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

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

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.

Study Overview

• Status: Completed
• Conditions: HELICOBACTER PYLORI INFECTIONS
• Intervention / Treatment: Other: No Study-Assigned Intervention

• Study Type: Observational
• Enrollment (Actual): 3000

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518000
      • Shenzhen Hospital of Southern Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Run-hua Li

Publications and helpful links

General Publications

• https://rs.yiigle.com/cmaid/1435828

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): May 31, 2025
• Study Completion (Actual): May 31, 2025

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: January 21, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Helicobacter pylori; H. pylori eradication; Real-world study
• Other Study ID Numbers: NYSZYYEC2024K049R002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No