Precision therapy guided by genotypic antibiotic resistance for Helicobacter pylori eradication: A prospective, randomized controlled trial
Abstract
BACKGROUND: Helicobacter pylori (H. pylori) is a Gram-negative bacillus classified as a Group I carcinogen by the World Health Organization. However, the efficacy of eradication therapies has declined in recent years, primarily due to the increasing prevalence of antibiotic resistance. The Maastricht VI/Florence Consensus Report highlights the importance of tailoring treatment strategies to local epidemiological data and individual antimicrobial susceptibility patterns.
AIM: To investigate the efficacy of precision-guided first-line therapy for H. pylori infection using genotypic antibiotic susceptibility testing (G-AST).
METHODS: This single-center randomized controlled trial enrolled 194 H. pylori-positive patients at a tertiary hospital in Qingdao, China (October 2022-August 2024). Participants were randomized to receive either a 14-day bismuth quadruple therapy (BQT: Amoxicillin, clarithromycin, esomeprazole, and bismuth) or a 14-day G-AST-guided regimen with tailored antibiotics (clarithromycin, levofloxacin, or tetracycline). Treatment efficacy and adverse events were compared between groups using intention-to-treat (ITT) and per-protocol (PP) analyses. Primary and secondary outcomes were analyzed with χ² tests.
RESULTS: Of 194 patients enrolled, 180 (92.8%) completed the study as planned. In the ITT analysis, the eradication rate was higher in the G-AST group than in the BQT group [92.8% (95%CI: 85.8-96.5) vs 79.4% (95%CI: 70.3-86.2), P = 0.007], with a risk…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 194 participants or records.
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