Registry for the Management of Helicobacter Pylori Infection in Shandong Province

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorYueyue Li

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

No treatment groups listed

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