Clinical evaluation of personalized Helicobacter pylori treatment guided by PCR detection from fecal samples: a real-world study
Abstract
BACKGROUND: Growing antibiotic resistance in Helicobacter pylori (H. pylori) diminishes eradication therapy effectiveness, emphasizing the need for accurate, non-invasive diagnostic techniques. This study aims to assess the clinical utility of PCR analysis of fecal samples for detecting antibiotic resistance in guiding personalized treatment for H. pylori infection.
METHODS: A retrospective, observational study was conducted across 13 hospitals within Jiangsu Province. Fecal samples were analyzed using fluorescence PCR for the 23S rRNA and gyrA genes, indicating clarithromycin and levofloxacin resistance. Then, individualized eradication recommendations were proposed for the H. pylori-positive patients. A follow-up was performed one year later to evaluate the eradication outcomes in a routine medical environment, with participants having provided informed consent.
RESULTS: A total of 387 participants completed the eradication treatment, with an overall success rate of 91.0% (352/387, 95% CI: 87.6%-93.6%). Among them, 310 individuals received a 14-day course of bismuth quadruple therapy (BQT), achieving an eradication rate of 90.0% (279/310, 95% CI: 86.1%-93.1%). 77 participants were treated with high-dose dual therapy (HDDT) for the same duration, resulting in a slightly higher eradication rate of 94.8% (73/77, 95% CI: 87.2%-98.6%), although this difference was not statistically significant (P=0.188). No significant differences in eradication rates were observed among…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 387 participants or records.
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