A RCT of Triple Therapy With Proton Pump Inhibitor vs Vonoprazan for Helicobacter Pylori Gastritis
Status:
Recruiting
Trial end date:
2021-03-31
Target enrollment:
Participant gender:
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.