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

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.

Timeline

Start

2026-11

Primary completion

2027-12

Completion

2027-12

Publications

• Background 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.
• Background Fernandez-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.
• Background Fallone 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.
• Background Harris 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.
• Background Andrews 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.
• Background Graham 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.
• Background Bonilla 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.
• Background Herzlinger 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.
• Background Homan 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.
• Background Cardenas 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.
• Background Gotoda 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.
• Background Kaji 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.
• Background Kakiuchi 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.
• Background Kusano 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.
• Background Kakiuchi 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.
• Background Chey WD, Howden CW, Moss SF, Morgan DR, Greer KB, Grover S, Shah SC. ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. Am J Gastroenterol. 2024 Sep 1;119(9):1730-1753. doi: 10.14309/ajg.0000000000002968. Epub 2024 Sep 4.
• Background Malfertheiner P, Megraud F, Rokkas T, Gisbert JP, Liou JM, Schulz C, Gasbarrini A, Hunt RH, Leja M, O'Morain C, Rugge M, Suerbaum S, Tilg H, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study group. Management of Helicobacter pylori infection: the Maastricht VI/Florence consensus report. Gut. 2022 Aug 11;71(9):1724-1762. doi: 10.1136/gutjnl-2022-327745.
• Background Patel A, Laine L, Moayyedi P, Wu J. AGA Clinical Practice Update on Integrating Potassium-Competitive Acid Blockers Into Clinical Practice: Expert Review. Gastroenterology. 2024 Nov;167(6):1228-1238. doi: 10.1053/j.gastro.2024.06.038. Epub 2024 Sep 11.

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Indications