Registry for the Management of Helicobacter Pylori Infection in Shandong Province

Helicobacter pylori infection is a common global gastrointestinal infectious disease, affecting approximately 43.1% of the world's population. Eradicating H. pylori is crucial for reducing the risk of developing conditions such as gastritis, peptic ulcer disease, and gastric cancer. Currently, 14-day high-dose dual therapy containing amoxicillin and bismuth-containing quadruple therapy are the guideline-recommended first-line treatment regimens for H. pylori eradication. Treatment options for H. pylori vary considerably, with differing efficacy outcomes largely attributable to increasing bacterial antibiotic resistance. Furthermore, multiple factors influence the efficacy of H. pylori eradication, including smoking, body surface area, CYP2C19 gene polymorphisms, patient compliance, and regional variations. Therefore, to systematically evaluate the efficacy and safety of different treatment regimens alongside the cost-effectiveness of various therapeutic strategies, and to conduct ongoing critical analysis of clinical practice, this study proposes a long-term investigation of real-world clinical practice through a non-interventional cohort study registry. This will assess the effectiveness, safety, and temporal trends of different H. pylori infection treatment regimens, providing real-time evidence to support clinical practice.

NCT Number	NCT07335406
Lead Sponsor	Yueyue Li Collaborators: Qilu Hospital of Shandong University, Feicheng People's Hospital, Binzhou Maternal and Child Health Hospital, Jinxiang County People's Hospital, The People's Hospital of Jimo, Zibo Maternal and Child Health Hospital, Yantai Penglai Traditional Chinese Medicine Hospital, Zaozhuang Municipal Hospital, Linyi Yizhou Hospital, Taierzhuang District People's Hospital, Shandong University of Traditional Chinese Medicine, Yuncheng Traditional Chinese Medicine Hospital, Caoxian County Hospital, Qihe County People's Hospital, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Dezhou Hospital Qilu Hospital of Shandong University, Dongying No. 2 People's Hospital, Zhangdian District Hospital of Traditional Chinese Medicine, Yantai Zhifu Hospital, Inner Mongolia People's Hospital, Hohhot Second Hospital, Guanxian County People's Hospital, Longkou People's Hospital, Linshu County Hospital of Traditional Chinese Medicine
Conditions	HELICOBACTER PYLORI INFECTIONS
Enrollment	10,000 participants
Start Date	2026-02-01
Primary Completion	2035-11-01 (estimated)
Study Completion	2035-11-30 (estimated)
Updated on ClinicalTrials.gov	2026-04-02