Registry for managing Helicobacter pylori infection in Shandong Province

Registry for the Management of Helicobacter Pylori Infection in Shandong Province

This registry will collect real-world information on H. pylori treatments given to adults in Shandong Province to see which approaches work best and are safest.

Quick facts

• Study type: Observational
• Enrollment: 10000 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Qilu Hospital of Shandong University (other)
• Locations: 2 sites (Jinan, Shandong and 1 other locations)
• Trial ID: NCT07335406 on ClinicalTrials.gov

What this trial studies

This is a non-interventional, multi-center patient registry collecting clinical, treatment, and follow-up data from adults with confirmed H. pylori infection treated at participating hospitals in Shandong Province. Treating physicians will prescribe guideline-recommended regimens (for example, 14-day high-dose amoxicillin dual therapy or bismuth-containing quadruple therapy) tailored to each patient, while the registry records outcomes, adverse events, and costs. The database will also capture factors that influence eradication success such as smoking status, body surface area, CYP2C19 genotypes, patient adherence, and regional antibiotic resistance patterns. Analyses will compare effectiveness, safety, and cost-effectiveness of different real-world therapeutic strategies without altering usual clinical care.

Who should consider this trial

Good fit: Adults aged 18 to 80 with confirmed H. pylori infection who are willing to receive eradication therapy and complete follow-up are eligible.

Not a fit: Patients with severe hepatic or renal insufficiency, active malignancy, pregnant or breastfeeding women, those with incomplete medical records, or those unwilling to consent or complete follow-up are not expected to benefit from or be included in the registry.

Why it matters

Potential benefit: If successful, the registry could help doctors choose more effective, safer, and cost-effective H. pylori treatments for patients in this region, potentially lowering rates of ulcers and gastric cancer over time.

How similar studies have performed: Prior randomized trials and observational registries have shown guideline-recommended regimens such as bismuth quadruple therapy and high-dose amoxicillin dual therapy can achieve high eradication rates, but effectiveness varies by region and resistance patterns.

Eligibility criteria

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

Where this trial is running

Jinan, Shandong and 1 other locations

• Qilu Hospital of Shandong University — Jinan, Shandong, China (NOT_YET_RECRUITING)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (RECRUITING)

Study contacts

• Study coordinator: Yueyue Li

Conditions: HELICOBACTER PYLORI INFECTIONS, Helicobacter pylori