The study aims to test the efficacy of 7 days vs. 14 days of Vonoprazan-triple therapy in the eradication of Helicobacter Pylori infection in adolescents and young children.
After being informed about the study details, all eligible participants (or their legal guardians) will give informed written consent to be involved. After a one week screening, eligible participants will be randomized to Vonoprazan plus Amoxicillin plus Clarithromycin triple therapy for either 14 days (group 1), or 7 days (group 2) at a 1:1 ratio. After the end of therapy, H. Pylori eradication will be evaluated after 4 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
326
Participants will receive Vonoprazan 20 mg tablets twice daily before meals.
Participants will receive Amoxicillin 50 mg/kg/day capsules or suspension \[maximum daily dose: 2 g\].
Participants will receive Clarithromycin 20 mg/kg/day tablets or suspension \[maximum daily dose: 1 g\].
Faculty of Medicine, Alexandria University.
Alexandria, Egypt
H. Pylori eradication rate
Number of participants who will achieve a negative H. pylori antigen detection test after the end of therapy.
Time frame: 4 weeks after completion of treatment
Adverse events during treatment.
Type and frequency of treatment-related adverse effects in both arms
Time frame: From first dose of treatment until 7 or 14 days of treatment regimen assigned.
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