Precision therapy guided by genotypic antibiotic resistance for Helicobacter pylori eradication: A prospective, randomized controlled trial
Year: 2025
Type: article
Study designs: Randomized Controlled Trial, Clinical 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 difference of 13.4% (95%CI: 3.7-23.2). In the PP analysis, eradication rates were 97.8% (95%CI: 92.4-99.4) in the G-AST group and 84.1% (95%CI: 75.1-90.3) in the BQT group (P = 0.001), with a risk difference of 13.7% (95%CI: 5.5-23.0). Adverse event incidence did not differ significantly between groups (30.9% vs 28.9%, P = 0.754). CONCLUSION G-AST-guided therapy yielded higher eradication rates than empirical BQT in first-line H. pylori treatment without increasing adverse events, supporting the clinical utility of individualized, resistance-based therapy.
Authors: Yan Xu, Jing-Wen Hao, Cong-Cong Min, Lin Yang, Cui-Ping Ma, Chao Shi, Tao Mao, Zi-Bin Tian, Tong Wang, Ya-Nan Yu
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W4416156248