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NCT Number: NCT07129460

Efficacy and Safety of Berberine for Gastric Intestinal Metaplasia

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.

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Key information

Conditions

Gastric Intestinal Metaplasia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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/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.

Treatment and study plan

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.

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.

Primary outcomes

  1. The regression rate of gastric intestinal metaplasia based on OLGIM stage in different groups.

    Time frame: From enrollment to the end of treatment at 6 months

    Regression was defined as a OLGIM stage decreased at least one grade.

  2. The progression rate of gastric intestinal metaplasia based on OLGIM stage in different groups.

    Time frame: From enrollment to the end of treatment at 6 months

    Progression was defined as a OLGIM stage increased at least one grade.

Secondary outcomes

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

    Time frame: From enrollment to the end of treatment at 6 months

    Regression was defined as a OLGA stage decreased at least one grade.

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

    Time frame: From enrollment to the end of treatment at 6 months

    Progression was defined as a OLGA stage increased at least one grade.

Study contacts

Contact information is provided by the study sponsor or research team.

Yongquan Shi Shi

CONTACT

[email protected]

029-84771515

Sponsors and collaborators

Lead sponsor

Xijing Hospital of Digestive Diseases

Other

Registry information

Official study title

Efficacy and Safety of Berberine for Gastric Intestinal Metaplasia: a Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 19, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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