Esomeprazole/Vonoprazan Combined With High-dose Amoxicillin Dual Therapy for Primary Eradication of Helicobacter Pylori Infection
- Conditions
- Helicobacter Pylori Infection
- Interventions
- Registration Number
- NCT06250634
- Brief Summary
This study intends to collect the clinical data of patients with Helicobacter pylori infection, and to observe and count the high-dose double therapy and the traditional quadruple / triple therapy ( i.e., esomeprazole + amoxicillin double high-dose double therapy and esomeprazole + amoxicillin + clarithromycin + colloidal bismuth tartrate traditional quadruple therapy or Vonoprazan + amoxicillin double high-dose double therapy and Vonoprazan + amoxicillin + clarithromycin triple therapy ). The eradication rate of Helicobacter pylori was compared between the two different regimens respectively, and the efficacy, safety and compliance of different regimens were compared. It provides a new reference for clinical treatment of Helicobacter pylori, and has great clinical value and significance for simplifying the anti-Helicobacter-pylori treatment plan, increasing patient compliance, and exploring efficient anti-Helicobacter-pylori therapy suitable for the Chinese population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 806
- patients aged 14-90 years, no requirement for gender;
- patients diagnosed as H. pylori infection by at least one of the following tests: carbon-13/14 urea breath test (13C/14C-UBT) or immuno-histochemical staining of biopsy specimens;
- patients with no use of antibiotics, bismuth or Chinese traditional medicines with antibacterial effects in the previous 4 weeks of 13C/14C-UBT, and no H2 receptor antagonists, PPIs, P-CAB or other drugs affecting H .pylori activity within the previous 2 weeks of 13C/14C-UBT;
- patients without history of receiving H. pylori eradication therapy.
- patients with serious diseases or clinical conditions that may interfere with the evaluation of the results of the study, such as severe heart, liver, lung, and renal insufficiency, low immunity, and so on;
- patients with allergy to penicillin or any research-program-related drugs;
- patients with mental illness and communication disorders;
- patients in pregnancy or lactation;
- patients with severe gastrointestinal diseases, such as gastrointestinal tumors, gastrointestinal bleeding, other organic diseases, etc.;
- patients who were participating in other clinical trials;
- patients who were considered inappropriate for enrollment after evaluation by the researchers.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Quadruple group ( Esomeprazole ) esomeprazole + amoxicillin + clarithromycin + colloidal bismuth tartrate agent - Triple group (Vonoprazan ) Vonoprazan + amoxicillin + clarithromycin - Double group ( Esomeprazole ) esomeprazole + amoxicillin - Double group ( Vonoprazan ) Vonoprazan + amoxicillin -
- Primary Outcome Measures
Name Time Method Helicobacter pylori eradication rate pre-intervention and at least 30 days post-intervention carbon-13/14 urea breath test
- Secondary Outcome Measures
Name Time Method Adverse events the 3rd, 7th, and 14th day during the intervention Compliance the 14th day during the intervention
Trial Locations
- Locations (1)
outpatient department of gastroenterology of the Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China