NCT07335406

Registry for the Management of Helicobacter Pylori Infection in Shandong Province

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Yueyue Li · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HELICOBACTER PYLORI INFECTIONS

Interventions

Type	Name	Description
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.	Doctors prescribe Helicobacter pylori treatment regimens for patients based on current guidelines and consensus statements, tailored to individual circumstance, not involve any intervention procedure.

Timeline

• Start date: 2026-02-01
• Primary completion: 2035-11-01
• Completion: 2035-11-30
• First posted: 2026-01-13
• Last updated: 2026-04-02

Locations

2 sites across 1 country: China