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Completed

NCT Number: NCT07374822

Real-World Study of Helicobacter Pylori Eradication Success and Its Determinants

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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Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shenzhen Hospital of Southern Medical University

Shenzhen, Guangdong, 518000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 14 years.
  • Patients who underwent Helicobacter pylori (H. pylori) testing and/or eradication treatment at Shenzhen Hospital of Southern Medical University between 2016 and 2023.
  • Diagnosis of H. pylori infection based on the Sixth National Consensus Report on the Management of Helicobacter pylori Infection (Non-Eradication Section) or clinically accepted testing methods.

Exclusion criteria

  • Children younger than 14 years old.
  • Pregnant or breastfeeding women.
  • Patients deemed unsuitable for participation by the investigator based on clinical judgment.

Treatment and study plan

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.

Primary outcomes

  1. H. pylori Eradication Success Rate

    Time frame: Within 4-12 weeks after completion of eradication therapy

    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.

Sponsors and collaborators

Lead sponsor

Run-hua Li

Other

Registry information

Official study title

Study on the Real-World Eradication Success Rate of Helicobacter Pylori Infection and Its Influencing Factors

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2026
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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