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NOT YET RECRUITING
NCT06591494
PHASE2/PHASE3

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

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

855

Start Date

2024-09-15

Completion Date

2025-12-30

Last Updated

2024-09-19

Healthy Volunteers

No

Interventions

DRUG

Classic quadruple therapy

Esomeprazole 20 mg BID Bismuth pectin 200 mg BID Amoxicillin 1 g BID Clarithromycin 500 mg BID

DRUG

Quadruple therapy with sodium bicarbonate instead of bismuth

Esomeprazole 20 mg BID Sodium bicarbonate 500 mg TID Amoxicillin 1 g BID Clarithromycin 500 mg BID

DRUG

Quadruple therapy with sodium bicarbonate instead of clarithromycin

Esomeprazole 20 mg BID Bismuth pectin 200 mg BID Amoxicillin 1 g BID Sodium bicarbonate 500 mg TID