Study on the Real-World Eradication Success Rate of Helicobacter Pylori Infection and Its Influencing Factors
Conditions: HELICOBACTER PYLORI INFECTIONS
Sponsor: Run-hua Li

STUDY PROTOCOL AND 
STATISTICAL ANALYSIS PLAN 
(SAP) 
Official Title: Real-World Effectiveness of Helicobacter pylori Eradication Regimens 
in a Single-Center Retrospective Observational Study  
NCT Number: [To be assigned]  
Document Date: 2024.05.28  
Sponsor: Shenzhen Hospital of Southern Medical University 
1. Background and Rationale
Helicobacter pylori (H. pylori) infection is highly prevalent in China and is associated 
with chronic gastritis, peptic ulcer disease, gastric mucosa–associated lymphoid tissue 
lymphoma, and gastric cancer. Increasing antibiotic resistance has reduced eradication 
success rates in real-world clinical practice. 
Shenzhen Hospital of Southern Medical University manages more than 5,000 H. 
pylori tests and over 2,000 eradication treatments annually. Despite standardized 
training, eradication success rates remain suboptimal (<80% in internal data). 
This study aims to evaluate the real-world effectiveness of commonly used 
eradication regimens and identify factors associated with treatment outcomes. 
2. Study Objectives
2.1 Primary Objective 
To determine the real-world eradication success rate of different H. pylori eradication 
regimens. 
2.2 Secondary Objectives 
•
To identify demographic, clinical, and treatment-related factors associated
with eradication success or failure.

• 
To compare the effectiveness of commonly used eradication regimens in 
routine clinical practice. 
3. Study Design 
This is a single-center, retrospective, observational study using routinely collected 
clinical data from Shenzhen Hospital of Southern Medical University. 
• 
Study Period: 2016–2023 
• 
Study Type: Observational 
• 
Time Perspective: Retrospective 
• 
Sampling Method: Non-probability, consecutive sampling 
• 
Intervention: None (standard-of-care only) 
No study-driven treatment or randomization will occur. All treatments are determined 
by treating physicians as part of routine care. 
4. Study Population 
4.1 Target Population 
Patients who underwent H. pylori testing and/or eradication treatment at Shenzhen 
Hospital of Southern Medical University between 2016 and 2023. 
4.2 Inclusion Criteria 
• 
Age ≥ 14 years 
• 
Underwent H. pylori testing and/or eradication treatment during the study 
period 
• 
Diagnosis of H. pylori infection based on national consensus guidelines or 
clinically accepted methods 
4.3 Exclusion Criteria 
• 
Age < 14 years 
• 
Pregnant or breastfeeding women 
• 
Patients deemed unsuitable by the investigator 
5. Data Sources and Data Collection 

Data will be extracted from electronic medical records (EMR), including: 
1. Demographics (age, sex) 
2. H. pylori testing method and results (C13 breath test, histology, culture, 
external hospital data) 
3. DOB values for C13 testing 
4. Comorbidities 
5. Allergy history 
6. Concomitant medications 
7. Number of eradication attempts 
8. Treatment regimen details (drug names, doses, duration, regimen 
abbreviation) 
9. Post-treatment test results 
No additional visits, tests, or procedures will be performed. 
6. Outcome Measures 
6.1 Primary Outcome 
H. pylori eradication success rate, defined as a negative post-treatment test (C13 
breath test, stool antigen, histology, or other accepted method) within 4–12 weeks 
after therapy. 
6.2 Secondary Outcomes 
• 
Factors associated with eradication success or failure 
• 
Comparison of eradication rates across regimens 
• 
Distribution of comorbidities 
• 
Number of eradication attempts before success 
7. Ethical Considerations 
This study applies for a waiver of informed consent because: 
• 
Data originate from routine clinical care 
• 
The study poses no more than minimal risk 
• 
Waiver will not adversely affect participant rights 
• 
The study cannot be practicably conducted without the waiver 
• 
Privacy and confidentiality will be strictly protected 

The protocol and waiver request will be reviewed and approved by the institutional 
ethics committee. 
8. Data Management 
• 
Data will be stored in a secure, password-protected database (Access). 
• 
Double data entry will be performed. 
• 
Source data verification will occur before database lock. 
• 
After locking, no changes will be made; corrections may be applied during 
statistical programming if necessary. 
• 
Participants will be identified only by study ID codes. 
9. Statistical Analysis Plan (SAP) 
9.1 Sample Size 
All eligible patients from 2016–2023 will be included. Estimated sample size: ~3,000 
patients. 
9.2 Statistical Methods 
Descriptive Analysis 
• 
Continuous variables: Mean ± SD 
• 
Categorical variables: counts and percentages 
Univariate Analysis 
• 
t-test for continuous variables 
• 
Chi-square test for categorical variables 
Multivariate Analysis 
• 
Multivariable logistic regression to identify independent predictors of 
eradication success 
Statistical Significance 
• 
Two-sided tests 
• 
P ≤ 0.05 considered statistically significant 
Software 

• 
SPSS 
• 
R 
10. Quality Control and Assurance 
• 
All study personnel will receive protocol and SOP training. 
• 
GCP training is required for all investigators. 
• 
Quality control personnel will verify data accuracy and protocol adherence. 
• 
Study documents will be archived after completion. 
11. Study Timeline 
• 
May 2024 – September 2024: Data extraction and cleaning 
• 
October 2024 – December 2024: Statistical analysis and report preparation 
• 
January 2025 – May 2025: Manuscript writing and academic dissemination 
12. Publication Policy 
The sponsor holds exclusive rights to study data. Publications require sponsor 
approval before submission. 
13. Human Genetic Resources 
Compliance 
Any handling of human genetic resources will comply with national regulations.