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

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.

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.