HELICOBACTER PYLORI INFECTIONSHp-SHARERegNCT07335406
Registry for the Management of Helicobacter Pylori Infection in Shandong Province
An observational study of HELICOBACTER PYLORI INFECTIONS, run by Yueyue Li at 2 sites in China.
Trial summary
Helicobacter pylori infection is a common global gastrointestinal infectious disease, affecting approximately 43.1% of the world's population. Eradicating H. pylori is crucial for reducing the risk of developing conditions such as gastritis, peptic ulcer disease, and gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HELICOBACTER PYLORI INFECTIONS
- What is being tested?
- Doctors prescribe Helicobacter pylori treatment regimens for patients based on current guidelines and consensus statements, tailored to individual circumstance, not involve any intervention procedure.
- How many people
- 10,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 Feb 2026to 30 Nov 2035
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: (1) patients aged 18-80 years, regardless of gender; (2) willing to receive H. pylori eradication therapy; (3) diagnosed with H. pylori infection through at least one of the following methods: rapid urease test, ¹³C/¹⁴C-urea breath test, or histopathological examination.
Who may be able to join
- patients aged 18-80 years, regardless of gender;
- willing to receive H. pylori eradication therapy;
- diagnosed with H. pylori infection through at least one of the following methods: rapid urease test, ¹³C/¹⁴C-urea breath test, or histopathological examination.
Who cannot join
- patients with incomplete medical records, including missing treatment details, absence of post-treatment follow-up test results, or failure to complete essential follow-up assessments;
- patients with severe underlying conditions such as hepatic insufficiency, renal insufficiency, or malignant tumours;
- pregnant or breastfeeding women;
- individuals who refuse to sign the informed consent form
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Yueyue Li, 18560089751, lyynqj@126.com
lyynqj@126.com
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Yueyue Li, 18560089751, lyynqj@126.com
lyynqj@126.com
About this study
Helicobacter pylori infection is a common global gastrointestinal infectious disease, affecting approximately 43.1% of the world's population. Eradicating H. pylori is crucial for reducing the risk of developing conditions such as gastritis, peptic ulcer disease, and gastric cancer. Currently, 14-day high-dose dual therapy containing amoxicillin and bismuth-containing quadruple therapy are the guideline-recommended first-line treatment regimens for H. pylori eradication. Treatment options for H. pylori vary considerably, with differing efficacy outcomes largely attributable to increasing bacterial antibiotic resistance. Furthermore, multiple factors influence the efficacy of H. pylori eradication, including smoking, body surface area, CYP2C19 gene polymorphisms, patient compliance, and regional variations.
Therefore, to systematically evaluate the efficacy and safety of different treatment regimens alongside the cost-effectiveness of various therapeutic strategies, and to conduct ongoing critical analysis of clinical practice, this study proposes a long-term investigation of real-world clinical practice through a non-interventional cohort study registry. This will assess the effectiveness, safety, and temporal trends of different H. pylori infection treatment regimens, providing real-time evidence to support clinical practice.
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Being tested
- Doctors prescribe Helicobacter pylori treatment regimens for patients based on current guidelines and consensus statements, tailored to individual circumstance, not involve any intervention procedure.
- Keywords
- Helicobacter pylori
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doctors prescribe Helicobacter pylori treatment regimens for patients based on current guidelines and consensus statements, tailored to individual circumstance, not involve any intervention procedure.Other
Doctors prescribe Helicobacter pylori treatment regimens for patients based on current guidelines and consensus statements, tailored to individual circumstance, not involve any intervention procedure.
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate
Measured: at least 6 weeks after treatment completion
Secondary outcomes (1)
Adverse events
Measured: immediately after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Feb 2026
- Primary completion1 Nov 2035 (estimated)
- Study completion30 Nov 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Yueyue Li
- Sponsor type
- University, hospital or other
- Collaborators
- Qilu Hospital of Shandong University, Feicheng People's Hospital, Binzhou Maternal and Child Health Hospital, Jinxiang County People's Hospital, The People's Hospital of Jimo, Zibo Maternal and Child Health Hospital, Yantai Penglai Traditional Chinese Medicine Hospital, Zaozhuang Municipal Hospital, Linyi People's Hospital, Taierzhuang District People's Hospital, Shandong University of Traditional Chinese Medicine, Yuncheng Traditional Chinese Medicine Hospital, Caoxian County Hospital, Qihe County People's Hospital, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Dezhou Hospital Qilu Hospital of Shandong University, Dongying No. 2 People's Hospital, Zhangdian District Hospital of Traditional Chinese Medicine, Yantai Zhifu Hospital, Inner Mongolia People's Hospital, Hohhot Second Hospital, Guanxian County People's Hospital, Longkou People's Hospital, Linshu County Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor-investigator, Yueyue Li, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335406
- Sponsor's protocol ID
- 202601
- Acronym
- Hp-SHAREReg
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry for the Management of Helicobacter Pylori Infection in Shandong Province
- ClinicalTrials.gov ID
- NCT07335406
- Acronym / sponsor ID
- Hp-SHAREReg / 202601
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Keywords
- Helicobacter pylori
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Yueyue LiUniversity, hospital or other
- Collaborators
- Qilu Hospital of Shandong University, Feicheng People's Hospital, Binzhou Maternal and Child Health Hospital, Jinxiang County People's Hospital, The People's Hospital of Jimo, Zibo Maternal and Child Health Hospital, Yantai Penglai Traditional Chinese Medicine Hospital, Zaozhuang Municipal Hospital, Linyi People's Hospital, Taierzhuang District People's Hospital, Shandong University of Traditional Chinese Medicine, Yuncheng Traditional Chinese Medicine Hospital, Caoxian County Hospital, Qihe County People's Hospital, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Dezhou Hospital Qilu Hospital of Shandong University, Dongying No. 2 People's Hospital, Zhangdian District Hospital of Traditional Chinese Medicine, Yantai Zhifu Hospital, Inner Mongolia People's Hospital, Hohhot Second Hospital, Guanxian County People's Hospital, Longkou People's Hospital, Linshu County Hospital of Traditional Chinese Medicine
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Nov 2035 (estimated)
- Study completion
- 30 Nov 2035 (estimated)
- First posted
- 13 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.
Helicobacter pylori infection is a common global gastrointestinal infectious disease, affecting approximately 43.1% of the world's population. Eradicating H. pylori is crucial for reducing the risk of developing conditions such as gastritis, peptic ulcer disease, and gastric cancer. Currently, 14-day high-dose dual therapy containing amoxicillin and bismuth-containing quadruple therapy are the guideline-recommended first-line treatment regimens for H. pylori eradication. Treatment options for H. pylori vary considerably, with differing efficacy outcomes largely attributable to increasing bacterial antibiotic resistance. Furthermore, multiple factors influence the efficacy of H. pylori eradication, including smoking, body surface area, CYP2C19 gene polymorphisms, patient compliance, and regional variations.
Therefore, to systematically evaluate the efficacy and safety of different treatment regimens alongside the cost-effectiveness of various therapeutic strategies, and to conduct ongoing critical analysis of clinical practice, this study proposes a long-term investigation of real-world clinical practice through a non-interventional cohort study registry. This will assess the effectiveness, safety, and temporal trends of different H. pylori infection treatment regimens, providing real-time evidence to support clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- (1) patients aged 18-80 years, regardless of gender; (2) willing to receive H. pylori eradication therapy; (3) diagnosed with H. pylori infection through at least one of the following methods: rapid urease test, ¹³C/¹⁴C-urea breath test, or histopathological examination.
Key inclusion criteria (3 listed)
- patients aged 18-80 years, regardless of gender;
- willing to receive H. pylori eradication therapy;
- diagnosed with H. pylori infection through at least one of the following methods: rapid urease test, ¹³C/¹⁴C-urea breath test, or histopathological examination.
Key exclusion criteria (4 listed)
- patients with incomplete medical records, including missing treatment details, absence of post-treatment follow-up test results, or failure to complete essential follow-up assessments;
- patients with severe underlying conditions such as hepatic insufficiency, renal insufficiency, or malignant tumours;
- pregnant or breastfeeding women;
- individuals who refuse to sign the informed consent form
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 |
|---|---|---|
| Doctors prescribe Helicobacter pylori treatment regimens for patients based on current guidelines and consensus statements, tailored to individual circumstance, not involve any intervention procedure.Doctors prescribe Helicobacter pylori treatment regimens for patients based on current guidelines and consensus statements, tailored to individual circumstance, not involve any intervention procedure. | Other | – |
Primary outcome
Eradication rate
Time frame: at least 6 weeks after treatment completion
1 secondary outcome
Adverse events
Time frame: immediately after treatment completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
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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.
2 sites 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 Yueyue Li at 2 sites 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 4 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: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yueyue Li (18560089751, lyynqj@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication rate (time frame: at least 6 weeks after treatment completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2026.