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

NCT07374822 | Completed

• 1 other identifier: NYSZYYEC2024K049R002
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HELICOBACTER PYLORI INFECTIONS

Keywords

Helicobacter pylori; H. pylori eradication; Real-world study

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Other: No Study-Assigned Intervention

Interventions

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.

Patients With Helicobacter pylori Infection

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Run-hua Li: lead

Study Sites (1)

Shenzhen Hospital of Southern Medical University

Shenzhen, Guangdong, 518000, China

Location

Related Publications (1)

• https://rs.yiigle.com/cmaid/1435828

  BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Physician and Principal Research Investigator

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 29, 2026
• Study Start: May 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: January 29, 2026

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)