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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Vonoprazan based ET
DrugEmpirical therapy Based on drug history: Levofloxacin sequential therapy or bismuth quadruple therapy (10 or 14 days) or quadruple therapy
Vonoprazan based SGT
DrugSusceptibility testing guided therapy Based onsusceptibility test:Levofloxacin sequential therapy or bismuth quadruple therapy (10 or 14 days) or rifabutin quadruple therapy
Treatment groups
Trial outcomes
Primary outcomes
Eradication rate by intention-to-treat analysis
Eradication rate will be determined by urea breath test at least 6 weeks aftercompletion of treatment.
Secondary outcomes
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: