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Not yet recruitingNCT07352098Updated Jan 20, 2026

7-day High-Dose Vonoprazan-amoxicillin Dual Therapy Versus 14-day Vonoprazan-amoxicillin Dual Therapy for H. Pylori

An interventional study of 7-day high-dose vonoprazan-amoxicillin dual therapy group and 14-day vonoprazan-amoxicillin dual therapy group in Helicobacter, sponsored by Yueyue Li. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-01-20.

Sponsored by Yueyue Li · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
290
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study summary

Helicobacter pylori infection is a prevalent global gastrointestinal condition linked to chronic gastritis, peptic ulcer disease, and gastric cancer. Potent and sustained acid suppression improves eradication efficacy. Vonoprazan, a potassium-competitive acid blocker, provides rapid and stable acid inhibition and has become an important component of dual therapy with amoxicillin. However, the optimal dosing strategy and treatment duration for vonoprazan-based dual therapy are not yet fully established.

This multicenter, open-label, randomized controlled trial compares the efficacy and safety of a short-term, high-dose vonoprazan-based dual therapy (20 mg three times daily for 7 days) with a standard-dose regimen (20 mg twice daily for 14 days), both combined with amoxicillin, for first-line H. pylori eradication. Adult participants with confirmed H. pylori infection will be randomized 1:1 to the two treatment groups. The primary outcome is the eradication rate of H. pylori at 6 weeks after completion of therapy. Secondary outcomes include safety assessments and medication adherence. This study will provide evidence on whether a higher dose and shorter treatment course can achieve similar eradication rates with acceptable safety and tolerability compared to the standard regimen.

02

Conditions studied

  • Helicobacter

Keywords

  • dual therapy
  • short term
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In context

Lead sponsor

Yueyue Li is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age 18-70 years, no gender restrictions;
  • Patients with H. pylori infection confirmed by 13C/14C-urea breath test ;
  • No prior history of H. pylori eradication therapy;

Exclusion criteria

Exclusion Criteria:

  • Patients allergic to study medications (vonoprazan fumarate, amoxicillin);
  • Patients with active qastrointestinal bleeding,;
  • Patients undergone or scheduled to undergo surgery within 1 month prior to randomization or during the study period that may affect gastric acid secretion (e.g., gastric surgery, vagotomy, or craniotomy);
  • Patients underlying severe medical conditions deemed by the investigator to potentially confound study results or compromise subject safety, such as: hepatic impairment (ALT or AST > 1.5 times the upper limit of normal); renal impairment (Cr ≥ 2.0 mg/dL or eGFR \< 50 mL/min/1.73 m²); immunosuppression; malignancy; severe central nervous system, cardiovascular, or respiratory disease;
  • Patients with medication history of bismuth, antibiotics within 4 weeks, or proton pump inhibitors within 2 weeks;
  • Patients with behaviors potentially increasing disease risk: history of chronic substance abuse or alcohol dependence within 12 months prior to screening;
  • Patients planning pregnancy, currently pregnant, breastfeeding, or unwilling to use contraception during the trial period;
  • Patients unable or unwilling to provide informed consent.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
290 participants (estimated)

Study arms

  • Experimental
    7-day high-dose vonoprazan-amoxicillin dual therapy group

    Drug: 7-day high-dose vonoprazan-amoxicillin dual therapy group

  • Experimental
    14-day vonoprazan-amoxicillin dual therapy group

    Drug: 14-day vonoprazan-amoxicillin dual therapy group

Interventions

  • Drug7-day high-dose vonoprazan-amoxicillin dual therapy group

    Patients in the 7-day high-dose vonoprazan-amoxicillin dual therapy group received vonoprazan fumarate tablets 20 mg three times daily, administered 30 minutes before meals, and amoxicillin 1,000 mg three times daily, taken after meals. Both medications were administered orally for 7 consecutive days.

  • Drug14-day vonoprazan-amoxicillin dual therapy group

    Patients in the 14-day vonoprazan-amoxicillin dual therapy group received vonoprazan fumarate tablets 20 mg twice daily, administered 30 minutes before meals, and amoxicillin 1,000 mg three times daily, taken after meals. Both medications were administered orally for 14 consecutive days.

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What researchers measure

Primary outcomes

  1. Eradication rate

    Time frame: 6 weeks after treatment

Secondary outcomes

  1. incidence of adverse events

    Time frame: immediately after treatment

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Study locations

1 site
  • Kashi Prefecture Hospital of Traditional Chinese Medicine
    Kashgar, Xinjiang 844000, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07352098
Lead sponsor
Yueyue Li
Collaborators
Qilu Hospital of Shandong University, Shandong University of Traditional Chinese Medicine, Zaozhuang Municipal Hospital, Qilu Hospital of Shandong University, Dezhou Branch, Yantai Zhifu Hospital, Kashi Prefecture Hospital of Traditional Chinese Medicine, Guanxian County People's Hospital
Responsible party
Yueyue Li (associate chief physician, Qilu Hospital of Shandong University) — Sponsor-investigator
First posted
Jan 20, 2026
Start date
Feb 1, 2026 (estimated)
Primary completion
Feb 1, 2028 (estimated)
Completion
Feb 1, 2028 (estimated)
Last update
Jan 20, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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