Efficacy Comparison of 10-Day High-Dose Versus 14-Day Standard-Dose Vonoprazan Plus Amoxicillin in Helicobacter Pylori Eradication: A Multicenter Non-Inferiority Randomized Controlled Trial

Comparison of Eradication Efficacy Between 10-Day High-Dose Vonoprazan and 14-Day Standard-Dose Vonoprazan Combined With Amoxicillin for Helicobacter Pylori: A Multicenter, Non-Inferiority Randomized Controlled Trial

This is a multicenter non-inferiority randomized controlled trial for patients infected with Helicobacter pylori. Eligible participants will be randomly split into two groups. One group will take high-dose vonoprazan combined with amoxicillin (vonoprazan 20mg tid, amoxicillin 1000mg bid) for 10 days, while the other group will receive standard-dose vonoprazan plus amoxicillin (vonoprazan 20mg bid, amoxicillin 1000mg bid) for 14 days. The main goal of this study is to compare how well the two treatment plans clear the H. pylori bacteria. We aim to check if the 10-day high-dose treatment works no worse than the 14-day standard treatment. Every participant will take a follow-up test after treatment to see if the bacteria have been eliminated.

Study Overview

• Status: Not yet recruiting
• Conditions: Vonoprazan; Amoxicillin; Helicobacter Infection
• Intervention / Treatment: Drug: 10-day group; Drug: 14-day group

• Study Type: Interventional
• Enrollment (Estimated): 232
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged 18 to 70 years, no restriction on gender
2. Current Helicobacter pylori infection (positive result of either ¹³C or ¹⁴C urea breath test)
3. No prior history of Helicobacter pylori eradication therapy

Exclusion Criteria:

1. Severe underlying diseases, including hepatic insufficiency, renal insufficiency, malignant tumors, etc.
2. Active gastrointestinal bleeding
3. History of upper gastrointestinal surgery
4. History of allergy to study medications
5. Use of bismuth agents or antibiotics within 4 weeks prior to enrollment; use of acid-suppressive agents within 2 weeks prior to enrollment
6. Pregnant or breastfeeding women, and subjects who refuse to take contraceptive measures during the trial
7. Behaviors that may increase disease risks, such as chronic alcohol abuse and drug addiction
8. Subjects who are unable or unwilling to sign the informed consent form

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 10-day group; 10-day dual therapy, vonoprazan (Takeda Pharmaceutical Company Limited) 20mg tid, amoxicillin (United Laboratories Co., LTD) 1000mg tid	Drug: 10-day group; vonoprazan 20mg tid and amoxicillin 1000mg tid for 10 days
Active Comparator: 14-day group; 14-day dual therapy, vonoprazan (Takeda Pharmaceutical Company Limited) 20mg bid, amoxicillin (United Laboratories Co., LTD) 1000mg tid	Drug: 14-day group; vonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eradication rates	Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori in two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medicines. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.	immediately after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient compliance	Good compliance is defined as the actual dosage is within the range of 80%-100% of the dosage that should be taken.	immediately after the procedure
Rate of adverse reactions		immediately after the procedure

Collaborators and Investigators

• Sponsor: Shandong University

Study record dates

Study Major Dates

• Study Start (Estimated): July 30, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): May 30, 2028

Study Registration Dates

• First Submitted: July 18, 2026
• First Submitted That Met QC Criteria: July 18, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 18, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Helicobacter Infections; Population Characteristics; Demography; Population Groups
• Other Study ID Numbers: KYLL-2026-01-003-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No