Clinical trial Recruiting at 1 site Observational Ages 18 to 80

Registry for managing Helicobacter pylori infection in Shandong Province

Official title: Registry for the Management of Helicobacter Pylori Infection in Shandong Province

Run by Qilu Hospital of Shandong University · NCT07335406 · Data updated 2026-11-12

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.

More HELICOBACTER PYLORI INFECTIONS trials

Quick facts

Study typeObservational
Ages18 Years to 80 Years
SexAll
Enrollment10000 (estimated)
SponsorQilu Hospital of Shandong University
Academic / other
Locations2 sites (Jinan, Shandong and 1 other locations)
StatusRecruiting
StartedFebruary 1, 2026
Main results expectedNovember 1, 2035
Study endsNovember 30, 2035
Registry record updatedApril 2, 2026
Trial IDNCT07335406 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • Qilu Hospital of Shandong University
    Jinan, Shandong, China
    Recruiting
  • Qilu Hospital of Shandong University
    Jinan, Shandong, China
    Not yet recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.