Efficacy of Vonoprazan-based Rescue Therapy for H. Pylori Eradication

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational Taiwan University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vonoprazan based ET

    Drug

    Empirical therapy Based on drug history: Levofloxacin sequential therapy or bismuth quadruple therapy (10 or 14 days) or quadruple therapy

  • Vonoprazan based SGT

    Drug

    Susceptibility testing guided therapy Based onsusceptibility test:Levofloxacin sequential therapy or bismuth quadruple therapy (10 or 14 days) or rifabutin quadruple therapy

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: Empirical vonoprazan-based therapyExperimental treatment 1 intervention
Group B: Susceptibility-guided vonoprazan-based therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Eradication rate by intention-to-treat analysis

Eradication rate will be determined by urea breath test at least 6 weeks aftercompletion of treatment.

Time frame
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.

Time frame
6-8 weeks

Other outcomes

Sponsors and contacts

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