HELICOBACTER PYLORI INFECTIONSNCT07374822
Real-World Study of Helicobacter Pylori Eradication Success and Its Determinants
An observational study of HELICOBACTER PYLORI INFECTIONS, run by Run-hua Li at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- HELICOBACTER PYLORI INFECTIONS
- What is being tested?
- No Study-Assigned Intervention
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 31 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Children younger than 14 years old.
- Pregnant or breastfeeding women.
- Patients deemed unsuitable for participation by the investigator based on clinical judgment.
Trial locations and contacts
1 site in 1 country.
China1 site
Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong, 518000
About this study
Official title: 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.
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Being tested
- No Study-Assigned Intervention
- Keywords
- Helicobacter pylori, H. pylori eradication, Real-world study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Study-Assigned InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No Study-Assigned Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 4-12 weeks after completion of eradication therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start1 May 2024
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HELICOBACTER PYLORI INFECTIONSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Run-hua Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Run-hua Li, Shenzhen Hospital of Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374822
- Sponsor's protocol ID
- NYSZYYEC2024K049R002
- Status last verified
- May 2024
- First submitted
- 21 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
https://rs.yiigle.com/cmaid/1435828
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Real-World Eradication Success Rate of Helicobacter Pylori Infection and Its Influencing Factors
- ClinicalTrials.gov ID
- NCT07374822
- Acronym / sponsor ID
- NYSZYYEC2024K049R002
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Keywords
- Helicobacter pylori, H. pylori eradication, Real-world study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Run-hua LiUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With Helicobacter pylori Infection | – | Other: No Study-Assigned InterventionParticipants 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. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Children younger than 14 years old.
- Pregnant or breastfeeding women.
- Patients deemed unsuitable for participation by the investigator based on clinical judgment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Study-Assigned InterventionParticipants 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. | Other | Patients With Helicobacter pylori Infection |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Backgroundhttps://rs.yiigle.com/cmaid/1435828
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HELICOBACTER PYLORI INFECTIONS, run by Run-hua Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
H. pylori Eradication Success Rate (time frame: Within 4-12 weeks after completion of eradication therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07374822, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.