NCT07130253

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• HELICOBACTER PYLORI INFECTIONS

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-08-18
• Primary completion: 2028-06-30
• Completion: 2030-06-30
• First posted: 2025-08-19
• Last updated: 2025-08-19

Locations

1 site across 1 country: Taiwan