Study on the Efficacy and Safety of Berberine, Minocycline, Esomeprazole, and Colloidal Bismuth Quadruple Therapy in the Initial Treatment of Helicobacter Pylori.

Last updated: September 17, 2024
Sponsor: Xijing Hospital of Digestive Diseases
Overall Status: Active - Recruiting

Phase

4

Condition

Ulcers

Heartburn

Gastrointestinal Diseases And Disorders

Treatment

clarithromycin

Amoxicillin

Berberine

Clinical Study ID

NCT06603688
KY20232384-C-1
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The aim of this study is to evaluate the efficacy and safety of a quadruple therapy consisting of berberine hydrochloride, minocycline, esomeprazole, and colloidal bismuth tartrate for the first phase eradication of Helicobacter pylori. Assuming that the quadruple therapy of berberine hydrochloride, minocycline, esomeprazole, and colloidal bismuth tartrate is no less effective than the bismuth containing quadruple therapy of amoxicillin and clarithromycin. Patients diagnosed with Helicobacter pylori infection will be randomly assigned to one of the aforementioned treatments. During the 6-week follow-up, urea breath test, rapid urease test, or Helicobacter pylori fecal antigen test will be performed to confirm eradication.

The aim of this study is to evaluate the efficacy and safety of a quadruple therapy consisting of berberine hydrochloride, minocycline, esomeprazole, and colloidal bismuth tartrate for the first phase eradication of Helicobacter pylori. Assuming that the quadruple therapy of berberine hydrochloride, minocycline, esomeprazole, and colloidal bismuth tartrate is no less effective than the bismuth containing quadruple therapy of amoxicillin and clarithromycin. Patients diagnosed with Helicobacter pylori infection will be randomly assigned to one of the aforementioned treatments. During the 6-week follow-up, urea breath test, rapid urease test, or Helicobacter pylori fecal antigen test will be performed to confirm eradication.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age between 18~70,both gender.

  2. Patients with upper gastrointestinal symptoms and with documented H.pylori infectionwho did not receive Helicobacter pylori eradication treatment;

  3. Patients are willing to receive eradication treatment.

  4. Women of childbearing age were required to use medically acceptable contraceptivemethods during and 30 days after the trial.

Exclusion

Exclusion Criteria:

  1. Patients are excluded if they have previously used antibiotics to eradicateadequately recorded infection with H. pylori.

  2. Patients with contraindications or allergies to the study drug.

  3. Severe organ damage and complications (such as liver cirrhosis, uremia, etc.),severe or unstable cardiopulmonary or endocrine diseases.

  4. Constant use of anti-ulcer drugs ( including taking proton-pump.inhibitors(PPI)within 2 weeks before the [13C] urea breath test),antibiotics or bismuth complexes (more than 3 times /1 month before screening).

  5. Patients were diagnosed with gastroduodenal ulcer and MALTlymphoma.

  6. Pregnant or lactating women.

  7. Underwent upper gastrointestinal Surgery.

  8. Patients with moderate to severe dysplasia or high degree of intraepithelialneoplasia.

  9. Patients have symptom of dysphagia.

  10. Evidence of bleeding or iron efficiency anemia.

  11. A history of malignancy.

  12. Drug or alcohol abuse history in the past 1 year.

  13. Systemic use of corticosteroids, non steroidal anti-inflammatorydrugs,anticoagulants, platelet aggregation inhibitors (except the use of aspirin forless than 100 mg/d).

  14. Patients who has psychological problem or poor compliance.

  15. Enrolled in other clinical trials in the past 3 months.

  16. Refuse to sign informed consent.

Study Design

Total Participants: 548
Treatment Group(s): 6
Primary Treatment: clarithromycin
Phase: 4
Study Start date:
November 20, 2023
Estimated Completion Date:
December 01, 2024

Study Description

Screening: this phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing informed consent. One of urea breath test,rapid urease test or helicobacter pylori stool antigen test will be performed in addition to the baseline routine evaluations.

Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 13 and 17.

Follow-up: includes one visits. Approximately 28 days after the end of treatment. Eradication of H. Pylori will be confirmed by one of urea breath test,rapid urease test or helicobacter pylori stool antigen test.

Connect with a study center

  • Xijing Hosipital of Digestive Disease

    Xian, Shaanxi 710032
    China

    Active - Recruiting

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