Optimized Bismuth Quadruple Therapy vs Triple Standard Therapy for Helicobacter Pylori Eradication

Summary

This study have as primary aim "To compare the H. pylori eradication rate between the quadruple bismuth therapy versus the standard triple therapy recommended by the AUGE Clinical Guidelines for Helicobacter pylori eradication treatment in peptic ulcer patients." Briefly, this is a randomized, multicenter, controlled, double-blind clinical trial with two parallel arms. The control group will receive the current Standard Triple Therapy for the eradication of H. pylori. It consists of omeprazole + amoxicillin + clarithromycin for 14 days. The intervention group will be administered Quadruple Therapy with Bismuth, which consists in esomeprazole + amoxicillin + metronidazole + bismuth subsalicylate for 14 days

Timeline

Start

2022-10-17

Primary completion

2023-10-30

Completion

2024-01-30

Publications

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• Background Tshibangu-Kabamba E, Yamaoka Y. Helicobacter pylori infection and antibiotic resistance - from biology to clinical implications. Nat Rev Gastroenterol Hepatol. 2021 Sep;18(9):613-629. doi: 10.1038/s41575-021-00449-x. Epub 2021 May 17.
• Background Ierardi E, Losurdo G, Fortezza RF, Principi M, Barone M, Leo AD. Optimizing proton pump inhibitors in Helicobacter pylori treatment: Old and new tricks to improve effectiveness. World J Gastroenterol. 2019 Sep 14;25(34):5097-5104. doi: 10.3748/wjg.v25.i34.5097.
• Background Kuo CH, Lu CY, Shih HY, Liu CJ, Wu MC, Hu HM, Hsu WH, Yu FJ, Wu DC, Kuo FC. CYP2C19 polymorphism influences Helicobacter pylori eradication. World J Gastroenterol. 2014 Nov 21;20(43):16029-36. doi: 10.3748/wjg.v20.i43.16029.
• Background Fallone CA, Chiba N, van Zanten SV, Fischbach L, Gisbert JP, Hunt RH, Jones NL, Render C, Leontiadis GI, Moayyedi P, Marshall JK. The Toronto Consensus for the Treatment of Helicobacter pylori Infection in Adults. Gastroenterology. 2016 Jul;151(1):51-69.e14. doi: 10.1053/j.gastro.2016.04.006. Epub 2016 Apr 19.
• Background Arenas A, Serrano C, Quinones L, Harris P, Sandoval M, Lavanderos M, Sepulveda R, Maquilon S, Echeverria A, Rios C, Fuentes-Lopez E, Rojas L, Jorquera A, Pizarro M, Camargo MC, Riquelme A. High prevalence of clarithromycin resistance and effect on Helicobacter pylori eradication in a population from Santiago, Chile: cohort study and meta-analysis. Sci Rep. 2019 Dec 27;9(1):20070. doi: 10.1038/s41598-019-56399-7.
• Background Gonzalez-Hormazabal P, Arenas A, Serrano C, Pizarro M, Fuentes-Lopez E, Arnold J, Berger Z, Musleh M, Valladares H, Lanzarini E, Jara L, Castro VG, Camargo MC, Riquelme A. Prevalence of Helicobacter pylori Antimicrobial Resistance Among Chilean Patients. Arch Med Res. 2021 Jul;52(5):529-534. doi: 10.1016/j.arcmed.2021.01.011. Epub 2021 Feb 12.
• Background Camargo MC, Garcia A, Riquelme A, Otero W, Camargo CA, Hernandez-Garcia T, Candia R, Bruce MG, Rabkin CS. The problem of Helicobacter pylori resistance to antibiotics: a systematic review in Latin America. Am J Gastroenterol. 2014 Apr;109(4):485-95. doi: 10.1038/ajg.2014.24. Epub 2014 Mar 4.
• Background Reyes D, Ortiz J, Fuentes-Lopez E, Budnik S, Gandara V, Gallardo A, Seydewitz MF, Candia R, Vargas JI, Rollan MP, Godoy J, Rollan A, Mansilla R, Arenas A, Chahuan J, Espino A, Pizarro M, Riquelme A. Quadruple therapies are superior to standard triple therapy for Helicobacter pylori first-line eradication in Chile. Gastroenterol Hepatol. 2022 Aug-Sep;45(7):515-523. doi: 10.1016/j.gastrohep.2021.11.010. Epub 2021 Dec 7. English, Spanish.
• Background Kita T, Tanigawara Y, Aoyama N, Hohda T, Saijoh Y, Komada F, Sakaeda T, Okumura K, Sakai T, Kasuga M. CYP2C19 genotype related effect of omeprazole on intragastric pH and antimicrobial stability. Pharm Res. 2001 May;18(5):615-21. doi: 10.1023/a:1011025125163.
• Background Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich). 2008 May;10(5):348-54. doi: 10.1111/j.1751-7176.2008.07572.x.
• Background Valencia-Monsalvez F, Mendoza-Parra S, Luengo-Machuca L. [Evaluation of Morisky medication adherence scale (mmas-8) in older adults of a primary health care center in Chile]. Rev Peru Med Exp Salud Publica. 2017 Apr-Jun;34(2):245-249. doi: 10.17843/rpmesp.2017.342.2206. Spanish.
• Medel-Jara PA, Latorre G, Fuentes-Lopez E, Pizarro M, Viviani P, Chahuan J, Maquilon S, Corsi O, Reyes D, Espino A, Vargas JI, Wichmann IA, Harris P, Serrano C, Buruato I, Sandoval C, Varela NM, Cerpa L, Quinones L, Megraud F, Huang RJ, Shah SC, Perez AR. Comparison between optimized bismuth quadruple therapy and standard clarithromycin-based triple therapy for first-line Helicobacter pylori eradication: a double-blind randomized controlled trial. Lancet Reg Health Am. 2025 Nov 22;53:101312. doi: 10.1016/j.lana.2025.101312. eCollection 2026 Jan.

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