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.
Weight ≥35 kg.
Biopsy-confirmed active H. pylori infection by histology.
Treatment-naïve or documented prior H. pylori eradication failure.
Able to provide informed assent/consent, with parental/legal guardian consent as applicable.
Known allergy or hypersensitivity to penicillin or amoxicillin.
Significant hepatic or renal impairment.
Pregnancy
Any medical or social condition that, in the opinion of the PI, would interfere with safe participation or study completion.
Single group
Vonoprazan
DrugVonoprazan 20 mg tablet will be administered orally twice daily for 14 days in combination with amoxicillin for the treatment of Helicobacter pylori infection.
Amoxicillin
DrugAmoxicillin 1000 mg will be administered orally three times daily for 14 days in combination with vonoprazan for the treatment of Helicobacter pylori infection.
Helicobacter Pylori Eradication Rate
The proportion of participants with successful Helicobacter pylori eradication, defined as a negative monoclonal stool antigen test following completion of vonoprazan-amoxicillin dual therapy.
Incidence and Severity of Adverse Events
Number and proportion of participants experiencing adverse events, including assessment of severity and relationship to study treatment.
Treatment Adherence
Proportion of participants who complete the prescribed 14-day vonoprazan-amoxicillin treatment regimen.
Change in Gastrointestinal Symptoms
Change from baseline in gastrointestinal symptoms, including abdominal pain or discomfort, bloating, nausea, bowel movement frequency and consistency, and other relevant symptoms, assessed using the study symptom questionnaire.
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:
