HelicobacterNCT07352098
7-day High-Dose Vonoprazan-amoxicillin Dual Therapy Versus 14-day Vonoprazan-amoxicillin Dual Therapy for H. Pylori
A study testing 7-day high-dose vonoprazan-amoxicillin dual therapy group and 14-day vonoprazan-amoxicillin dual therapy group in people with Helicobacter, run by Yueyue Li at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Helicobacter
- What is being tested?
- 7-day high-dose vonoprazan-amoxicillin dual therapy group and 14-day vonoprazan-amoxicillin dual therapy group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Kashi Prefecture Hospital of Traditional Chinese Medicine
Kashgar, Xinjiang, 844000
Yueyue Li, +86 18560089751, lyynqj@126.com
About this study
Official title: Efficacy and Safety of Short-Term, High-Dose Vonoprazan-Based Dual Therapy Versus Standard-Dose Vonoprazan-Based Dual Therapy for Helicobacter Pylori Eradication: A Multicenter, Open-Label, Randomized Controlled Trial
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.
- Conditions
- Helicobacter
- Being tested
- 7-day high-dose vonoprazan-amoxicillin dual therapy group, 14-day vonoprazan-amoxicillin dual therapy group
- Keywords
- dual therapy, short term
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7-day high-dose vonoprazan-amoxicillin dual therapy groupDrug
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.
14-day vonoprazan-amoxicillin dual therapy groupDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 7-day high-dose vonoprazan-amoxicillin dual therapy group | Experimental | Not described Receives: Drug: 7-day high-dose vonoprazan-amoxicillin dual therapy group |
| 14-day vonoprazan-amoxicillin dual therapy group | Experimental | Not described Receives: Drug: 14-day vonoprazan-amoxicillin dual therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate
Measured: 6 weeks after treatment
Secondary outcomes (1)
incidence of adverse events
Measured: immediately after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HelicobacterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants with Helicobacter pylori infection will be randomly assigned in a 1:1 ratio to one of two treatment groups: * A 7-day high-dose vonoprazan-amoxicillin dual therapy group: vonoprazan 20 mg three times daily + amoxicillin 1,000 mg three times daily, administered orally for 7 days. * A 14-day vonoprazan-amoxicillin dual therapy group: vonoprazan 20 mg twice daily + amoxicillin 1,000 mg three times daily, administered orally for 14 days.
- Masking
- None (open label)
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yueyue Li
- Sponsor type
- University, hospital or other
- 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
- Sponsor-investigator, Yueyue Li, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352098
- Sponsor's protocol ID
- 202510
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Short-Term, High-Dose Vonoprazan-Based Dual Therapy Versus Standard-Dose Vonoprazan-Based Dual Therapy for Helicobacter Pylori Eradication: A Multicenter, Open-Label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07352098
- Acronym / sponsor ID
- 202510
- Conditions
- Helicobacter
- Keywords
- dual therapy, short term
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Yueyue LiUniversity, hospital or other
- 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
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants with Helicobacter pylori infection will be randomly assigned in a 1:1 ratio to one of two treatment groups: * A 7-day high-dose vonoprazan-amoxicillin dual therapy group: vonoprazan 20 mg three times daily + amoxicillin 1,000 mg three times daily, administered orally for 7 days. * A 14-day vonoprazan-amoxicillin dual therapy group: vonoprazan 20 mg twice daily + amoxicillin 1,000 mg three times daily, administered orally for 14 days.
| Arm | Type | Receives |
|---|---|---|
| 7-day high-dose vonoprazan-amoxicillin dual therapy group | Experimental | Drug: 7-day high-dose vonoprazan-amoxicillin dual therapy group |
| 14-day vonoprazan-amoxicillin dual therapy group | Experimental | Drug: 14-day vonoprazan-amoxicillin dual therapy group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7-day high-dose vonoprazan-amoxicillin dual therapy groupPatients 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. | Drug | 7-day high-dose vonoprazan-amoxicillin dual therapy group |
| 14-day vonoprazan-amoxicillin dual therapy groupPatients 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. | Drug | 14-day vonoprazan-amoxicillin dual therapy group |
Primary outcome
Eradication rate
Time frame: 6 weeks after treatment
1 secondary outcome
incidence of adverse events
Time frame: immediately after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kashi Prefecture Hospital of Traditional Chinese Medicine
Kashgar, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 7-day high-dose vonoprazan-amoxicillin dual therapy group and 14-day vonoprazan-amoxicillin dual therapy group in people with Helicobacter, run by Yueyue Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication rate (time frame: 6 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.