Droplet Digital PCR-Based Detection of Clarithromycin Resistance on Rapid Urease Test Samples Predicts Helicobacter pylori Eradication Success: A New Zealand Cohort Study

IF 4.3 2区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Helicobacter Pub Date : 2025-09-26 DOI:10.1111/hel.70075

Stephen James Inns, Samantha Sowerbutts, Bibek Yumnam, Kate Payne, Georgina Wheller, Mali Camberis, Thomas Mules

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Abstract

Background

Helicobacter pylori (H. pylori) infection is a major cause of peptic ulcer disease and gastric cancer. Rising clarithromycin resistance has significantly reduced the efficacy of standard triple therapy. In Aotearoa New Zealand, the prevalence and impact of antibiotic resistance remain incompletely defined, limiting the development of effective treatment strategies.

Methods and Aims

This study evaluated the feasibility and clinical utility of detecting clarithromycin resistance genes using droplet digital polymerase chain reaction (ddPCR) on stored Rapid Urease Test (RUT) samples—a relatively novel application of molecular diagnostics. We also assessed the association between resistance status and treatment outcomes following empiric first-line triple therapy. Patients with positive RUT tests during gastroscopy were treated with omeprazole-based triple therapy and followed up with H. pylori stool antigen testing to confirm eradication.

Results

Among 84 patients, clarithromycin resistance genes were detected in 13 (15.5%). Overall eradication was achieved in 74 (88.1%) patients. However, eradication success was significantly lower in those with resistance (38.5%) compared to those without (97.2%, p < 0.001). Infection burden, treatment regimen, and duration were not associated with eradication rates, supporting resistance status as the primary determinant of treatment outcome. Resistance rates were similar between Māori and Pacific patients (18.2%) and other ethnic groups (14.8%), although sample sizes limited definitive conclusions.

Conclusions

ddPCR testing on stored RUT samples is a feasible and effective method for detecting clarithromycin resistance. This study demonstrates that clarithromycin resistance, rather than infection burden, treatment regimen, or duration, drives eradication failure in New Zealand. Tailored therapy based on molecular resistance testing may enhance treatment success and support antibiotic stewardship. These findings justify the development of PCR-guided treatment pathways and provide a strong rationale for extending this approach to non-invasive stool-based testing suitable for use in primary care and screening programs.

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基于微滴数字pcr的快速脲酶检测样品克拉霉素耐药性预测幽门螺杆菌根除成功：新西兰队列研究

背景幽门螺杆菌感染是消化性溃疡和胃癌的主要原因。克拉霉素耐药性的上升显著降低了标准三联疗法的疗效。在新西兰奥特罗阿，抗生素耐药性的流行和影响仍然不完全确定，限制了有效治疗策略的发展。方法与目的本研究评价了在快速脲酶试验（RUT）样品上应用液滴数字聚合酶链反应（ddPCR）检测克拉霉素耐药基因的可行性和临床应用。我们还评估了经验性一线三联治疗后耐药状态与治疗结果之间的关系。胃镜检查中RUT检测阳性的患者接受奥美拉唑三联疗法，并随访幽门螺杆菌粪便抗原检测以确认根除。结果84例患者中检出克拉霉素耐药基因13例（15.5%）。74例（88.1%）患者实现了整体根除。然而，耐药组的根除成功率（38.5%）明显低于无耐药组（97.2%,p < 0.001）。感染负担、治疗方案和持续时间与根除率无关，支持耐药性状况是治疗结果的主要决定因素。虽然样本量限制了明确的结论，但Māori和太平洋患者（18.2%）以及其他种族患者（14.8%）的耐药率相似。结论应用ddPCR检测保存的RUT样品是检测克拉霉素耐药性的一种可行、有效的方法。这项研究表明，在新西兰，导致根除失败的原因不是感染负担、治疗方案或持续时间，而是克拉霉素耐药性。基于分子耐药检测的量身定制治疗可以提高治疗成功率并支持抗生素管理。这些发现证明了pcr引导治疗途径的发展，并为将这种方法扩展到适合用于初级保健和筛查计划的无创粪便检测提供了强有力的依据。

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来源期刊

Helicobacter 医学-微生物学

CiteScore

8.40

自引率

9.10%

发文量

审稿时长

2 months

期刊介绍： Helicobacter is edited by Professor David Y Graham. The editorial and peer review process is an independent process. Whenever there is a conflict of interest, the editor and editorial board will declare their interests and affiliations. Helicobacter recognises the critical role that has been established for Helicobacter pylori in peptic ulcer, gastric adenocarcinoma, and primary gastric lymphoma. As new helicobacter species are now regularly being discovered, Helicobacter covers the entire range of helicobacter research, increasing communication among the fields of gastroenterology; microbiology; vaccine development; laboratory animal science.