A RCT of Triple Therapy With Proton Pump Inhibitor vs Vonoprazan for Helicobacter Pylori Gastritis

Summary

Helicobacter pylori (H. pylori) gastritis is a common bacterial infection among the elderly population. H. pylori infection causes chronic progressive gastric inflammation, peptic ulcer disease and gastric cancer. Gastric cancer is a significant contributor of cancer-related mortality. The eradication of H. pylori reduces the incidence of gastric cancer. However, the efficacy of H. pylori eradication has decreased dramatically because of antibiotic resistance. This study aims to (i) compare the eradication rates of H. pylori by triple therapy with vonoprazan for the treatment of H. pylori gastritis) (TTV regimen), with triple therapy with conventional proton pump inhibitor (PPI) (TTP regimen) in a multi-racial Asian cohort, (ii) evaluate the prevalence of antibiotic (klacid/amoxicillin/levofloxacin/tetracycline) resistance in H. pylori infected patients, and (iii) assess the safety of the TTV regimen. Diagnosed H. pylori-infected patients (n=252) will be enrolled and randomized 1:1 to TTV or TTP regimen. Gastric biopsies will be cultured and antibiotic sensitivity evaluated using E-test/agar dilution method. The safety of TTV regimen will be assessed using adverse effect questionnaire. This study may potentially impact on prescribing policies and management of H. pylori infections for improved therapeutic outcome.

Timeline

Start

2019-04-16

Primary completion

2021-03-31

Completion

2021-03-31

Publications

• Background Li M, Oshima T, Horikawa T, Tozawa K, Tomita T, Fukui H, Watari J, Miwa H. Systematic review with meta-analysis: Vonoprazan, a potent acid blocker, is superior to proton-pump inhibitors for eradication of clarithromycin-resistant strains of Helicobacter pylori. Helicobacter. 2018 Aug;23(4):e12495. doi: 10.1111/hel.12495. Epub 2018 Jun 6.
• Background Sue S, Kuwashima H, Iwata Y, Oka H, Arima I, Fukuchi T, Sanga K, Inokuchi Y, Ishii Y, Kanno M, Terada M, Amano H, Naito M, Iwase S, Okazaki H, Komatsu K, Kokawa A, Kawana I, Morimoto M, Saito T, Kunishi Y, Ikeda A, Takahashi D, Miwa H, Sasaki T, Tamura T, Kondo M, Shibata W, Maeda S. The Superiority of Vonoprazan-based First-line Triple Therapy with Clarithromycin: A Prospective Multi-center Cohort Study on Helicobacter pylori Eradication. Intern Med. 2017;56(11):1277-1285. doi: 10.2169/internalmedicine.56.7833. Epub 2017 Jun 1.

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