Faculty of Medicine, Alexandria University.
Alexandria, Egypt
NCT Number: NCT06576882
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.
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Notify Me10 year–18 year
All sexes
Interventional
Phase 3
Alexandria, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive Vonoprazan 20 mg tablets twice daily before meals.
Other names: Vonacidan, Tavoniza, Vondalous, Vonaspire, Vonseca
Participants will receive Amoxicillin 50 mg/kg/day capsules or suspension [maximum daily dose: 2 g].
Other names: Emox, Ibiamox, Amoxicid
Participants will receive Clarithromycin 20 mg/kg/day tablets or suspension [maximum daily dose: 1 g].
Other names: Klacid, Klarithro, Klarimix, Infectocure
Time frame: 4 weeks after completion of treatment
Number of participants who will achieve a negative H. pylori antigen detection test after the end of therapy.
Time frame: From first dose of treatment until 7 or 14 days of treatment regimen assigned.
Type and frequency of treatment-related adverse effects in both arms
Alexandria University
Other
7-day Versus 14-day Vonoprazan-based Triple Therapy for Eradication of H. Pylori in Adolescents: A Randomized Controlled Trial
Acronym: VOTE-HP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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