Study on the Efficacy and Safety of Berberine, Minocycline, Esomeprazole, and Colloidal Bismuth Quadruple Therapy in the Initial Treatment of Helicobacter Pylori.
NCT ID: NCT06603688
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
548 participants
INTERVENTIONAL
2023-11-20
2024-12-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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experimental group：Minocycline+Berberine quadruple therapy
40mg of esomeprazole, 220mg of colloidal bismuth tartrate, 500mg of berberine hydrochloride, and 100mg of minocycline, taken orally twice daily for 14 days.
esomeprazole
Esomeprazole 40mg, twice daily for 14 days.
Bismuth
Bismuth 220mg, twice daily for 14 days.
Berberine
Berberine 500 mg, twice daily for 14 days
Minocycline
Minocycline 100 mg, twice daily for 14 days
control group：Amoxicillin+clarithromycin quadruple
40mg of esomeprazole, 220mg of bismuth tartrate colloid, 500mg of clarithromycin, and 1000mg of amoxicillin, taken orally twice a day for 14 days.
esomeprazole
Esomeprazole 40mg, twice daily for 14 days.
Bismuth
Bismuth 220mg, twice daily for 14 days.
Amoxicillin
Amoxicillin 1000mg, twice daily for 14 days.
clarithromycin
clarithromycin 500mg, twice daily for 14 days.
Interventions
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esomeprazole
Esomeprazole 40mg, twice daily for 14 days.
Bismuth
Bismuth 220mg, twice daily for 14 days.
Amoxicillin
Amoxicillin 1000mg, twice daily for 14 days.
clarithromycin
clarithromycin 500mg, twice daily for 14 days.
Berberine
Berberine 500 mg, twice daily for 14 days
Minocycline
Minocycline 100 mg, twice daily for 14 days
Eligibility Criteria
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Inclusion Criteria
2. Patients with upper gastrointestinal symptoms and with documented H.pylori infection who 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 contraceptive methods during and 30 days after the trial.
Exclusion Criteria
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 intraepithelial neoplasia.
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.
18 Years
70 Years
ALL
Yes
Sponsors
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Xijing Hospital of Digestive Diseases
OTHER
Responsible Party
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Yongquan Shi
professor
Locations
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Xijing Hosipital of Digestive Disease
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KY20232384-C-1
Identifier Type: -
Identifier Source: org_study_id
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