Helicobacter PyloriPhase 4JSHERO4NCT07232095
7-Day Vonoprazan, High-Dose Amoxicillin, and Bismuth Therapy
A Phase 4 study testing VAB-7 and VA-14 in people with Helicobacter Pylori, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The 2024 American College of Gastroenterology (ACG) Clinical Guideline recommends a 14-day vonoprazan-amoxicillin (VA) regimen, consisting of vonoprazan 20 mg twice daily with amoxicillin 1000 mg three times daily, as a first-line treatment for Helicobacter pylori (H. pylori) infection. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Helicobacter Pylori
- What is being tested?
- VAB-7 and VA-14
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2026to 30 Jun 2027
- Phase
- Phase 4
- 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
- Aged 18 to 70 years, regardless of sex.
- Helicobacter pylori infection confirmed by ¹³C or ¹⁴C urea breath test within 1 month before enrollment.
- Chronic gastritis with H. pylori infection confirmed by endoscopy within 3 months, meeting the indications for eradication therapy in the Sixth National Consensus Report on the Management of Helicobacter pylori Infection (China), and willing to receive eradication treatment.
- No prior H. pylori eradication therapy.
- Written informed consent before participation.
Who cannot join
- Known allergy or hypersensitivity to any study medication (vonoprazan, amoxicillin, or bismuth).
- Use of potassium-competitive acid blockers (P-CABs), proton pump inhibitors (PPIs), H₂ receptor antagonists, antibiotics, bismuth preparations, or probiotics within 4 weeks before enrollment.
- Pregnant or lactating women.
- Concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or anticoagulants during the study period.
- Presence of serious comorbid conditions that may interfere with study evaluation, including significant cardiac, pulmonary, hepatic, renal, metabolic, or psychiatric disorders, or malignancy.
- History of gastric or esophageal surgery.
- Any condition or factor that may affect compliance or make it difficult for the subject to complete follow-up as required.
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, 1 recruiting
- Recruiting
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029
Feng Ye, PhD, 86+13815897873, fengye@njmu.edu.cn
About this study
Official title: 7-Day Vonoprazan-High-Dose Amoxicillin-Bismuth Therapy for First-Line Eradication of Helicobacter Pylori: A Multicenter Randomized Controlled Trial
The 2024 American College of Gastroenterology (ACG) Clinical Guideline recommends a 14-day vonoprazan-amoxicillin (VA) regimen, consisting of vonoprazan 20 mg twice daily with amoxicillin 1000 mg three times daily, as a first-line treatment for Helicobacter pylori (H. pylori) infection.
Our previous study on regimen optimization showed that vonoprazan 20 mg twice daily combined with amoxicillin 1 g three times daily or 750 mg four times daily for 10 days achieved satisfactory eradication rates exceeding 90%, with no significant difference between dosing frequencies. However, when the treatment duration was shortened to 7 days, both dosing schedules failed to reach satisfactory eradication rates, indicating a need for further optimization.
Read more
Bismuth has antibacterial and synergistic properties, such as disrupting bacterial membranes, suppressing protein synthesis, and reducing virulence factor expression. It may enhance the efficacy of antibiotics. Therefore, this study evaluated the efficacy and safety of a 7-day vonoprazan-high-dose amoxicillin-bismuth (VAB-7) regimen as a first-line treatment for H. pylori infection.
Eligible participants in this study will be randomly assigned to one of the following treatment groups based on a pre-generated randomization sequence:
Control Group: Vonoprazan combined with high-dose amoxicillin dual therapy for 14 days (VA-14): Vonoprazan 20mg twice daily + Amoxicillin 1g three times daily.
Experimental Group: Vonoprazan combined with high-dose amoxicillin and bismuth therapy for 7 days (VAB-7): Vonoprazan 20mg twice daily + Amoxicillin 1g three times daily+Bismuth 220mg twice daily.
Read the detailed description
Helicobacter pylori (H. pylori) is a Gram-negative bacterium that chronically colonizes the gastric mucosa, leading to persistent inflammation and mucosal injury. Eradication of H. pylori can prevent the recurrence of peptic ulcers, treat gastric mucosa-associated lymphoid tissue (MALT) lymphoma, and reduce the risk of gastric cancer. However, with the increasing prevalence of antibiotic resistance, eradication rates have gradually declined worldwide, creating an urgent need for more effective, safe, and practical treatment regimens.
In recent years, vonoprazan, a novel and potent potassium-competitive acid blocker (P-CAB), has emerged as an alternative to conventional proton pump inhibitors (PPIs). Its rapid onset and strong acid suppression provide an ideal environment for amoxicillin to maintain stable bactericidal activity. The vonoprazan-amoxicillin (VA) dual therapy has demonstrated excellent eradication efficacy and safety in several clinical studies and has been recommended by the 2024 American College of Gastroenterology (ACG) Clinical Guideline as a first-line treatment for H. pylori infection.
Our previous multicenter trial on regimen optimization showed that vonoprazan 20 mg twice daily combined with amoxicillin 1 g three times daily or 750 mg four times daily for 10 days achieved satisfactory eradication rates above 90%, with no significant difference between dosing frequencies. However, shortening the treatment duration to 7 days resulted in slightly lower eradication rates (below 90%), indicating that the shortened regimen may require further optimization to maintain high efficacy.
Bismuth compounds exhibit multiple antimicrobial and synergistic effects. They can inhibit H. pylori adhesion to the gastric mucosa, disrupt bacterial membrane integrity, suppress protein synthesis, and reduce the expression of virulence factors. In addition, bismuth enhances the activity of antibiotics such as amoxicillin by reducing bacterial resistance and increasing local drug concentration in the gastric mucosa. Previous studies have shown that 7-day bismuth-containing regimens(with amoxicillin and tetracycline) can achieve comparable eradication rates to 14-day regimens.
This study was designed to evaluate whether the addition of bismuth could improve the efficacy of a short-course vonoprazan-amoxicillin regimen. Specifically, the trial investigates the 7-day vonoprazan-high-dose amoxicillin-bismuth (VAB-7) regimen as a first-line treatment for H. pylori infection.
This multicenter, randomized, controlled trial aims to compare the efficacy and safety of VAB-7 with the standard 14-day vonoprazan-high-dose amoxicillin dual therapy (VA-14). The primary endpoint is the eradication rate of H. pylori confirmed by a ¹³C-urea breath test performed at least 4 weeks after treatment completion. Secondary outcomes include adverse event rates, patient adherence, and cost-effectiveness.
- Conditions
- Helicobacter Pylori
- Being tested
- VAB-7, VA-14
- Keywords
- Helicobacter Pylori, Vonoprazan, Amoxicillin, Bismuth, Eradication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAB-7Drug
Vonoprazan 20mg twice daily+Amoxicillin 1g three times daily+Bismuth 220mg twice daily for 7 days
VA-14Drug
Vonoprazan 20mg twice daily and Amoxicillin 1g three times daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| 7-day Vonoprazan-High-dose Amoxicillin-Bismuth therapy | Experimental | Vonoprazan 20mg twice daily+Amoxicillin 1g three times daily+Bismuth 220mg twice daily for 7 days Receives: Drug: VAB-7 |
| 14-day Vonoprazan-Amoxicillin dual therapy | Active comparator | Vonoprazan 20mg twice daily and Amoxicillin 1g three times daily for 14 days Receives: Drug: VA-14 |
What is being measured
The primary outcome is the main question the study is designed to answer.
H. pylori eradication rate
Rate of H. pylori successfully eradicated; The confirmation of H. pylori status was evaluated by Urea breath test.
Measured: 4-6 weeks after treatment completion
Secondary outcomes (3)
Patient compliance
Good compliance was defined as achieving ≥80% of drugs in the regimes and bad compliance was defined as achieving <80% of drugs.
Measured: 1 day after treatment completion
Adverse events
Adverse drug reactions, including the incidence of both overall and serious adverse events, will be assessed using a standardized questionnaire.
Measured: For the 7-day intervention: assessment on Day 3 and Day 7; For the 14-day intervention: assessment on Day 7 and Day 14.
Cost-effectiveness ratio
The cost-effectiveness ratio is defined as the total cost per patient for one course of H. pylori eradication treatment divided by the H. pylori eradication rate.
Measured: 1 day after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start8 Jan 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter PyloriStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Ye, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232095
- Sponsor's protocol ID
- 2025JSHERO4
- Acronym
- JSHERO4
- Status last verified
- Apr 2026
- First submitted
- 14 Nov 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 7-Day Vonoprazan-High-Dose Amoxicillin-Bismuth Therapy for First-Line Eradication of Helicobacter Pylori: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07232095
- Acronym / sponsor ID
- JSHERO4 / 2025JSHERO4
- Conditions
- Helicobacter Pylori
- Keywords
- Helicobacter Pylori, Vonoprazan, Amoxicillin, Bismuth, Eradication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 8 Jan 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 18 Nov 2025 (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.
The 2024 American College of Gastroenterology (ACG) Clinical Guideline recommends a 14-day vonoprazan-amoxicillin (VA) regimen, consisting of vonoprazan 20 mg twice daily with amoxicillin 1000 mg three times daily, as a first-line treatment for Helicobacter pylori (H. pylori) infection.
Our previous study on regimen optimization showed that vonoprazan 20 mg twice daily combined with amoxicillin 1 g three times daily or 750 mg four times daily for 10 days achieved satisfactory eradication rates exceeding 90%, with no significant difference between dosing frequencies. However, when the treatment duration was shortened to 7 days, both dosing schedules failed to reach satisfactory eradication rates, indicating a need for further optimization.
Bismuth has antibacterial and synergistic properties, such as disrupting bacterial membranes, suppressing protein synthesis, and reducing virulence factor expression. It may enhance the efficacy of antibiotics. Therefore, this study evaluated the efficacy and safety of a 7-day vonoprazan-high-dose amoxicillin-bismuth (VAB-7) regimen as a first-line treatment for H. pylori infection.
Eligible participants in this study will be randomly assigned to one of the following treatment groups based on a pre-generated randomization sequence:
Control Group: Vonoprazan combined with high-dose amoxicillin dual therapy for 14 days (VA-14): Vonoprazan 20mg twice daily + Amoxicillin 1g three times daily.
Experimental Group: Vonoprazan combined with high-dose amoxicillin and bismuth therapy for 7 days (VAB-7): Vonoprazan 20mg twice daily + Amoxicillin 1g three times daily+Bismuth 220mg twice daily.
Detailed description
Helicobacter pylori (H. pylori) is a Gram-negative bacterium that chronically colonizes the gastric mucosa, leading to persistent inflammation and mucosal injury. Eradication of H. pylori can prevent the recurrence of peptic ulcers, treat gastric mucosa-associated lymphoid tissue (MALT) lymphoma, and reduce the risk of gastric cancer. However, with the increasing prevalence of antibiotic resistance, eradication rates have gradually declined worldwide, creating an urgent need for more effective, safe, and practical treatment regimens.
In recent years, vonoprazan, a novel and potent potassium-competitive acid blocker (P-CAB), has emerged as an alternative to conventional proton pump inhibitors (PPIs). Its rapid onset and strong acid suppression provide an ideal environment for amoxicillin to maintain stable bactericidal activity. The vonoprazan-amoxicillin (VA) dual therapy has demonstrated excellent eradication efficacy and safety in several clinical studies and has been recommended by the 2024 American College of Gastroenterology (ACG) Clinical Guideline as a first-line treatment for H. pylori infection.
Our previous multicenter trial on regimen optimization showed that vonoprazan 20 mg twice daily combined with amoxicillin 1 g three times daily or 750 mg four times daily for 10 days achieved satisfactory eradication rates above 90%, with no significant difference between dosing frequencies. However, shortening the treatment duration to 7 days resulted in slightly lower eradication rates (below 90%), indicating that the shortened regimen may require further optimization to maintain high efficacy.
Bismuth compounds exhibit multiple antimicrobial and synergistic effects. They can inhibit H. pylori adhesion to the gastric mucosa, disrupt bacterial membrane integrity, suppress protein synthesis, and reduce the expression of virulence factors. In addition, bismuth enhances the activity of antibiotics such as amoxicillin by reducing bacterial resistance and increasing local drug concentration in the gastric mucosa. Previous studies have shown that 7-day bismuth-containing regimens(with amoxicillin and tetracycline) can achieve comparable eradication rates to 14-day regimens.
This study was designed to evaluate whether the addition of bismuth could improve the efficacy of a short-course vonoprazan-amoxicillin regimen. Specifically, the trial investigates the 7-day vonoprazan-high-dose amoxicillin-bismuth (VAB-7) regimen as a first-line treatment for H. pylori infection.
This multicenter, randomized, controlled trial aims to compare the efficacy and safety of VAB-7 with the standard 14-day vonoprazan-high-dose amoxicillin dual therapy (VA-14). The primary endpoint is the eradication rate of H. pylori confirmed by a ¹³C-urea breath test performed at least 4 weeks after treatment completion. Secondary outcomes include adverse event rates, patient adherence, and cost-effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 7-day Vonoprazan-High-dose Amoxicillin-Bismuth therapy | Experimental | Drug: VAB-7Vonoprazan 20mg twice daily+Amoxicillin 1g three times daily+Bismuth 220mg twice daily for 7 days |
| 14-day Vonoprazan-Amoxicillin dual therapy | Active comparator | Drug: VA-14Vonoprazan 20mg twice daily and Amoxicillin 1g three times daily for 14 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 to 70 years, regardless of sex.
- Helicobacter pylori infection confirmed by ¹³C or ¹⁴C urea breath test within 1 month before enrollment.
- Chronic gastritis with H. pylori infection confirmed by endoscopy within 3 months, meeting the indications for eradication therapy in the Sixth National Consensus Report on the Management of Helicobacter pylori Infection (China), and willing to receive eradication treatment.
- No prior H. pylori eradication therapy.
- Written informed consent before participation.
Key exclusion criteria (7 listed)
- Known allergy or hypersensitivity to any study medication (vonoprazan, amoxicillin, or bismuth).
- Use of potassium-competitive acid blockers (P-CABs), proton pump inhibitors (PPIs), H₂ receptor antagonists, antibiotics, bismuth preparations, or probiotics within 4 weeks before enrollment.
- Pregnant or lactating women.
- Concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or anticoagulants during the study period.
- Presence of serious comorbid conditions that may interfere with study evaluation, including significant cardiac, pulmonary, hepatic, renal, metabolic, or psychiatric disorders, or malignancy.
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 |
|---|---|---|
| VAB-7Vonoprazan 20mg twice daily+Amoxicillin 1g three times daily+Bismuth 220mg twice daily for 7 days | Drug | 7-day Vonoprazan-High-dose Amoxicillin-Bismuth therapy |
| VA-14Vonoprazan 20mg twice daily and Amoxicillin 1g three times daily for 14 days | Drug | 14-day Vonoprazan-Amoxicillin dual therapy |
Primary outcome
H. pylori eradication rate
Time frame: 4-6 weeks after treatment completion
Rate of H. pylori successfully eradicated; The confirmation of H. pylori status was evaluated by Urea breath test.
3 secondary outcomes
Patient compliance
Time frame: 1 day after treatment completion
Adverse events
Time frame: For the 7-day intervention: assessment on Day 3 and Day 7; For the 14-day intervention: assessment on Day 7 and Day 14.
Cost-effectiveness ratio
Time frame: 1 day after the procedure
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 8 Apr 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing VAB-7 and VA-14 in people with Helicobacter Pylori, run by The First Affiliated Hospital with Nanjing Medical University 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 8 Apr 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Feng Ye, PhD (86+13815897873, fengye@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
H. pylori eradication rate (time frame: 4-6 weeks after treatment completion). 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 8 Apr 2026.