About this trial
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.
Eligibility criteria
Qualifiers
patients aged 18-80 years, regardless of gender;
willing to receive H. pylori eradication therapy;
diagnosed with H. pylori infection through at least one of the following methods: rapid urease test, ¹³C/¹⁴C-urea breath test, or histopathological examination.
Disqualifiers
patients with incomplete medical records, including missing treatment details, absence of post-treatment follow-up test results, or failure to complete essential follow-up assessments;
patients with severe underlying conditions such as hepatic insufficiency, renal insufficiency, or malignant tumours;
pregnant or breastfeeding women;
individuals who refuse to sign the informed consent form
Trial design
Treatments tested in this trial
- Doctors prescribe Helicobacter pylori treatment regimens for patients based on current guidelines and consensus statements, tailored to individual circumstance, not involve any intervention procedure.
Treatment groups
Sponsors and collaborators
Yueyue Li
Lead sponsor
Qilu Hospital of Shandong University
Sponsor institution
Qilu Hospital of Shandong University
Collaborator
Feicheng People's Hospital
Collaborator
Binzhou Maternal and Child Health Hospital
Collaborator
Jinxiang County People's Hospital
Collaborator
The People's Hospital of Jimo
Collaborator
Zibo Maternal and Child Health Hospital
Collaborator
Yantai Penglai Traditional Chinese Medicine Hospital
Collaborator
Zaozhuang Municipal Hospital
Collaborator
Linyi Yizhou Hospital
Collaborator
Taierzhuang District People's Hospital
Collaborator
Shandong University of Traditional Chinese Medicine
Collaborator
Yuncheng Traditional Chinese Medicine Hospital
Collaborator
Caoxian County Hospital
Collaborator
Qihe County People's Hospital
Collaborator
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Collaborator
Dezhou Hospital Qilu Hospital of Shandong University
Collaborator
Dongying No. 2 People's Hospital
Collaborator
Zhangdian District Hospital of Traditional Chinese Medicine
Collaborator
Yantai Zhifu Hospital
Collaborator
Inner Mongolia People's Hospital
Collaborator
Hohhot Second Hospital
Collaborator
Guanxian County People's Hospital
Collaborator
Longkou People's Hospital
Collaborator
Linshu County Hospital of Traditional Chinese Medicine
Collaborator