Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia

Yongquan Shi

Status and phase: Enrolling; Phase 4

Conditions: Gastric Intestinal Metaplasia

Treatments: Drug: Ursodeoxycholic Acid; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06610760

KY20242225-F-1

Details and patient eligibility

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.

Enrollment: 196 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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196 participants in 2 patient groups, including a placebo group

The ursodeoxycholic acid group

Experimental group

Description:

Patients in the ursodeoxycholic acid group will receive oral ursodeoxycholic acid at a dosage of 250 mg three times daily for 6 months.

Treatment:

Drug: Ursodeoxycholic Acid

The placebo group

Placebo Comparator group

Description:

Patients in the placebo group will receive oral placebo at a dosage of 250 mg three times daily for 6 months.

Treatment:

Drug: Placebo