drugset / Trial / NCT06591494

The Efficacy of Quadruple Therapy Containing Sodium Bicarbonate as the Primary Treatment for Helicobacter Pylori Infection

NCT06591494

RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to learn the efficacy of sodium bicarbonate-containing quadruple therapy as the primary treatment for Helicobacter pylori infection. The main questions it aims to answer are: Can sodium bicarbonate replace bismuth or clarithromycin in the classic quadruple therapy for the primary treatment of Helicobacter pylori infection? What is the safety and cost-effectiveness of sodium bicarbonate replacing bismuth or clarithromycin in the classic quadruple therapy for the primary treatment of Helicobacter pylori infection? Researchers will compare sodium bicarbonate replacing bismuth or clarithromycin in the classic quadruple therapy to see the efficacy of sodium bicarbonate as an alternative to bismuth or clarithromycin in the classic quadruple therapy for the primary treatment of Helicobacter pylori infection. Participants will: Take Helicobacter pylori treatment drugs for 14 days Recheck 13C-UBT or 14C-UBT breath test 6-8 weeks after eradication treatment Incidence of adverse reactions (AEs) and patient compliance

Timeline

Start
2024-09-15
Primary completion
2025-09-30
Completion
2025-12-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bismuth pectin Unknown 200 mg
Comparator Clarithromycin Small molecule 500 mg
Subject sodium bicarbonate Diagnostic / imaging agent 500 mg
Comparator Amoxicillin Other / unclassified 1 g
Comparator Esomeprazole Small molecule 20 mg