Helicobacter Pylori Eradication With Berberine Plus Amoxicillin Triple Therapy Versus Bismuth-containing Quadruple Therapy

Last updated: January 29, 2023
Sponsor: Xijing Hospital of Digestive Diseases
Overall Status: Completed

Phase

4

Condition

Heartburn (Pediatric)

Gastrointestinal Diseases And Disorders

Gastric Cancer

Treatment

N/A

Clinical Study ID

NCT04697186
KY20202119
  • Ages 18-70
  • All Genders

Study Summary

This study aims at evaluating efficacy and safety of berberine hydrochloride, amoxicillin and rabeprazole triple therapy versus bismuth-containing quadruple therapy(amoxicillin, clarithromycin, rabeprazole and bismuth) in the first eradication treatment of H. pylori. It is hypothesized that berberinehydrochloride, amoxicillin and rabeprazole triple therapy is non-inferior to bismuth-containing quadruple therapy. Patients diagnosed with H. pylori infection will be randomly divided into one of the above treatments. At week 6 follow-up visits, a urea breath test,rapid urease test or helicobacter pylori stool 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 eradicate adequatelyrecorded 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.), severeor 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-inflammatory drugs,anticoagulants,platelet aggregation inhibitors (except the use of aspirin for less 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: 524
Study Start date:
January 07, 2021
Estimated Completion Date:
December 20, 2021

Study Description

Detailed Description:

The study will include three phases: screening, treatment and follow-up. 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

    Xi'an, Shaanxi 710032
    China

    Site Not Available

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