VA Dual Sequential Therapy

Summary

Sequential therapy for Hp was first introduced by Zullo et al. in 2000 and consists of two phases: the first phase involves proton pump inhibitors with one antibiotic, and the second phase involves proton pump inhibitors with two antibiotics. Based on this, the investigators propose a modified sequential therapy, where the first phase uses vonoprazan combined with amoxicillin, and the second phase increases the amoxicillin dosage, forming a high-dose amoxicillin regimen. This new treatment strategy combines the staged nature of sequential therapy with the advantages of high-dose dual therapy, gradually increasing the drug dosage to help patients adapt and reduce side effects (such as nausea, vomiting, and diarrhea), thereby improving patient tolerance.

The primary aim of this study is to compare the vonoprazan combined with high-dose amoxicillin sequential therapy with standard dual therapy (14-day regimen) in terms of Hp eradication rates, efficacy, side effect incidence, and patient compliance, to evaluate its improved effectiveness. Additionally, the study will explore the impact of a shortened treatment duration on the modified dual sequential therapy's efficacy for Hp infection.

Eligible participants in this study will be randomly assigned to one of the following three treatment groups based on a pre-generated randomization sequence:

Control Group: Vonoprazan combined with high-dose amoxicillin dual therapy for 14 days (VADT-14): Vonoprazan 20mg twice daily + Amoxicillin 1g three times daily.

Experimental Group 1: Vonoprazan combined with amoxicillin dual sequential therapy for 14 days (VAST-14):

Days 1 to 7: Vonoprazan 20mg twice daily + Amoxicillin 1g twice daily. Days 8 to 14: Vonoprazan 20mg twice daily + Amoxicillin 1g three times daily.

Experimental Group 2: Vonoprazan combined with amoxicillin dual sequential therapy for 10 days (VAST-10):

Days 1 to 5: Vonoprazan 20mg twice daily + Amoxicillin 1g twice daily. Days 6 to 10: Vonoprazan 20mg twice daily + Amoxicillin 1g three times daily.

Conditions

• Helicobacter Pylori Infection

Interventions

DRUG

Vonoprazan and Amoxicillin for the first 7 days

20mg Vonoprazan twice times daily and 1g Amoxicillin twice times daily for 7 days

DRUG

Vonoprazan and Amoxicillin for the first 5 days

20mg Vonoprazan twice times daily and 1g Amoxicillin twice times daily for 5 days

DRUG

Vonoprazan and Amoxicillin for the second 7 days

20mg Vonoprazan twice times daily and 1g Amoxicillin three times daily for 7 days

DRUG

Vonoprazan and Amoxicillin for the second 5 days

20mg Vonoprazan twice times daily and 1g Amoxicillin three times daily for 5 days

DRUG

Vonoprazan and Amoxicillin for 14 days

20mg Vonoprazan twice times daily and 1g Amoxicillin three times daily for 14 days

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-24

Primary Completion

2026-12-01

Completion

2026-12-31

Countries

• China

Study Locations