HELICOBACTER PYLORI INFECTIONSPhase 3NCT07576959
Effect of Bismuth Add-on to Dual Therapy for Helicobacter Pylori Eradication
A Phase 3 study testing Bismuth Add-on to Vonoprazan Dual Therapy and Vonoprazan dual therapy in people with HELICOBACTER PYLORI INFECTIONS, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study aims to compare the efficacy and safety of a bismuth-supplemented 14-day vonoprazan-based dual therapy ( triple therapy) versus a 14-day vonoprazan-based dual therapy without bismuth for first-line H. pylori eradication. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- HELICOBACTER PYLORI INFECTIONS
- What is being tested?
- Bismuth Add-on to Vonoprazan Dual Therapy and Vonoprazan dual therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 990 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Apr 2026to 31 Dec 2032
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals infected with Helicobacter pylori who have not previously undergone eradication therapy.
- Individuals willing to receive first-line eradication therapy.
- Study participants must be 20 years of age or older.
Who cannot join
- Individuals with a history of gastrectomy (stomach removal surgery).
- Individuals unsuitable to receive the study drug (e.g., history of allergy or severe adverse effects to the study drug).
- Pregnant or breastfeeding women.
- Individuals with severe acute or chronic diseases, such as renal failure, liver cirrhosis, or incurable malignant tumors.
- Patients with chronic hepatitis (AST [Aspartate Aminotransferase] or ALT [Alanine Aminotransferase] > 100 U/L).
- Individuals unwilling to comply with the treatment plan or sign the informed consent form.
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
National Taiwan University Hospital
Taipei
Mei-Jyh Chen, MD, 886-2-23123456 Ext. 63541, migichen@ntuh.gov.tw
About this study
Official title: Effect of Bismuth Add-on to Vonoprazan-Amoxicillin Dual Therapy for Helicobacter Pylori Eradication - A Multicenter Randomized Controlled Trial
This study aims to compare the efficacy and safety of a bismuth-supplemented 14-day vonoprazan-based dual therapy ( triple therapy) versus a 14-day vonoprazan-based dual therapy without bismuth for first-line H. pylori eradication. Furthermore, the investigators will investigate the impact of these eradication regimens on the gut microbiota, the development of antibiotic resistance, and changes in metabolic syndrome indicators pre- and post-treatment.
Read the detailed description
Background: Although bismuth is not an antibiotic, it enhances antibiotic efficacy through multiple synergistic mechanisms. Currently, it remains unknown whether adding bismuth to a 14-day bismuth-vonoprazan-amoxicillin triple therapy is superior or non-inferior to the vonoprazan-amoxicillin dual therapy alone.
Objectives: This study aims to compare the efficacy and safety of a bismuth-supplemented 14-day vonoprazan-based triple therapy versus a 14-day vonoprazan-based dual therapy without bismuth for first-line H. pylori eradication.
Hypothesis: The investigators hypothesize that the efficacy of a 14-day bismuth-vonoprazan triple therapy is superior or non-inferior to that of a 14-day vonoprazan-based dual therapy without bismuth.
Methods:
Study Design: An open-label, randomized controlled trial (RCT). Participants: The investigators intend to recruit 990 treatment-naïve patients with confirmed H. pylori infection.
Intervention and Randomization: Eligible participants will be randomized into one of two groups:
- Group A: 14-day bismuth-vonoprazan triple therapy.
- Group B: 14-day vonoprazan-based dual therapy (without bismuth).
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Being tested
- Bismuth Add-on to Vonoprazan Dual Therapy, Vonoprazan dual therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bismuth Add-on to Vonoprazan Dual TherapyDrug
bismuth, vonoprazan and amoxicillin for 14 days
Vonoprazan dual therapyDrug
vonoprazan and amoxicillin for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Bismuth Add-on to Vonoprazan Dual Therapy | Experimental | 14-day bismuth-vonoprazan-amoxicillin triple therapy Receives: Drug: Bismuth Add-on to Vonoprazan Dual Therapy |
| Vonoprazan Dual Therapy | Active comparator | 14-day vonoprazan-based dual therapy (without bismuth). Receives: Drug: Vonoprazan dual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate determined by Intention-to-Treat (ITT) analysis
Eradication rate will be determined by urea breath test at least 6 weeks later after completion of treatment.
Measured: 6-8 weeks
Secondary outcomes (1)
Per-protocol (PP) eradication rate; adverse event profiles
Eradication rate will be determined by urea breath test at least 6 weeks later after completion of treatment. A standard interview and questionaire will be used toassess the adverse effects.
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start8 Apr 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HELICOBACTER PYLORI INFECTIONSStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 990 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576959
- Sponsor's protocol ID
- 202602016MINC
- Status last verified
- Apr 2026
- First submitted
- 27 Apr 2026
- Last updated
- 8 May 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 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bismuth Add-on to Vonoprazan-Amoxicillin Dual Therapy for Helicobacter Pylori Eradication - A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07576959
- Acronym / sponsor ID
- 202602016MINC
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 990 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 8 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 8 May 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.
This study aims to compare the efficacy and safety of a bismuth-supplemented 14-day vonoprazan-based dual therapy ( triple therapy) versus a 14-day vonoprazan-based dual therapy without bismuth for first-line H. pylori eradication. Furthermore, the investigators will investigate the impact of these eradication regimens on the gut microbiota, the development of antibiotic resistance, and changes in metabolic syndrome indicators pre- and post-treatment.
Detailed description
Background: Although bismuth is not an antibiotic, it enhances antibiotic efficacy through multiple synergistic mechanisms. Currently, it remains unknown whether adding bismuth to a 14-day bismuth-vonoprazan-amoxicillin triple therapy is superior or non-inferior to the vonoprazan-amoxicillin dual therapy alone.
Objectives: This study aims to compare the efficacy and safety of a bismuth-supplemented 14-day vonoprazan-based triple therapy versus a 14-day vonoprazan-based dual therapy without bismuth for first-line H. pylori eradication.
Hypothesis: The investigators hypothesize that the efficacy of a 14-day bismuth-vonoprazan triple therapy is superior or non-inferior to that of a 14-day vonoprazan-based dual therapy without bismuth.
Methods:
Study Design: An open-label, randomized controlled trial (RCT). Participants: The investigators intend to recruit 990 treatment-naïve patients with confirmed H. pylori infection.
Intervention and Randomization: Eligible participants will be randomized into one of two groups:
- Group A: 14-day bismuth-vonoprazan triple therapy.
- Group B: 14-day vonoprazan-based dual therapy (without bismuth).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bismuth Add-on to Vonoprazan Dual Therapy | Experimental | Drug: Bismuth Add-on to Vonoprazan Dual Therapy14-day bismuth-vonoprazan-amoxicillin triple therapy |
| Vonoprazan Dual Therapy | Active comparator | Drug: Vonoprazan dual therapy14-day vonoprazan-based dual therapy (without bismuth). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals infected with Helicobacter pylori who have not previously undergone eradication therapy.
- Individuals willing to receive first-line eradication therapy.
- Study participants must be 20 years of age or older.
Key exclusion criteria (6 listed)
- Individuals with a history of gastrectomy (stomach removal surgery).
- Individuals unsuitable to receive the study drug (e.g., history of allergy or severe adverse effects to the study drug).
- Pregnant or breastfeeding women.
- Individuals with severe acute or chronic diseases, such as renal failure, liver cirrhosis, or incurable malignant tumors.
- Patients with chronic hepatitis (AST [Aspartate Aminotransferase] or ALT [Alanine Aminotransferase] > 100 U/L).
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 |
|---|---|---|
| Bismuth Add-on to Vonoprazan Dual Therapybismuth, vonoprazan and amoxicillin for 14 days | Drug | Bismuth Add-on to Vonoprazan Dual Therapy |
| Vonoprazan dual therapyvonoprazan and amoxicillin for 14 days | Drug | Vonoprazan Dual Therapy |
Primary outcome
Eradication rate determined by Intention-to-Treat (ITT) analysis
Time frame: 6-8 weeks
Eradication rate will be determined by urea breath test at least 6 weeks later after completion of treatment.
1 secondary outcome
Per-protocol (PP) eradication rate; adverse event profiles
Time frame: 6-8 weeks
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 May 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 Phase 3 study testing Bismuth Add-on to Vonoprazan Dual Therapy and Vonoprazan dual therapy in people with HELICOBACTER PYLORI INFECTIONS, run by National Taiwan University Hospital 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 3 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 8 May 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Mei-Jyh Chen, MD, PhD (886-2-23123456 Ext. 265427, migichen@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication rate determined by Intention-to-Treat (ITT) analysis (time frame: 6-8 weeks). 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 May 2026.