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

NCT07720037 | Not Yet Recruiting Phase 4

• 1 other identifier: KYLL-2026-01-003-2
• Study Type: interventional
• Target: 232
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Helicobacter Infection; Vonoprazan; Amoxicillin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Rate of adverse reactions

  immediately after the procedure

• Patient compliance

  immediately after the procedure

Study Arms (2)

10-day group

EXPERIMENTAL

10-day dual therapy, vonoprazan (Takeda Pharmaceutical Company Limited) 20mg tid, amoxicillin (United Laboratories Co., LTD) 1000mg tid

Drug: 10-day group

14-day group

ACTIVE COMPARATOR

14-day dual therapy, vonoprazan (Takeda Pharmaceutical Company Limited) 20mg bid, amoxicillin (United Laboratories Co., LTD) 1000mg tid

Drug: 14-day group

Interventions

14-day group DRUG

vonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days

14-day group

10-day group DRUG

vonoprazan 20mg tid and amoxicillin 1000mg tid for 10 days

10-day group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shandong University: lead

MeSH Terms

Conditions

Helicobacter Infections

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Qilu Hospital gastroenterology department

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: July 22, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): May 30, 2028
• Last Updated: July 22, 2026

Record last verified: 2026-07