Helicobacter Pylori InfectionNCT07358130
Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy and Bismuth Quadruple Therapy
A study testing vonoprazan, tripotassium dicitrate bismuthate, amoxicilline and rabeprazole, tripotassium dicitrate bismuthate, tetracycline, metronidazole in people with Helicobacter Pylori Infection, run by Kaohsiung Medical University at 1 site in Taiwan.
Trial summary
(1) To compare the efficacy and safety of a 14-day bismuth-amoxicillin-vonoprazan triple therapy versus a 14-day bismuth-based quadruple therapy as first-line treatments for H. pylori infection, and (2) To investigate the influence of H. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- vonoprazan, tripotassium dicitrate bismuthate, amoxicilline and rabeprazole, tripotassium dicitrate bismuthate, tetracycline, metronidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 552 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Oct 2025to 31 Dec 2027
- 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
- Subjects with Helicobacter pylori infection
Who cannot join
- Subjects with known hypersensitivity to the study drug.
- Subjects with a history of gastric surgery.
- Subjects with severe liver cirrhosis or uremia.
- Subjects with a history of malignancy within the past five years.
- Pregnant or breastfeeding women.
- Subjects currently receiving treatment with atazanavir sulfate or rilpivirine hydrochloride.
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, 88673121101 ext. 7451, dechwu@yahoo.com
About this study
Official title: Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy and Bismuth Quadruple Therapy in the First-line Anti-Helicobacter Pylori Treatment
(1) To compare the efficacy and safety of a 14-day bismuth-amoxicillin-vonoprazan triple therapy versus a 14-day bismuth-based quadruple therapy as first-line treatments for H. pylori infection, and (2) To investigate the influence of H. pylori antibiotic resistance, along with host CYP3A4, CYP2C19, and IL-1B -511 genotypes, on the eradication efficacy of H. pylori therapies.
Read the detailed description
This multicenter, randomized, open-label, trial will enroll 552 adult patients with H. pylori infection from 12 medical centers or regional hospitals in Taiwan. Using a computer-generated randomization sequence (1:1 allocation; block size of four), participants will be assigned to receive either the 14-day bismuth-amoxicillin-vonoprazan triple therapy or the 14-day bismuth-rabeprazole-tetracycline-metronidazole quadruple therapy. Follow-up at week 2 will assess treatment adherence and adverse events. H. pylori status will be evaluated at week 6 using the C13-urea breath test. Eradication and adverse event rates will be compared between groups using the chi-square test. The impact of H. pylori antibiotic resistance and host CYP3A4, CYP2C19, and IL-1B -511 genotypes on treatment efficacy will be analyzed using multivariate models.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- vonoprazan, tripotassium dicitrate bismuthate, amoxicilline, rabeprazole, tripotassium dicitrate bismuthate, tetracycline, metronidazole
- Keywords
- Helicobacter pylori eradication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vonoprazan, tripotassium dicitrate bismuthate, amoxicillineDrug
Also called triple therapy
bismuth-amoxicillin-vonoprazan triple therapy
rabeprazole, tripotassium dicitrate bismuthate, tetracycline, metronidazoleDrug
Also called quadruple therapy
bismuth-based quadruple therapy
| Study group | Role | What they receive |
|---|---|---|
| bismuth-amoxicillin-vonoprazan triple therapy | Active comparator | vonoprazan 20mg twice a day +tripotassium dicitrate bismuthate 300mg four times a day +amoxicilline 750mg four times a day Receives: Drug: rabeprazole, tripotassium dicitrate bismuthate, tetracycline, metronidazole |
| bismuth-based quadruple therapy | Active comparator | rabeprazole 20mg twice a day+ tripotassium dicitrate bismuthate 300mg four times a day+ tetracycline 500mg four times a day+ metronidazole 250mg four times a day Receives: Drug: vonoprazan, tripotassium dicitrate bismuthate, amoxicilline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of Helicobacter pylori eradication
evaluate eradication by 13C urea breath test
Measured: 6 weeks after finishing study drugs
Evaluation of the safety of Helicobacter pylori eradication therapy
Drug-related adverse effects assessed by a standardized questionnaire
Measured: 14 days
Secondary outcomes (1)
genotype analysis
Genotype analysis (CYP3A4, CYP2C19, and IL-1B -511) will be performed using a blood sample collected once at study entry.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start21 Oct 2025
- Primary completion15 Nov 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies 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
- bismuth-amoxicillin-vonoprazan triple therapy
- Masking
- None (open label)
- Enrolment
- 552 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Kaohsiung Veterans General Hospital.
- Responsible party
- Principal investigator, DENG-CHYANG WU, Kaohsiung Medical University
- Investigators
- Deng-Chyang Wu, MD, PHD, Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358130
- Sponsor's protocol ID
- KMUHIRB-F(I)-20250254
- Status last verified
- Sep 2025
- First submitted
- 12 Dec 2025
- Last updated
- 22 Jan 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 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy and Bismuth Quadruple Therapy in the First-line Anti-Helicobacter Pylori Treatment
- ClinicalTrials.gov ID
- NCT07358130
- Acronym / sponsor ID
- KMUHIRB-F(I)-20250254
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori eradication
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 552 participants (estimated)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Collaborators
- Kaohsiung Veterans General Hospital.
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- 15 Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 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.
(1) To compare the efficacy and safety of a 14-day bismuth-amoxicillin-vonoprazan triple therapy versus a 14-day bismuth-based quadruple therapy as first-line treatments for H. pylori infection, and (2) To investigate the influence of H. pylori antibiotic resistance, along with host CYP3A4, CYP2C19, and IL-1B -511 genotypes, on the eradication efficacy of H. pylori therapies.
Detailed description
This multicenter, randomized, open-label, trial will enroll 552 adult patients with H. pylori infection from 12 medical centers or regional hospitals in Taiwan. Using a computer-generated randomization sequence (1:1 allocation; block size of four), participants will be assigned to receive either the 14-day bismuth-amoxicillin-vonoprazan triple therapy or the 14-day bismuth-rabeprazole-tetracycline-metronidazole quadruple therapy. Follow-up at week 2 will assess treatment adherence and adverse events. H. pylori status will be evaluated at week 6 using the C13-urea breath test. Eradication and adverse event rates will be compared between groups using the chi-square test. The impact of H. pylori antibiotic resistance and host CYP3A4, CYP2C19, and IL-1B -511 genotypes on treatment efficacy will be analyzed using multivariate models.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- bismuth-amoxicillin-vonoprazan triple therapy
| Arm | Type | Receives |
|---|---|---|
| bismuth-amoxicillin-vonoprazan triple therapy | Active comparator | Drug: rabeprazole, tripotassium dicitrate bismuthate, tetracycline, metronidazolevonoprazan 20mg twice a day +tripotassium dicitrate bismuthate 300mg four times a day +amoxicilline 750mg four times a day |
| bismuth-based quadruple therapy | Active comparator | Drug: vonoprazan, tripotassium dicitrate bismuthate, amoxicillinerabeprazole 20mg twice a day+ tripotassium dicitrate bismuthate 300mg four times a day+ tetracycline 500mg four times a day+ metronidazole 250mg four times 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)
- Subjects with Helicobacter pylori infection
Key exclusion criteria (6 listed)
- Subjects with known hypersensitivity to the study drug.
- Subjects with a history of gastric surgery.
- Subjects with severe liver cirrhosis or uremia.
- Subjects with a history of malignancy within the past five years.
- Pregnant or breastfeeding women.
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, tripotassium dicitrate bismuthate, amoxicillineAlso: triple therapybismuth-amoxicillin-vonoprazan triple therapy | Drug | bismuth-based quadruple therapy |
| rabeprazole, tripotassium dicitrate bismuthate, tetracycline, metronidazoleAlso: quadruple therapybismuth-based quadruple therapy | Drug | bismuth-amoxicillin-vonoprazan triple therapy |
Primary outcome
The rate of Helicobacter pylori eradication
Time frame: 6 weeks after finishing study drugs
evaluate eradication by 13C urea breath test
Evaluation of the safety of Helicobacter pylori eradication therapy
Time frame: 14 days
Drug-related adverse effects assessed by a standardized questionnaire
1 secondary outcome
genotype analysis
Time frame: baseline
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 22 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.
Deng-Chyang Wu, MD, PHD principal investigator
Kaohsiung Medical University
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, tripotassium dicitrate bismuthate, amoxicilline and rabeprazole, tripotassium dicitrate bismuthate, tetracycline, metronidazole in people with Helicobacter Pylori Infection, 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 6 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 22 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 rate of Helicobacter pylori eradication (time frame: 6 weeks after finishing study drugs). The study lists 2 primary outcomes in all. 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 22 Jan 2026.