Clinical Evaluation of a 14day Modified Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori in a High Clarithromycin and Metronidazole Resistance Area Regarding Patients With Peptic Ulcer and Non Ulcer Dyspepsia

Summary

The goal of this clinical trial is to learn if a modified bismuth-containing therapy for the treatment of helicobacter pylori infection works to treat chronic helicobacter pylori related gastritis in adults treated either for first time or after a previous failure of another helicbacter erdication therapy. It will also learn about the safety and compliance of the modified bismuth containing therapy for helicobacter pylori. The main questions it aims to answer are: Does the modified bismuth-containing therapy for helicobacter pylori maintains a high eradication profile? What medical problems do participants have when taking the bismuth containing therapy? Researchers will present the eradication percentage of the modified bismuth containing therapy for helicobacter pylori in a difficult to treat population with a high profile of resistance to antibiotics for the treatment of helicobacter pylori separately for first time treated patients or patients with previous failures of other therapies. Participants will: Take the modified bismuth containing therapy which consists of four different medications (esomeprazole, amoxicillin, metronidazole, bismuth subcitrate) taken for 14 days in selected timepoints. Visit the clinic at the end of therapy for checkups and at 6 to 8 weeks after the end of therapy for final evaluation of completed eradication. Keep a diary of their symptoms and the number of medications taken.

Timeline

Start

2025-08-20

Primary completion

2026-05-01

Completion

2026-05-01

Publications

• Background Graham DY, Dore MP, Lu H. Understanding treatment guidelines with bismuth and non-bismuth quadruple Helicobacter pylori eradication therapies. Expert Rev Anti Infect Ther. 2018 Sep;16(9):679-687. doi: 10.1080/14787210.2018.1511427. Epub 2018 Aug 23.
• Background Han Z, Li Y, Kong Q, Liu J, Wang J, Wan M, Lin M, Lin B, Zhang W, Ding Y, Wang S, Mu Y, Duan M, Zuo X, Li YQ. Efficacy of bismuth for antibiotic-resistant Helicobacter pylori strains eradication: A systematic review and meta-analysis. Helicobacter. 2022 Dec;27(6):e12930. doi: 10.1111/hel.12930. Epub 2022 Sep 25.
• Background Megraud F. The challenge of Helicobacter pylori resistance to antibiotics: the comeback of bismuth-based quadruple therapy. Ther Adv Gastroenterol. 2012 Mar;5(2):103-9. doi: 10.1177/1756283X11432492.
• Background Tsay FW, Wu DC, Yu HC, Kao SS, Lin KH, Cheng JS, Wang HM, Chen WC, Sun WC, Tsai KW, Hsu PI. A Randomized Controlled Trial Shows that both 14-Day Hybrid and Bismuth Quadruple Therapies Cure Most Patients with Helicobacter pylori Infection in Populations with Moderate Antibiotic Resistance. Antimicrob Agents Chemother. 2017 Oct 24;61(11):e00140-17. doi: 10.1128/AAC.00140-17. Print 2017 Nov.
• Background Georgopoulos SD, Xirouchakis E, Liatsos C, Apostolopoulos P, Kasapidis P, Martinez-Gonzalez B, Laoudi F, Stoupaki M, Axiaris G, Sgouras D, Mentis A, Michopoulos S. Equivalence Trial of the Non-Bismuth 10-Day Concomitant and 14-Day Hybrid Therapies for Helicobacter pylori Eradication in High Clarithromycin Resistance Areas. Antibiotics (Basel). 2024 Mar 20;13(3):280. doi: 10.3390/antibiotics13030280.
• Background Georgopoulos SD, Xirouchakis E, Martinez-Gonzales B, Zampeli E, Grivas E, Spiliadi C, Sotiropoulou M, Petraki K, Zografos K, Laoudi F, Sgouras D, Mentis A, Kasapidis P, Michopoulos S. Randomized clinical trial comparing ten day concomitant and sequential therapies for Helicobacter pylori eradication in a high clarithromycin resistance area. Eur J Intern Med. 2016 Jul;32:84-90. doi: 10.1016/j.ejim.2016.04.011. Epub 2016 Apr 28.
• Background Olmedo L, Calvet X, Gene E, Bordin DS, Voynovan I, Castro-Fernandez M, Pabon-Carrasco M, Keco-Huerga A, Perez-Aisa A, Lucendo AJ, Rodrigo L, Sarsenbaeva AS, Khlinov IB, Fadieienko G, Zaytsev O, Lanas A, Martinez-Dominguez SJ, Alfaro E, Jonaitis L, Nunez O, Pellicano R, Hernandez L, Gridnyev O, Kupcinskas J, Gasbarrini A, Boltin D, Niv Y, Babayeva G, Marcos-Pinto R, Tepes B, Venerito M, Papp V, Lerang F, Leja M, Phull PS, Marlicz W, Doulberis M, Smith SM, Milivojevic V, Kunovsky L, Mestrovic A, Matysiak-Budnik T, Simsek H, Cano-Catala A, Puig I, Moreira L, Parra P, Nyssen OP, Megraud F, O'Morain C, Gisbert JP; Hp-EuReg investigators*. Evolution of the use, effectiveness and safety of bismuth-containing quadruple therapy for Helicobacter pylori infection between 2013 and 2021: results from the European registry on H. pylori management (Hp-EuReg). Gut. 2024 Dec 10;74(1):15-25. doi: 10.1136/gutjnl-2024-332804.
• Background Rokkas T, Gisbert JP, Malfertheiner P, Niv Y, Gasbarrini A, Leja M, Megraud F, O'Morain C, Graham DY. Comparative Effectiveness of Multiple Different First-Line Treatment Regimens for Helicobacter pylori Infection: A Network Meta-analysis. Gastroenterology. 2021 Aug;161(2):495-507.e4. doi: 10.1053/j.gastro.2021.04.012. Epub 2021 Apr 8.
• 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 Chen Q, Long X, Ji Y, Liang X, Li D, Gao H, Xu B, Liu M, Chen Y, Sun Y, Zhao Y, Xu G, Song Y, Yu L, Zhang W, Liu W, Graham DY, Lu H. Randomised controlled trial: susceptibility-guided therapy versus empiric bismuth quadruple therapy for first-line Helicobacter pylori treatment. Aliment Pharmacol Ther. 2019 Jun;49(11):1385-1394. doi: 10.1111/apt.15273. Epub 2019 Apr 24.

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