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

Not Applicable

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Vonoprazan; Drug: Esomeprazole; Drug: Amoxicillin; Drug: Bismuth potassium citrate; Drug: Clarithromycin

• Registration Number: NCT05189444
• Lead Sponsor: Huazhong University of Science and Technology

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-12-29
• Study First Submitted QC: 2021-12-29
• Study First Posted: 2022-01-12
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-20
• Last Update Posted: 2022-03-22
• Study Start: 2022-03-25
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 672

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vonoprazan group	Bismuth potassium citrate	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
control group: quadruple therapy	Amoxicillin	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
Vonoprazan group	Amoxicillin	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
control group: quadruple therapy	Bismuth potassium citrate	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
Vonoprazan group	Vonoprazan	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
control group: quadruple therapy	Esomeprazole	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
control group: quadruple therapy	Clarithromycin	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

Primary Outcome Measures

Name	Time	Method
Helicobacter pylori eradication	6 weeks after treatment initiation	to investigate the efficacy of Triple Therapy with Vonoprazan, Amoxicillin and Bismuth for eradication of Hp, compared with standard quadruple therapy.

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	2 weeks and 6 weeks after treatment initiation	to investigate the incidence of adverse events of Triple Therapy with Vonoprazan, Amoxicillin and Bismuth, compared with standard quadruple therapy.

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College, HUST; 🇨🇳 Wuhan, Hubei, China