Helicobacter Pylori InfectionPhase 2NCT07860112
Vonoprazan-Amoxicillin Dual Therapy for Helicobacter Pylori Infection in United States Adolescents
A Phase 2 study testing Vonoprazan and Amoxicillin in people with Helicobacter Pylori Infection, run by Boston Children's Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Vonoprazan and Amoxicillin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
- No use of proton pump inhibitors or antibiotics within 4 weeks before enrollment.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read more
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.
Read the detailed description
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.
Successful 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.
Current 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.
Potassium-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.
Although 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.
This 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.
The 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.
During 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.
During 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.
This 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.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Vonoprazan, Amoxicillin
- Keywords
- Helicobacter pylori, Vonoprazan-Amoxicillin Dual Therapy, Potassium-Competitive Acid Blocker, PCAB, Pediatric H. pylori
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VonoprazanDrug
Vonoprazan 20 mg tablet will be administered orally twice daily for 14 days in combination with amoxicillin for the treatment of Helicobacter pylori infection.
AmoxicillinDrug
Amoxicillin 1000 mg will be administered orally three times daily for 14 days in combination with vonoprazan for the treatment of Helicobacter pylori infection.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Vonoprazan; Drug: Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 to 8 weeks after completion of the 14 day treatment regimen
Secondary outcomes (3)
Incidence and Severity of Adverse Events
Number and proportion of participants experiencing adverse events, including assessment of severity and relationship to study treatment.
Measured: From initiation of treatment through the final study safety assessment.
Treatment Adherence
Proportion of participants who complete the prescribed 14-day vonoprazan-amoxicillin treatment regimen.
Measured: Through completion of the 14-day treatment period.
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.
Measured: Baseline to end of the 14-day treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvana Bonilla, Boston Children's Hospital
- Investigators
- Silvana F Bonilla, MD, MS, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860112
- Sponsor's protocol ID
- IRB-P00055389
- Status last verified
- Oct 2026
- First submitted
- 11 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared because the study does not include a protocol-approved plan for sharing individual-level participant data with researchers outside the study team. Study findings will be reported in aggregate to protect participant confidentiality.
Publications
Chey WD, Megraud F, Laine L, Lopez LJ, Hunt BJ, Howden CW. Vonoprazan Triple and Dual Therapy for Helicobacter pylori Infection in the United States and Europe: Randomized Clinical Trial. Gastroenterology. 2022 Sep;163(3):608-619. doi: 10.1053/j.gastro.2022.05.055. Epub 2022 Jun 6.
PubMed 35679950Fernandez-Salazar L, Campillo A, Rodrigo L, Perez-Aisa A, Gonzalez-Santiago JM, Segarra Ortega X, Denkovski M, Brglez Jurecic N, Bujanda L, Gomez Rodriguez BJ, Ortuno J, Georgopoulos S, Jonaitis L, Puig I, Nyssen OP, Megraud F, O'Morain C, Gisbert JP. Effectiveness and Safety of High-Dose Dual Therapy: Results of the European Registry on the Management of Helicobacterpylori Infection (Hp-EuReg). J Clin Med. 2022 Jun 20;11(12):3544. doi: 10.3390/jcm11123544.
PubMed 35743627Fallone CA. The Current Role of Vonoprazan in Helicobacter pylori Treatment. Gastroenterology. 2022 Sep;163(3):572-574. doi: 10.1053/j.gastro.2022.06.076. Epub 2022 Jun 30. No abstract available.
PubMed 35780869Harris DM, Stancampiano FF, Burton MC, Moyer AM, Schuh MJ, Valery JR, Bi Y. Use of Pharmacogenomics to Guide Proton Pump Inhibitor Therapy in Clinical Practice. Dig Dis Sci. 2021 Dec;66(12):4120-4127. doi: 10.1007/s10620-020-06814-1. Epub 2021 Jan 21.
PubMed 33475867Andrews C, Herzlinger M, Riaz M, Liu E, Chan C, Bonilla S. Impact of medication dosage on Helicobacter pylori eradication rates among pediatric patients. J Pediatr Gastroenterol Nutr. 2024 Jul;79(1):35-41. doi: 10.1002/jpn3.12242. Epub 2024 May 8.
PubMed 38720566Graham DY, Liou JM. Primer for Development of Guidelines for Helicobacter pylori Therapy Using Antimicrobial Stewardship. Clin Gastroenterol Hepatol. 2022 May;20(5):973-983.e1. doi: 10.1016/j.cgh.2021.03.026. Epub 2021 Mar 26.
PubMed 33775895Bonilla S, Mitchell PD, Mansuri I. Low Adherence to Society Guidelines for the Management of Helicobacter Pylori Among Pediatric Gastroenterologists. J Pediatr Gastroenterol Nutr. 2021 Aug 1;73(2):178-183. doi: 10.1097/MPG.0000000000002976.
PubMed 34402809Herzlinger M, Dannheim K, Riaz M, Liu E, Bousvaros A, Bonilla S. Helicobacter pylori Antimicrobial Resistance in a Pediatric Population From the New England Region of the United States. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3458-3460.e2. doi: 10.1016/j.cgh.2023.02.026. Epub 2023 Mar 3. No abstract available.
PubMed 36871769Homan M, Jones NL, Bontems P, Carroll MW, Czinn SJ, Gold BD, Goodman K, Harris PR, Jerris R, Kalach N, Kori M, Megraud F, Rowland M, Tavares M; on behalf of ESPGHAN/NASPGHAN. Updated joint ESPGHAN/NASPGHAN guidelines for management of Helicobacter pylori infection in children and adolescents (2023). J Pediatr Gastroenterol Nutr. 2024 Sep;79(3):758-785. doi: 10.1002/jpn3.12314. Epub 2024 Aug 15.
PubMed 39148213Cardenas Fernandez MC, Ruiz Arellanos K, Bonilla S. Role of Vonoprazan-Amoxicillin Dual Therapy in Pediatric Refractory Helicobacter Pylori Infection in Children: Early Experience From A Single-Center Case Series. ACG Case Rep J. 2025 Oct 27;12(10):e01870. doi: 10.14309/crj.0000000000001870. eCollection 2025 Oct.
PubMed 41159012Gotoda T, Kusano C, Suzuki S, Horii T, Ichijima R, Ikehara H. Clinical impact of vonoprazan-based dual therapy with amoxicillin for H. pylori infection in a treatment-naive cohort of junior high school students in Japan. J Gastroenterol. 2020 Oct;55(10):969-976. doi: 10.1007/s00535-020-01709-4. Epub 2020 Jul 14.
PubMed 32666199Kaji E, Yoden A, Otani M, Okuhira T, Aomatsu T, Tamai H, Ashida A. Helicobacter pylori test-and-treat strategy for second-year junior high school students aimed at the prevention of gastric cancer in Takatsuki City. Helicobacter. 2020 Aug;25(4):e12696. doi: 10.1111/hel.12696. Epub 2020 Apr 30.
PubMed 32352203Kakiuchi T, Matsuo M, Endo H, Nakayama A, Sato K, Takamori A, Sasaki K, Takasaki M, Hara M, Sakata Y, Okuda M, Kikuchi S, Eguchi Y, Takahashi H, Anzai K, Fujimoto K. A Helicobacter pylori screening and treatment program to eliminate gastric cancer among junior high school students in Saga Prefecture: a preliminary report. J Gastroenterol. 2019 Aug;54(8):699-707. doi: 10.1007/s00535-019-01559-9. Epub 2019 Feb 15.
PubMed 30770975Kusano C, Gotoda T, Suzuki S, Ikehara H, Moriyama M. Safety of first-line triple therapy with a potassium-competitive acid blocker for Helicobacter pylori eradication in children. J Gastroenterol. 2018 Jun;53(6):718-724. doi: 10.1007/s00535-017-1406-2. Epub 2017 Nov 7.
PubMed 29110085Kakiuchi T, Matsuo M, Endo H, Sakata Y, Esaki M, Noda T, Imamura I, Hashiguchi K, Ogata S, Fujioka Y, Hanada K, Fukuda K, Yoshimura M, Kajiwara T, Yamamoto K, Yamaguchi D, Kawakubo H, Matsunaga T, Sumino M, Matsunaga K, Muro E, Watanabe A, Fujimoto K. Efficacy and safety of vonoprazan-based regimen for Helicobacter pylori eradication therapy in Japanese adolescents: a prospective multicenter study. J Gastroenterol. 2023 Mar;58(3):196-204. doi: 10.1007/s00535-022-01942-z. Epub 2022 Dec 17.
PubMed 36528706