drugset / Trial / NCT06603688

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

NCT06603688

Phase 4 Unknown 548 enrolled Xijing Hospital of Digestive Diseases
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-11-20
Primary completion
2024-11-01
Completion
2024-12-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amoxicillin Other / unclassified 1000 mg Oral
Subject Berberine Traditional medicine (herbal / TCM) 500 mg Oral
Comparator Clarithromycin Small molecule 500 mg Oral
Subject Minocycline Small molecule 100 mg Oral
Background Bismuth Potassium Citrate Unknown 220 mg Oral
Background Esomeprazole Small molecule 40 mg Oral