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

Sponsor

Huazhong University of Science and Technology (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05189444

Collaborator

(none)

672

Enrollment

Location

Arms

9.2

Anticipated Duration (Months)

72.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Drug: Vonoprazan Drug: Amoxicillin Drug: Esomeprazole Drug: Amoxicillin Drug: Clarithromycin Drug: Bismuth potassium citrate	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

672 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Evaluation of Triple Therapy With Vonoprazan, Amoxicillin and Bismuth for Eradication of Helicobacter Pylori: a Prospective, Multi-Center, Randomized Controlled Trial

Anticipated Study Start Date :

Mar 25, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vonoprazan group 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	Drug: Vonoprazan 20mg bid Drug: Amoxicillin 0.75g tid Drug: Bismuth potassium citrate 0.22g bid
Active Comparator: control group: quadruple therapy 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	Drug: Esomeprazole 20mg bid Drug: Amoxicillin 1.0g bid Drug: Clarithromycin 0.5g bid Drug: Bismuth potassium citrate 0.22g bid

Arm

Intervention/Treatment

Experimental: Vonoprazan group

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

Drug: Vonoprazan

20mg bid

Drug: Amoxicillin

0.75g tid

Drug: Bismuth potassium citrate

0.22g bid

Active Comparator: control group: quadruple therapy

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

Drug: Esomeprazole

20mg bid

Drug: Amoxicillin

1.0g bid

Drug: Clarithromycin

0.5g bid

Drug: Bismuth potassium citrate

0.22g bid

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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
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