Registry for the Management of Helicobacter Pylori Infection in Shandong Province

Обзор

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.

Вмешательства

• Другое Doctors prescribe Helicobacter pylori treatment regimens for patients based on current guidelines and consensus statements, tailored to individual circumstance, not involve any intervention procedure.
  Doctors prescribe Helicobacter pylori treatment regimens for patients based on current guidelines and consensus statements, tailored to individual circumstance, not involve any intervention procedure.

Первичные конечные точки

• Eradication rate [Срок оценки: at least 6 weeks after treatment completion]

Вторичные конечные точки (1)

• Adverse events [Срок оценки: immediately after treatment completion]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 2 центра

• Qilu Hospital of Shandong University — Цзинань
• Qilu Hospital of Shandong University — Цзинань

Идентификаторы

NCT: NCT07335406 · 202601

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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