Helicobacter Pylori EradicationNCT06349486
Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy, Vonoprazan-amoxicillin Dual Therapy and Proton Pump Inhibitor-based Standard Triple Therapy for Hp Eradication
A study testing vonoprazan, amoxicillin, tripotassium dicitrate bismuthate, vonoprazan, amoxicillin and rabeprazole, amoxicillin, clarithromycin in people with Helicobacter Pylori Eradication, run by Kaohsiung Medical University at 1 site in Taiwan.
Trial summary
1. Compare the efficacies and safety of 14-day bismuth-amoxicillin-vonoprazan tiple therapy, 14-day vonoprazan dual therapy and 14-day rabeprazole triple therapy in the first-line treatment of H. pylori infection. 2. To investigate the impacts of antibiotic resistance of H. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Helicobacter Pylori Eradication
- What is being tested?
- vonoprazan, amoxicillin, tripotassium dicitrate bismuthate, vonoprazan, amoxicillin and rabeprazole, amoxicillin, clarithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Nov 2023to 31 Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old. (2) Subjects infected with Helicobacter pylori.
Who cannot join
- Those who have ever received Helicobacter pylori sterilization treatment.
- Those who are allergic to the drugs used in this research.
- Those who have had stomach surgery.
- Those with severe liver cirrhosis or uremia or malignant tumors.
- Women who are pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Hospital
Kaohsiung City, 807
Deng-Chyang Wu, MD,PHD, 886-7-3121101 ext. 7451, dechwu@yahoo.com
About this study
Official title: Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy, Vonoprazan-amoxicillin Dual Therapy and Proton Pump Inhibitor-based Standard Triple Therapy in the First-line Anti-H. Pylori Treatment
- Compare the efficacies and safety of 14-day bismuth-amoxicillin-vonoprazan tiple therapy, 14-day vonoprazan dual therapy and 14-day rabeprazole triple therapy in the first-line treatment of H. pylori infection.
- To investigate the impacts of antibiotic resistance of H. pylori as well as CYP3A4, CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of anti-H. pylori treatments.
Read the detailed description
For this multi-center, randomized, open-label, superiority trial, we will recruit 780 adult patients with H. pylori infection from ten medical centers or regional hospitals in Taiwan. Using a computer generated randomized sequence, we randomly allocate patients (1:1:1; block size of six) to either 14-day bismuth-amoxicillin-vonoprazan triple therapy, 14-day vonoprazan dual therapy, or 14-day rabeprazole-triple therapy. Patients are asked to return at the second week to assess drug adherence and adverse events. Post-treatment H. pylori status is assessed by 13C-urea breath test at week 6. Participants with failure of H. pylori eradication will randomly receive either 14-day vonoprazan-based or 14-day esomeprazole-based bismuth quadruple therapy. Finally, the rates of eradication and adverse events will be compared between groups by chi-square test. Additionally, the effects of antibiotic resistances of H. pylori as well as CYP3A4, CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of above first-line and second-line anti-H. pylori treatments are assessed by multivariate analysis.
- Conditions
- Helicobacter Pylori Eradication
- Being tested
- vonoprazan, amoxicillin, tripotassium dicitrate bismuthate, vonoprazan, amoxicillin, rabeprazole, amoxicillin, clarithromycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vonoprazan, amoxicillin, tripotassium dicitrate bismuthateDrug
bismuth-amoxicillin-vonoprazan triple therapy
vonoprazan, amoxicillinDrug
vonoprazan-amoxicillin dual therapy
rabeprazole, amoxicillin, clarithromycinDrug
proton pump inhibitor-based standard triple therapy
| Study group | Role | What they receive |
|---|---|---|
| bismuth-amoxicillin-vonoprazan triple therapy | Active comparator | vonoprazan 20mg twice a day + amoxicillin 750mg four times a day + tripotassium dicitrate bismuthate 300mg four times a day Receives: Drug: vonoprazan, amoxicillin, tripotassium dicitrate bismuthate |
| vonoprazan-amoxicillin dual therapy | Active comparator | vonoprazan 20mg twice a day + amoxicillin 750mg，Four times a day Receives: Drug: vonoprazan, amoxicillin |
| proton pump inhibitor-based standard triple therapy | Active comparator | rabeprazole 20mg twice a day + amoxicillin 1gm twice a day + clarithromycin 500mg twice a day Receives: Drug: rabeprazole, amoxicillin, clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the eradication rate of Helicobacter pylori
evalute eradication outcome by 13C urea breath test
Measured: 8 week after finishing study drugs
Secondary outcomes (1)
genotype analysis
CYP3A4, CYP2C19 and IL-1B -511 genotypes
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start28 Nov 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori EradicationStudies 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
- 1. bismuth-amoxicillin-vonoprazan triple therapy 2. vonoprazan-amoxicillin dual therapy 3. proton pump inhibitor-based standard triple therapy
- Masking
- None (open label)
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DENG-CHYANG WU, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349486
- Sponsor's protocol ID
- KMUHIRB-F(II)-20230179
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2024
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy, Vonoprazan-amoxicillin Dual Therapy and Proton Pump Inhibitor-based Standard Triple Therapy in the First-line Anti-H. Pylori Treatment
- ClinicalTrials.gov ID
- NCT06349486
- Acronym / sponsor ID
- KMUHIRB-F(II)-20230179
- Conditions
- Helicobacter Pylori Eradication
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Apr 2024 (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.
- Compare the efficacies and safety of 14-day bismuth-amoxicillin-vonoprazan tiple therapy, 14-day vonoprazan dual therapy and 14-day rabeprazole triple therapy in the first-line treatment of H. pylori infection.
- To investigate the impacts of antibiotic resistance of H. pylori as well as CYP3A4, CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of anti-H. pylori treatments.
Detailed description
For this multi-center, randomized, open-label, superiority trial, we will recruit 780 adult patients with H. pylori infection from ten medical centers or regional hospitals in Taiwan. Using a computer generated randomized sequence, we randomly allocate patients (1:1:1; block size of six) to either 14-day bismuth-amoxicillin-vonoprazan triple therapy, 14-day vonoprazan dual therapy, or 14-day rabeprazole-triple therapy. Patients are asked to return at the second week to assess drug adherence and adverse events. Post-treatment H. pylori status is assessed by 13C-urea breath test at week 6. Participants with failure of H. pylori eradication will randomly receive either 14-day vonoprazan-based or 14-day esomeprazole-based bismuth quadruple therapy. Finally, the rates of eradication and adverse events will be compared between groups by chi-square test. Additionally, the effects of antibiotic resistances of H. pylori as well as CYP3A4, CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of above first-line and second-line anti-H. pylori treatments are assessed by multivariate analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 1. bismuth-amoxicillin-vonoprazan triple therapy 2. vonoprazan-amoxicillin dual therapy 3. proton pump inhibitor-based standard triple therapy
| Arm | Type | Receives |
|---|---|---|
| bismuth-amoxicillin-vonoprazan triple therapy | Active comparator | Drug: vonoprazan, amoxicillin, tripotassium dicitrate bismuthatevonoprazan 20mg twice a day + amoxicillin 750mg four times a day + tripotassium dicitrate bismuthate 300mg four times a day |
| vonoprazan-amoxicillin dual therapy | Active comparator | Drug: vonoprazan, amoxicillinvonoprazan 20mg twice a day + amoxicillin 750mg，Four times a day |
| proton pump inhibitor-based standard triple therapy | Active comparator | Drug: rabeprazole, amoxicillin, clarithromycinrabeprazole 20mg twice a day + amoxicillin 1gm twice a day + clarithromycin 500mg twice a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- At least 18 years old. (2) Subjects infected with Helicobacter pylori.
Key exclusion criteria (5 listed)
- Those who have ever received Helicobacter pylori sterilization treatment.
- Those who are allergic to the drugs used in this research.
- Those who have had stomach surgery.
- Those with severe liver cirrhosis or uremia or malignant tumors.
- Women who are pregnant or breastfeeding.
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 |
|---|---|---|
| vonoprazan, amoxicillin, tripotassium dicitrate bismuthatebismuth-amoxicillin-vonoprazan triple therapy | Drug | bismuth-amoxicillin-vonoprazan triple therapy |
| vonoprazan, amoxicillinvonoprazan-amoxicillin dual therapy | Drug | vonoprazan-amoxicillin dual therapy |
| rabeprazole, amoxicillin, clarithromycinproton pump inhibitor-based standard triple therapy | Drug | proton pump inhibitor-based standard triple therapy |
Primary outcome
the eradication rate of Helicobacter pylori
Time frame: 8 week after finishing study drugs
evalute eradication outcome by 13C urea breath test
1 secondary outcome
genotype analysis
Time frame: 1 day
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 15 Jan 2026.
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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 study testing vonoprazan, amoxicillin, tripotassium dicitrate bismuthate, vonoprazan, amoxicillin and rabeprazole, amoxicillin, clarithromycin in people with Helicobacter Pylori Eradication, run by Kaohsiung Medical University at 1 site in Taiwan.
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 1 inclusion and 5 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 15 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 Taiwan. 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?
Contact Deng-Chyang Wu, MD, PHD (88673121101 ext. 7451, dechwu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the eradication rate of Helicobacter pylori (time frame: 8 week after finishing study drugs). 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 15 Jan 2026.