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Registry for the Management of Helicobacter Pylori Infection in Shandong Province

Registry for the Management of Helicobacter Pylori Infection in Shandong Province

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07335406
Acronym
Hp-SHAREReg
Enrollment
10000
Registered
2026-01-13
Start date
2026-02-01
Completion date
2035-11-30
Last updated
2026-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HELICOBACTER PYLORI INFECTIONS

Keywords

Helicobacter pylori

Brief 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. 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.

Interventions

OTHERDoctors 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.

Sponsors

Yueyue Li
Lead SponsorOTHER
Qilu Hospital of Shandong University
CollaboratorOTHER
Feicheng People's Hospital
CollaboratorUNKNOWN
Binzhou Maternal and Child Health Hospital
CollaboratorUNKNOWN
Jinxiang County People's Hospital
CollaboratorUNKNOWN
The People's Hospital of Jimo
CollaboratorUNKNOWN
Zibo Maternal and Child Health Hospital
CollaboratorOTHER
Yantai Penglai Traditional Chinese Medicine Hospital
CollaboratorUNKNOWN
Zaozhuang Municipal Hospital
CollaboratorOTHER
Linyi Yizhou Hospital
CollaboratorUNKNOWN
Taierzhuang District People's Hospital
CollaboratorOTHER
Shandong University of Traditional Chinese Medicine
CollaboratorOTHER
Yuncheng Traditional Chinese Medicine Hospital
CollaboratorOTHER
Caoxian County Hospital
CollaboratorUNKNOWN
Qihe County People's Hospital
CollaboratorUNKNOWN
University Town Hospital, Afiliated Hospital of Shandong University of Traditional Chinese Medicine
CollaboratorUNKNOWN
Dezhou Hospital Qilu Hospital of Shandong University
CollaboratorOTHER
The 2nd People's Hospital of Dongying City
CollaboratorUNKNOWN
Zhangdian District Hospital of Traditional Chinese Medicine
CollaboratorUNKNOWN
Yantai Zhifu Hospital
CollaboratorUNKNOWN
Inner Mongolia Autonomous Region International Mongolian Medicine Hospital
CollaboratorUNKNOWN
Hohhot Second Hospital
CollaboratorUNKNOWN
Guanxian People's Hospital
CollaboratorUNKNOWN
Longkou People's Hospital
CollaboratorUNKNOWN
Linshu County Hospital of Traditional Chinese Medicine
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Eradication rateat least 6 weeks after treatment completion

Secondary

MeasureTime frame
Adverse eventsimmediately after treatment completion

Countries

China

Contacts

CONTACTYueyue Li
lyynqj@126.com18560089751

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026