Registry for the Management of Helicobacter Pylori Infection in Shandong Province (Hp-SHAREReg)

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 Overview

• Status: Recruiting
• Conditions: HELICOBACTER PYLORI INFECTIONS
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Yueyue Li; Phone Number: 18560089751; Email: lyynqj@126.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Qilu Hospital of Shandong University
      • Contact: Yueyue Li; Phone Number: 18560089751; Email: lyynqj@126.com
      • Contact: Email: lyynqj@126.com
    • Jinan, Shandong, China, 250012
      • Not yet recruiting
      • Qilu Hospital of Shandong University
      • Contact: Yueyue Li; Phone Number: 18560089751; Email: lyynqj@126.com
      • Contact: Email: lyynqj@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Eradication rate	at least 6 weeks after treatment completion

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events	immediately after treatment completion

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): November 1, 2035
• Study Completion (Estimated): November 30, 2035

Study Registration Dates

• First Submitted: January 5, 2026
• First Submitted That Met QC Criteria: January 5, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Helicobacter pylori
• Other Study ID Numbers: 202601

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No