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

StatusUnknown
PhasePhase 2/3
Started
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Record status
This record was last updated September 19, 2024 (before its estimated September 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Not Yet Recruiting
  2. Notable Changed Sponsor changed: Second Affiliated Hospital, School of Medicine, Zhejiang University to Second Affiliated Hospital, Zhejiang University, School of Medicine
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06591494
Lead Sponsor Second Affiliated Hospital, Zhejiang University, School of Medicine
Conditions
(from sponsor)
Helicobacter Pylori Infection
Enrollment 855 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov