Comparing Susceptibility-Guided and Empiric Rescue Treatments for Helicobacter Pylori Infection A Randomized Study in Adults with Previous Treatment Failure

What this Trial Is About

Researchers are evaluating different rescue treatment methods for Helicobacter pylori infection, focusing on patients who have previously failed anti-H. pylori therapy. The study aims to compare susceptibility-guided tailored therapy SG-TT with guideline-recommended empiric therapy GR-ET to understand which approach better eradicates the infection. It also investigates treatment adherence, side effects, and factors influencing treatment success, addressing the challenge of increasing antibiotic resistance worldwide. The study randomly assigns patients to two groups. Group A receives SG-TT, which includes one of five treatment options based on antibiotic susceptibility testing, such as clarithromycin triple therapy, levofloxacin triple therapy, metronidazole triple therapy, high-dose dual therapy, or bismuth quadruple therapy, all administered for 14 days. Group B receives the guideline-recommended empiric therapy, which is bismuth quadruple therapy for 14 days. Treatment selection in Group A follows a priority order based on specific antibiotic resistance profiles. Participants will complete daily questionnaires about symptoms, medication use, and diet during treatment. Follow-up visits will assess adherence and side effects. Four to eight weeks after treatment ends, Helicobacter pylori infection status will be checked using a 13C-urea breath test. Additionally, researchers will analyze the CYP2C19 genotype of each participant. The primary outcome is the eradication rate of the infection over 3.5 years, with secondary outcomes including treatment adherence and side effect frequency.

Efficacies of Susceptibility-guided vs Empiric Therapy for Rescue Treatment of Helicobacter Pylori Infection