[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659195":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":33,"studyPopulation":26,"armGroups":34,"interventions":42,"overallOfficials":52,"centralContacts":56,"locations":26,"responsibleParty":66,"collaborators":26,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":26,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":26,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":94,"whyStopped":26,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":26},{"fullName":5,"class":6},"Boston Children's Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"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.","6 to 8 weeks after completion of the 14 day treatment regimen",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"Incidence and Severity of Adverse Events","Number and proportion of participants experiencing adverse events, including assessment of severity and relationship to study treatment.","From initiation of treatment through the final study safety assessment.",{"measure":19,"description":20,"timeFrame":21},"Treatment Adherence","Proportion of participants who complete the prescribed 14-day vonoprazan-amoxicillin treatment regimen.","Through completion of the 14-day treatment period.",{"measure":23,"description":24,"timeFrame":25},"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.","Baseline to end of the 14-day treatment period",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"NA","SINGLE_GROUP","TREATMENT",{"masking":32,"maskingDescription":26,"whoMasked":26},"NONE","Helicobacter pylori (H. pylori) infection is one of the most common chronic bacterial infections worldwide and is a major cause of chronic gastritis and peptic ulcer disease and an important risk factor for gastric malignancy. In the United States, the prevalence of H. pylori infection is estimated to be approximately 35%, with disproportionately higher rates among racial and ethnic minority populations and children from lower socioeconomic backgrounds. These disparities may contribute to persistent infection and increased disease burden.\n\nSuccessful H. pylori eradication depends on several factors, including bacterial antimicrobial susceptibility, adequate gastric acid suppression, treatment adherence, and optimized antibiotic dosing. Increasing antimicrobial resistance, particularly to clarithromycin, has substantially reduced the effectiveness of conventional proton pump inhibitor (PPI)-based triple therapy and has increased the need for effective treatment strategies that limit unnecessary antibiotic exposure.\n\nCurrent pediatric treatment approaches emphasize optimized acid suppression and antibiotic dosing to maximize eradication while minimizing unnecessary antibiotic exposure. At Boston Children's Hospital (BCH), treatment is selected based on antimicrobial susceptibility when available, medication availability and formulation, medication tolerance, allergies, and other patient-specific factors. When clarithromycin susceptibility is unknown, empiric treatment commonly involves a 14-day bismuth-based multidrug regimen. Although effective, this approach requires participants to take multiple medications several times per day, creating a substantial treatment burden for pediatric patients and their families. This complexity may contribute to poor adherence or failure to complete therapy, potentially reducing the likelihood of successful eradication and contributing to antimicrobial resistance. Other treatment regimens may be considered depending on antimicrobial susceptibility and individual clinical circumstances, but established treatment options for children remain limited.\n\nPotassium-competitive acid blockers (PCABs) provide rapid, potent, and sustained gastric acid suppression and are not affected by CYP2C19 metabolism in the same manner as PPIs. Vonoprazan, a PCAB, has demonstrated non-inferior or superior H. pylori eradication rates compared with PPI-based regimens in adults and is approved by the U.S. Food and Drug Administration in combination with amoxicillin, with or without clarithromycin, for the treatment of H. pylori infection in adults. Vonoprazan-based therapy may therefore provide an opportunity to simplify treatment while maintaining effective acid suppression and reducing exposure to additional antibiotics.\n\nAlthough pediatric data on vonoprazan-based treatment are emerging, published experience has been derived predominantly from Asian populations, and data evaluating vonoprazan-based therapy in U.S. children and adolescents remain limited. A small published case report has described successful eradication and favorable tolerability with vonoprazan-amoxicillin dual therapy in children with refractory, antimicrobial-resistant H. pylori infection. These findings support further evaluation of this simplified regimen earlier in the treatment course.\n\nThis prospective, single-center, open-label, single-arm, investigator-initiated therapeutic clinical trial will evaluate vonoprazan-amoxicillin dual therapy in U.S. adolescents with biopsy-confirmed H. pylori infection. The primary objective is to evaluate the efficacy of the regimen for H. pylori eradication. The study hypothesis is that vonoprazan-amoxicillin dual therapy will achieve an H. pylori eradication rate of at least 90%. The study will also evaluate safety, tolerability, treatment adherence, and changes in gastrointestinal symptoms.\n\nThe study consists of three phases. During screening, eligibility will be confirmed following biopsy-confirmed H. pylori infection identified during routine clinical care. Informed consent and assent, as applicable, will be obtained, and baseline assessments will be completed.\n\nDuring the treatment phase, participants will receive open-label vonoprazan plus amoxicillin for 14 days. Treatment adherence and adverse events will be assessed during the study.\n\nDuring follow-up, participants will undergo testing for H. pylori eradication 6 to 8 weeks after completion of therapy using a monoclonal stool antigen test. Participants will also complete the protocol-specified final safety assessment and study closeout.\n\nThis study is intended to generate prospective U.S. pediatric data on the efficacy, safety, tolerability, and feasibility of vonoprazan-amoxicillin dual therapy and to inform future evidence-based treatment recommendations for adolescents with H. pylori infection.",[35],{"label":36,"type":37,"description":38,"interventionNames":39},"Vonoprazan and Amoxicillin Dual Therapy","EXPERIMENTAL","Participants will receive vonoprazan 20 mg twice daily (BID) and amoxicillin 1 g three times daily (TID) for 14 days.",[40,41],"Drug: Vonoprazan","Drug: Amoxicillin",[43,48],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":26},"DRUG","Vonoprazan","Vonoprazan 20 mg tablet will be administered orally twice daily for 14 days in combination with amoxicillin for the treatment of Helicobacter pylori infection.",[36],{"type":44,"name":49,"description":50,"armGroupLabels":51,"otherNames":26},"Amoxicillin","Amoxicillin 1000 mg will be administered orally three times daily for 14 days in combination with vonoprazan for the treatment of Helicobacter pylori infection.",[36],[53],{"name":54,"affiliation":5,"role":55},"Silvana F Bonilla, MD, MS","PRINCIPAL_INVESTIGATOR",[57,61],{"name":54,"role":58,"phone":59,"phoneExt":26,"email":60},"CONTACT","781-216-2822","silvana.bonilla@childrens.harvard.edu",{"name":62,"role":58,"phone":63,"phoneExt":64,"email":65},"Eunice Newbert","617-355-6000","55308","Eunice.Newbert@childrens.harvard.edu",{"type":55,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Silvana Bonilla","Assistant Professor of Pediatrics Harvard Medical School","100659195","phase-2-vonoprazan-amoxicillin-dual-therapy-for-helicobacter-pylori-infection-in-united-states-adolescents-100659195",false,"NCT07860112","Vonoprazan-Amoxicillin Dual Therapy for Helicobacter Pylori Infection in United States Adolescents","Efficacy and Safety of Vonoprazan-Amoxicillin Dual Therapy for the Treatment of Helicobacter Pylori Infection in U.S. Adolescents: A Prospective Open-Label Study","Inclusion Criteria:\n\n* Weight ≥35 kg.\n* Biopsy-confirmed active H. pylori infection by histology.\n* Treatment-naïve or documented prior H. pylori eradication failure.\n* Able to provide informed assent\u002Fconsent, with parental\u002Flegal guardian consent as applicable.\n* No use of proton pump inhibitors or antibiotics within 4 weeks before enrollment.\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to penicillin or amoxicillin.\n* Significant hepatic or renal impairment.\n* Pregnancy\n* Any medical or social condition that, in the opinion of the PI, would interfere with safe participation or study completion.","ALL","10 Years","18 Years",{"count":80,"type":81},55,"ESTIMATED","INTERVENTIONAL",[84],"PHASE2","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.\n\nCurrent 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.\n\nThis 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.\n\nThe 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.",[87],"Helicobacter Pylori Infection",[89,90,91,92,93],"Helicobacter pylori","Vonoprazan-Amoxicillin Dual Therapy","Potassium-Competitive Acid Blocker","PCAB","Pediatric H. pylori","NOT_YET_RECRUITING","2026-10-02",{"date":97,"type":98},"2026-10-06","ACTUAL",{"date":100,"type":81},"2026-11",{"date":102,"type":81},"2027-12",{"name":5,"class":6}]