Registry for the Management of Helicobacter Pylori Infection in Shandong Province

NCT ID: NCT07335406

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-02-01

Study Completion Date

2035-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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HELICOBACTER PYLORI INFECTIONS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qilu Hospital of Shandong University

OTHER

Sponsor Role collaborator

Feicheng People's Hospital

UNKNOWN

Sponsor Role collaborator

Binzhou Maternal and Child Health Hospital

UNKNOWN

Sponsor Role collaborator

Jinxiang County People's Hospital

UNKNOWN

Sponsor Role collaborator

The People's Hospital of Jimo

UNKNOWN

Sponsor Role collaborator

Zibo Maternal and Child Health Hospital

UNKNOWN

Sponsor Role collaborator

Yantai Penglai Traditional Chinese Medicine Hospital

UNKNOWN

Sponsor Role collaborator

Zaozhuang Municipal Hospital

OTHER

Sponsor Role collaborator

Linyi Yizhou Hospital

UNKNOWN

Sponsor Role collaborator

Taierzhuang District People's Hospital

OTHER

Sponsor Role collaborator

Shandong University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Yuncheng Traditional Chinese Medicine Hospital

OTHER

Sponsor Role collaborator

Caoxian County Hospital

UNKNOWN

Sponsor Role collaborator

Qihe County People's Hospital

UNKNOWN

Sponsor Role collaborator

University Town Hospital, Afiliated Hospital of Shandong University of Traditional Chinese Medicine

UNKNOWN

Sponsor Role collaborator

Dezhou Hospital Qilu Hospital of Shandong University

OTHER

Sponsor Role collaborator

The 2nd People's Hospital of Dongying City

UNKNOWN

Sponsor Role collaborator

Zhangdian District Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role collaborator

Yantai Zhifu Hospital

UNKNOWN

Sponsor Role collaborator

Inner Mongolia Autonomous Region International Mongolian Medicine Hospital

UNKNOWN

Sponsor Role collaborator

Hohhot Second Hospital

UNKNOWN

Sponsor Role collaborator

Guanxian People's Hospital

UNKNOWN

Sponsor Role collaborator

Longkou People's Hospital

UNKNOWN

Sponsor Role collaborator

Linshu County Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role collaborator

Yueyue Li

OTHER

Sponsor Role lead

Responsible Party

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Yueyue Li

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status

Countries

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China

Central Contacts

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Yueyue Li

Role: CONTACT

18560089751

Facility Contacts

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Yueyue Li

Role: primary

18560089751

Role: backup

Other Identifiers

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202601

Identifier Type: -

Identifier Source: org_study_id

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