HELICOBACTER PYLORI INFECTIONSNCT07130253
Efficacy of Vonoprazan-based Rescue Therapy for H. Pylori Eradication
A study testing Vonoprazan based ET and Vonoprazan based SGT in people with HELICOBACTER PYLORI INFECTIONS, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
1. This study aims to compare the efficacy of empirical vonoprazan-based therapy versus susceptibility-guided vonoprazan-based therapy for third-line eradication of H. pylori. 2. 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?
- Vonoprazan based ET and Vonoprazan based SGT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Aug 2025to 30 Jun 2030
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Helicobacter pylori infected individuals who have failed at least two previous eradication therapies.
- Willing to undergo third-line eradication therapy.
- Subjects must be 20 years of age or older.
Who cannot join
- History of gastrectomy.
- Individuals unsuitable for the study medication, such as those with a history of allergy or severe adverse reactions to the study drugs, quinolone or fluoroquinolone antibiotics, or women who are pregnant or breastfeeding.
- Presence of severe acute or chronic diseases such as renal failure, liver cirrhosis, incurable malignant tumors, or a history of aortic aneurysm or dissection.
- Patients with chronic hepatitis (AST or ALT > 100 U/L).
- Unwillingness 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.
Yu-Chun Huang contact
About this study
- This study aims to compare the efficacy of empirical vonoprazan-based therapy versus susceptibility-guided vonoprazan-based therapy for third-line eradication of H. pylori.
- We also plan to explore the impact of eradication therapy on gut microbiota, fecal antibiotic resistance, and metabolic parameters before and after treatment.
Read the detailed description
Methods:
- Study design: Open-labeled, randomized controlled trial
- Participants: A total of 220 patients who have failed at least two previous H. pylori eradication treatments will be enrolled.
Determination of antibiotic resistance of H. pylori: Agar dilution test will be used to determine the minimum inhibitory concentrations of levofloxacin, tetracycline, rifabutin, and clarithromycin to guide the selection of antibiotics.
Treatment regimens and assignment: Eligible patients will be randomized to receive either one of the treatments (A) Empirical vonoprazan-based therapy or (B) Susceptibility-guided vonoprazan-based therapy
Outcome Measurement:
Primary End Point: Eradication rate by intention-to-treat analysis. Secondary End Point: 1. Eradication rate by per-protocol analysis; 2. Frequency of adverse effects.
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Being tested
- Vonoprazan based ET, Vonoprazan based SGT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vonoprazan based ETDrug
Empirical therapy Based on drug history: Levofloxacin sequential therapy or bismuth quadruple therapy (10 or 14 days) or quadruple therapy
Vonoprazan based SGTDrug
Susceptibility testing guided therapy Based onsusceptibility test:Levofloxacin sequential therapy or bismuth quadruple therapy (10 or 14 days) or rifabutin quadruple therapy
| Study group | Role | What they receive |
|---|---|---|
| Empirical vonoprazan-based therapy | Experimental | Not described Receives: Drug: Vonoprazan based ET |
| Susceptibility-guided vonoprazan-based therapy | Active comparator | Not described Receives: Drug: Vonoprazan based SGT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate by intention-to-treat analysis
Eradication rate will be determined by urea breath test at least 6 weeks aftercompletion of treatment.
Measured: 6-8 weeks
Secondary outcomes (1)
Eradication rate by per-protocol analysis and Frequency of adverse effects.
Eradication rate will be determined by urea breath test at least 6 weeks aftercompletion of treatment. A standard interview and questionaire will be used to assess 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 posted19 Aug 2025
- Study start18 Aug 2025 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2030 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jyh-Ming Liou, MD, PhD, Study director, National Taiwan University HospitalMei-Jyh Chen, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130253
- Sponsor's protocol ID
- 202506082MINA
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 19 Aug 2025
- 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 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Vonoprazan-based Rescue Therapy for H. Pylori Eradication
- ClinicalTrials.gov ID
- NCT07130253
- Acronym / sponsor ID
- 202506082MINA
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 18 Aug 2025 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 19 Aug 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.
- This study aims to compare the efficacy of empirical vonoprazan-based therapy versus susceptibility-guided vonoprazan-based therapy for third-line eradication of H. pylori.
- We also plan to explore the impact of eradication therapy on gut microbiota, fecal antibiotic resistance, and metabolic parameters before and after treatment.
Detailed description
Methods:
- Study design: Open-labeled, randomized controlled trial
- Participants: A total of 220 patients who have failed at least two previous H. pylori eradication treatments will be enrolled.
Determination of antibiotic resistance of H. pylori: Agar dilution test will be used to determine the minimum inhibitory concentrations of levofloxacin, tetracycline, rifabutin, and clarithromycin to guide the selection of antibiotics.
Treatment regimens and assignment: Eligible patients will be randomized to receive either one of the treatments (A) Empirical vonoprazan-based therapy or (B) Susceptibility-guided vonoprazan-based therapy
Outcome Measurement:
Primary End Point: Eradication rate by intention-to-treat analysis. Secondary End Point: 1. Eradication rate by per-protocol analysis; 2. Frequency of adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empirical vonoprazan-based therapy | Experimental | Drug: Vonoprazan based ET |
| Susceptibility-guided vonoprazan-based therapy | Active comparator | Drug: Vonoprazan based SGT |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Helicobacter pylori infected individuals who have failed at least two previous eradication therapies.
- Willing to undergo third-line eradication therapy.
- Subjects must be 20 years of age or older.
Key exclusion criteria (5 listed)
- History of gastrectomy.
- Individuals unsuitable for the study medication, such as those with a history of allergy or severe adverse reactions to the study drugs, quinolone or fluoroquinolone antibiotics, or women who are pregnant or breastfeeding.
- Presence of severe acute or chronic diseases such as renal failure, liver cirrhosis, incurable malignant tumors, or a history of aortic aneurysm or dissection.
- Patients with chronic hepatitis (AST or ALT > 100 U/L).
- Unwillingness to comply with the treatment plan or sign the informed consent form.
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 based ETEmpirical therapy Based on drug history: Levofloxacin sequential therapy or bismuth quadruple therapy (10 or 14 days) or quadruple therapy | Drug | Empirical vonoprazan-based therapy |
| Vonoprazan based SGTSusceptibility testing guided therapy Based onsusceptibility test:Levofloxacin sequential therapy or bismuth quadruple therapy (10 or 14 days) or rifabutin quadruple therapy | Drug | Susceptibility-guided vonoprazan-based therapy |
Primary outcome
Eradication rate by intention-to-treat analysis
Time frame: 6-8 weeks
Eradication rate will be determined by urea breath test at least 6 weeks aftercompletion of treatment.
1 secondary outcome
Eradication rate by per-protocol analysis and Frequency of adverse effects.
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 19 Aug 2025.
- 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.
Yu-Chun Huang contact
Jyh-Ming Liou, MD, PhD study director
National Taiwan University Hospital
Mei-Jyh Chen, MD, PhD principal investigator
National Taiwan University Hospital
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 based ET and Vonoprazan based SGT 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 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: opening soon, as of the sponsor's last update on 19 Aug 2025. 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 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 by intention-to-treat 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 19 Aug 2025.