Esomeprazole/Vonoprazan Combined With High-dose Amoxicillin Dual Therapy for Primary Eradication of Helicobacter Pylori Infection

Central South University

Status: Completed

Conditions: Helicobacter Pylori Infection

Treatments: Drug: esomeprazole + amoxicillin + clarithromycin + colloidal bismuth tartrate agent; Drug: Vonoprazan + amoxicillin; Drug: esomeprazole + amoxicillin; Drug: Vonoprazan + amoxicillin + clarithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT06250634

Fast 21292, Fast 23359

Details and patient eligibility

About

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.

Enrollment: 806 patients

Sex: All

Ages: 14 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. patients aged 14-90 years, no requirement for gender;
2. 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;
3. 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;
4. patients without history of receiving H. pylori eradication therapy.

Exclusion criteria

1. 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;
2. patients with allergy to penicillin or any research-program-related drugs;
3. patients with mental illness and communication disorders;
4. patients in pregnancy or lactation;
5. patients with severe gastrointestinal diseases, such as gastrointestinal tumors, gastrointestinal bleeding, other organic diseases, etc.;
6. patients who were participating in other clinical trials;
7. patients who were considered inappropriate for enrollment after evaluation by the researchers.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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806 participants in 4 patient groups

Double group ( Esomeprazole )

Experimental group

Treatment:

Drug: esomeprazole + amoxicillin

Quadruple group ( Esomeprazole )

Active Comparator group

Treatment:

Drug: esomeprazole + amoxicillin + clarithromycin + colloidal bismuth tartrate agent

Double group ( Vonoprazan )

Experimental group

Treatment:

Drug: Vonoprazan + amoxicillin

Triple group (Vonoprazan )

Active Comparator group

Treatment:

Drug: Vonoprazan + amoxicillin + clarithromycin