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

Zhejiang University

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Quadruple therapy with sodium bicarbonate instead of clarithromycin; Drug: Quadruple therapy with sodium bicarbonate instead of bismuth; Drug: Classic quadruple therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06591494

2024-0814

Details and patient eligibility

About

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

Enrollment: 855 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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855 participants in 3 patient groups

Classic quadruple therapy

Active Comparator group

Description:

Esomeprazole 20 mg BID Bismuth pectin 200 mg BID Amoxicillin 1 g BID Clarithromycin 500 mg BID for 14 days

Treatment:

Drug: Classic quadruple therapy

Quadruple therapy with sodium bicarbonate instead of bismuth

Experimental group

Description:

Esomeprazole 20 mg BID Sodium bicarbonate 500 mg TID Amoxicillin 1 g BID Clarithromycin 500 mg BID for 14 days

Treatment:

Drug: Quadruple therapy with sodium bicarbonate instead of bismuth

Quadruple therapy with sodium bicarbonate instead of clarithromycin

Experimental group

Description:

Esomeprazole 20 mg BID Bismuth pectin 200 mg BID Amoxicillin 1 g BID Sodium bicarbonate 500 mg TID for 14 days

Treatment:

Drug: Quadruple therapy with sodium bicarbonate instead of clarithromycin