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

March 20, 2022 updated by: Bin Cheng, Huazhong University of Science and Technology

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

672

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital, Tongji Medical College, HUST

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: Amoxicillin
1.0g bid
Drug: Bismuth potassium citrate
0.22g bid
Drug: Vonoprazan
20mg bid
Drug: Amoxicillin
0.75g tid
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
Drug: Amoxicillin
0.75g tid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Helicobacter pylori eradication
Time Frame: 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.
6 weeks after treatment initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: 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.
2 weeks and 6 weeks after treatment initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huazhong University of Science and Technology

Investigators

  • Study Chair: si xiong, Doctor, Tongji Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 25, 2022

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

December 29, 2021

First Submitted That Met QC Criteria

December 29, 2021

First Posted (Actual)

January 12, 2022

Study Record Updates

Last Update Posted (Actual)

March 22, 2022

Last Update Submitted That Met QC Criteria

March 20, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vonoprazan-Hp-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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