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This study aims to evaluate the real-world effectiveness of different treatment regimens used to eradicate Helicobacter pylori (H. pylori) infection in routine clinical practice. H. pylori is a common bacterial infection that can lead to chronic gastritis, peptic ulcers, and gastric cancer. Treatment success varies widely in real-world settings due to factors such as antibiotic resistance, patient characteristics, and treatment adherence.
This retrospective observational study will review medical records of patients who underwent H. pylori testing and/or eradication treatment at Shenzhen Hospital of Southern Medical University between 2016 and 2023. No additional tests, visits, or interventions will be performed beyond standard clinical care. The study will collect information on demographics, comorbidities, treatment regimens, test results, and eradication outcomes.
The primary goal is to determine the real-world eradication success rate of commonly used treatment regimens. A secondary goal is to identify factors that may influence treatment effectiveness. Findings from this study may help clinicians choose more effective treatment strategies and improve patient outcomes in everyday clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients With Helicobacter pylori Infection | Participants who underwent H. pylori testing and/or eradication treatment at Shenzhen Hospital of Southern Medical University between 2016 and 2023. This cohort includes patients receiving different eradication regimens as part of routine clinical care. No study-assigned interventions are provided. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Study-Assigned Intervention | Other | Participants receive standard-of-care H. pylori eradication regimens as determined by their treating physicians. The study does not assign or modify any treatment. Data are collected retrospectively from routine clinical records. |
| Measure | Description | Time Frame |
|---|---|---|
| H. pylori Eradication Success Rate | The proportion of patients who achieve successful eradication of Helicobacter pylori, as confirmed by a urea breath test (C13), stool antigen test, histology, or other clinically accepted diagnostic methods. Eradication success is defined as a negative post-treatment test result. | Within 4-12 weeks after completion of eradication therapy |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of patients who underwent Helicobacter pylori (H. pylori) testing and/or eradication treatment at Shenzhen Hospital of Southern Medical University between 2016 and 2023. These patients represent a real-world clinical population receiving routine diagnostic evaluation and standard-of-care treatment for H. pylori infection. Individuals aged 14 years and older, regardless of sex, are eligible for inclusion. Patients may present with various gastrointestinal or systemic comorbidities commonly associated with H. pylori infection. No study-specific interventions are administered, and all treatments are determined by the patients' treating physicians as part of usual clinical practice.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen Hospital of Southern Medical University | Shenzhen | Guangdong | 518000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | https://rs.yiigle.com/cmaid/1435828 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 28, 2024 | Jan 21, 2026 | Prot_SAP_000.pdf |
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