Clinical Evaluation of Personalized Helicobacter pylori Treatment Guided by PCR Detection from Fecal Samples: A Real-World Study

Ruolin Peng ¹ Zhimei Zhang ² Chuchu Yang ² Zhengyuan Xu ³ Jiabin Wang ³ Lei Chen ⁴ Sujun Gao ⁴ Jian Tao ⁵ Meijuan Xi ⁵ Xiaofeng Ye ⁶ Lu Shen ⁶ Qiang Zhan ⁷ Lijia Din ⁷ Jun Wang ⁸ Rong Ou ⁸ Jianhua Cui ⁹ Lin Chen ⁹ Xiaodan Xu ¹⁰ Gongyu Zhang ¹⁰ Chunyan Xu ¹¹ Jing Du ¹² Guangxia Chen ¹³ Xinxin Zhao ¹⁴ Lamei Xu ¹⁵ Min Xu ¹⁵ Zhenyu Zhang ^1*

• ¹ Department of Gastroenterology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Liaoning Province, China
• ² Department of Gastroenterology, Lianyungang Clinical College of Nanjing Medical University, Lianyungang, China
• ³ Department of Gastroenterology, The affiliated Shuyang Hospital of Xuzhou Medical University, Suqian, China
• ⁴ Department of Gastroenterology, Northern Jiangsu People's Hospital, Yang Zhou, China
• ⁵ Department of Gastroenterology, Changshu Traditional Chinese Medicine Hospital, Suzhou, Jiangsu Province, China
• ⁶ Department of Gastroenterology, Changzhou Traditional Chinese Medicine Hospital, Changzhou, Jiangsu Province, China
• ⁷ Department of Gastroenterology, The affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi, China
• ⁸ Department of Gastroenterology, Jinhu County People's Hospital, Huaian, China
• ⁹ Department of Gastroenterology, Dongtai People's Hospital, Yancheng, China
• ¹⁰ Department of Gastroenterology, Changshu No.1 People's Hospital, Suzhou, Jiangsu Province, China
• ¹¹ Department of Gastroenterology, The Affiliated Huaian Hospital of Yangzhou University, The Fifth People's Hospital of Huaian, Huaian, China
• ¹² The Affiliated Huaian Hospital of Yangzhou University, The Fifth People's Hospital of Huaian, Huaian, China
• ¹³ Department of Gastroenterology, The First People’s Hospital of Xuzhou, Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University, Xuzhou, China
• ¹⁴ The First People’s Hospital of Xuzhou, Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University, Xuzhou, China
• ¹⁵ Department of Gastroenterology, Affiliated Hospital of Jiangsu University, Zhenjiang, Jiangsu Province, China

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.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 various BQT antibiotic combinations (P=0.208). The eradication rates for HDDT, based on either vonoprazan or esomeprazole, were 96.8% (61/63, 95% CI: 89.0%-99.6%) and 85.7% (12/14, 95% CI: 57.2%-98.2% ), respectively, without a significant difference (P=0.304).PCR detection from fecal samples targeting the resistance genes of H. pylori is effective in guiding personalized treatments, highlighting its clinical utility and potential for broader application.