The Evaluation of Triple Therapy With Vonoprazan, Amoxicillin and Bismuth for Eradication of Helicobacter Pylori

Huazhong University of Science and Technology

Status: Unknown

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Esomeprazole; Drug: Clarithromycin; Drug: Bismuth potassium citrate; Drug: Vonoprazan; Drug: Amoxicillin

Study type: Interventional

Funder types: Other

Identifiers

NCT05189444

Vonoprazan-Hp-2021

Details and patient eligibility

About

The eradication rate of standard quadruple therapy has become less successful due to low compliance and high resistance to antibiotics. Therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. The aim of this prospective study is to investigate the efficacy of Triple Therapy with Vonoprazan, Amoxicillin, and Bismuth for eradication of Hp, compared with standard quadruple therapy.

Full description

In China, the first-line therapy to treat Helicobacter pylori (Hp) consists of a bismuth-based proton pump inhibitor (PPI) and two antibiotics for 14 days.But, eradication has become less successful due to low compliance and high resistance to antibiotics. Therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. Vonoprazan is a novel potassium-competitive acid blocker more effective in suppressing acid production than proton pump inhibitors (PPIs). Several studies previously suggested that vonoprazan containing antibiotic therapy was superior to other PPI-containing therapies for Hp. Most strains of Helicobacter pylori are sensitive to amoxicillin. Bismuth salts, a topical agent, which are available in our country, have a synergistic effect on antibiotics and decrease the bacterial load. Therefore, the investigators performed a prospective, multi-center, randomized trial, to investigate the efficacy of Triple Therapy with Vonoprazan, Amoxicillin, and Bismuth for eradication of Hp, compared with standard quadruple therapy.

Enrollment: 672 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Helicobacter pylori infected patients comfirmed by 13C/14C UBT
• age 18~65

Exclusion criteria

• prior Hp eradication therapy including amoxicillin and clarithromycin
• previous gastric resection
• allergic to the drugs used in this study
• previous use of proton pump inhibitors, bismuth, H2 receptor antagonist or antibiotics, probiotics within 4 weeks of the study
• Patients who were pregnant or lactating
• Patients taking NSAIDs, alcoholic or with other serious disease (e.g. hepatopathy, heart disease, nephropathy#diabete mellitus, hypertension...) effect the evaluation of this study
• Can't express the complaint correctly

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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672 participants in 2 patient groups

Vonoprazan group

Experimental group

Description:

Vonoprazan + Amoxicillin + Bismuth potassium citrate Drug: Vonoprazan 20mg bid Other Names: no Drug: Amoxicillin 0.75g tid Other Names: no Drug: Bismuth potassium citrate 0.22g bid Other Names: no

Treatment:

Drug: Amoxicillin

Drug: Vonoprazan

Drug: Amoxicillin

Drug: Bismuth potassium citrate

control group: quadruple therapy

Active Comparator group

Description:

Drug: Esomeprazole 20mg bid Other Names: no Drug: Amoxicillin 1.0g bid Other Names: no Drug: Clarithromycin 0.5g bid Other Names:no Drug: Bismuth potassium citrate 0.22g bid Other Names:no

Treatment:

Drug: Clarithromycin

Drug: Esomeprazole

Drug: Amoxicillin

Drug: Amoxicillin

Drug: Bismuth potassium citrate