Efficacy and Safety of Berberine for Gastric Intestinal Metaplasia

NCT07129460 | Not Yet Recruiting Phase 4

• 1 other identifier: KY20252248-F-1
• Study Type: interventional
• Target: 204
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to investigate the efficacy of Berberine in treating gastric intestinal metaplasia in Helicobacter pylori-negative adults. It will also learn about the safety of Berberine. The main questions it aims to answer are: Does Berberine promote the regression of IM in individuals without Helicobacter pylori infection? What medical problems do participants experience when taking Berberine? Researchers will compare Berberine to a placebo (a look-alike substance that contains no drug) to see if uBerberine is effective in treating gastric intestinal metaplasia. Participants will: TakeBerberine or a placebo every day for 6 months. Visit the clinic once every 4 weeks for checkups and tests.

Conditions

Gastric Intestinal Metaplasia

Outcome Measures

Primary Outcomes (2)

• 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.

  From enrollment to the end of treatment at 6 months

• 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.

  From enrollment to the end of treatment at 6 months

Secondary Outcomes (2)

• The regression rate of gastric atrophy based on OLGA stage in different groups.

  From enrollment to the end of treatment at 6 months

• The progression rate of gastric atrophy based on OLGA stage in different groups.

  From enrollment to the end of treatment at 6 months

Study Arms (2)

The Berberine group

EXPERIMENTAL

Patients in the Berberine group will receive oral Berberine hydrochloride at a dosage of 300 mg two times daily for 6 months

Drug: Berberine hydrochloride

The placebo group

PLACEBO COMPARATOR

Patients in the placebo group will receive oral placebo at a dosage of 300 mg two times daily for 6 months

Drug: Placebo

Interventions

Berberine hydrochloride DRUG

Subjects will be instructed to take three tablets (300mg) of Berberine hydrochloride two times daily, and visit the hospital every 4 weeks for evaluation of the subjective symptoms and to receive a new supply of medication.

The Berberine group

Placebo DRUG

Subjects will be instructed to take three tablets (300mg) of placebo two times daily, and visit the hospital every 4 weeks for evaluation of the subjective symptoms and to receive a new supply of medication.

The placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• a history of regular use (defined as at least once per week) of non-steroidal anti-inflammatory drugs (NSAIDs) and/or statins/or Metformin.
• 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.

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Central Study Contacts

Yongquan Shi Shi

CONTACT

029-84771515; shiyquan@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 19, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share