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

Phase 2

Not yet recruiting

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Classic quadruple therapy; Drug: Quadruple therapy with sodium bicarbonate instead of bismuth; Drug: Quadruple therapy with sodium bicarbonate instead of clarithromycin

• Registration Number: NCT06591494
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-08
• Study First Submitted QC: 2024-09-08
• Last Update Submitted: 2024-09-08
• Study First Posted: 2024-09-11
• Last Update Posted: 2024-09-11
• Study Start: 2024-09-15
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 855

Inclusion Criteria

• Aged 18-65 years, no history of eradication therapy;
• Diagnosed with Helicobacter pylori infection by one or more of the following methods: gastric mucosal histochemical staining, tissue culture, 14C-UBT, 13C-UBT and/or fecal antigen;
• Patients with warning symptoms, family history of gastric cancer or over 40 years old should undergo endoscopic examination before eradication therapy;
• Voluntarily participate in clinical trials and sign informed consent.

Exclusion Criteria

• Use of antibiotics or bismuth within 4 weeks before enrollment, or use of acid suppressants (including H2RA, PPI or P-CAB) within 2 weeks;
• Active peptic ulcer with complications such as bleeding, perforation or obstruction;
• History of esophagectomy or gastrectomy;
• Allergy to any study drug;
• Pregnancy or lactation;
• History of alcoholism or drug abuse;
• Mental illness;
• Incapacity for civil conduct.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Classic quadruple therapy	Classic quadruple therapy	Esomeprazole 20 mg BID Bismuth pectin 200 mg BID Amoxicillin 1 g BID Clarithromycin 500 mg BID for 14 days
Quadruple therapy with sodium bicarbonate instead of bismuth	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 for 14 days
Quadruple therapy with sodium bicarbonate instead of clarithromycin	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 for 14 days

Primary Outcome Measures

Name	Time	Method
Helicobacter pylori eradication rate	6-8 weeks after eradication treatment	Repeat 13C-UBT or 14C-UBT breath test, negative results (\<4.0‰, delta over baseline, 13C-UBT DOB; \<100, DPM, 14C-UBT) indicate successful eradication. Patients are not allowed to take PPIs or P-CAB drugs 2 weeks before the breath test, and are not allowed to take antibiotics 4 weeks before the breath test.

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse reactions (AEs)	One month after finishing with therapy	Participants\' symptoms during treatment, such as nausea, vomiting, diarrhea, rash, belching, abdominal pain, bloating, or other aggravated symptoms, were recorded and divided into three categories based on their impact on daily life: mild (transient, well tolerated), moderate (some discomfort that interferes with daily life), and severe (severe discomfort that adversely affects daily life).
Compliance of patients	One month after finishing with therapy	Good compliance was defined as taking at least 80% of the medication.