers want to find out if this medication is effective and safe for these patients. To do this, they will compare ursodeoxycholic acid to a placebo, which is a substance that looks like the medication but does not contain any active drug.

To participate, individuals need to be between 18 and 75 years old and have been diagnosed with a specific stage of gastric intestinal metaplasia based on a recent medical examination. Participants will take the medication or placebo daily for six months and will attend check-ups at the clinic every four weeks for monitoring. It's important to note that certain health conditions, such as a history of heart or liver issues, recent stomach surgery, or pregnancy, may prevent someone from joining the trial. This study is not yet recruiting participants, but it aims to provide valuable information about a potential new treatment option for this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.
• • a history of substance abuse or alcohol abuse within the past one year.
• • patients with severe mental illness.
• • refusal to undergo drug treatment.
• • refusal to sign informed consent.