Efficacy of Vonoprazan-based Rescue Therapy for H. Pylori Eradication
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vonoprazan based ET, Vonoprazan based SGT.
- Who it may be relevant to
- Registry conditions: HELICOBACTER PYLORI INFECTIONS. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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. 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.
Interventions
- Drug Vonoprazan based ET
Empirical therapy Based on drug history: Levofloxacin sequential therapy or bismuth quadruple therapy (10 or 14 days) or quadruple therapy - Drug Vonoprazan based SGT
Susceptibility testing guided therapy Based onsusceptibility test:Levofloxacin sequential therapy or bismuth quadruple therapy (10 or 14 days) or rifabutin quadruple therapy
Primary outcome measures
- Eradication rate by intention-to-treat analysis [Time frame: 6-8 weeks]
Secondary outcome measures (1)
- Eradication rate by per-protocol analysis and Frequency of adverse effects. [Time frame: 6-8 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- National Taiwan University Hospital — Taipei
Identifiers
NCT: NCT07130253 · 202506082MINA