Clinical Research Directory

Vonoprazan-Amoxicillin Dual Therapy for Helicobacter Pylori Infection in United States Adolescents

Sponsor: Boston Children's Hospital

Summary

Helicobacter pylori (H. pylori) is a common bacterial infection of the stomach that can cause chronic stomach inflammation, ulcers, and other digestive problems. The infection is more common among some racial and ethnic minority groups and people from lower-income households, contributing to ongoing health disparities. Current treatment for H. pylori usually requires multiple medications, including antibiotics and acid-suppressing drugs. However, increasing antibiotic resistance has made some standard treatments less effective and can lead to treatment failure. There is a need for simpler, effective treatment options that use fewer antibiotics while maintaining high cure rates. This study will evaluate a treatment consisting of two medications: vonoprazan, an acid-suppressing medication, and amoxicillin, an antibiotic. Vonoprazan provides strong and consistent acid suppression, which may improve the effectiveness of amoxicillin in eliminating H. pylori. Studies in adults and limited studies in children have shown promising results, but this treatment has not been well studied as an initial treatment for adolescents in the United States. The purpose of this study is to determine whether vonoprazan plus amoxicillin is a safe, effective, and practical first-line treatment for adolescents with H. pylori infection. Participants will receive the study treatment and undergo follow-up testing to determine whether the infection has been eradicated. The results may help inform future treatment recommendations and provide additional treatment options for children and adolescents with H. pylori infection.

Official title: Efficacy and Safety of Vonoprazan-Amoxicillin Dual Therapy for the Treatment of Helicobacter Pylori Infection in U.S. Adolescents: A Prospective Open-Label Study

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