P-CABs plus bismuth quadruple treatment for Helicobacter pylori infection
Efficacy and Safety of P-CABs-Based Bismuth Quadruple Therapy for First-line Helicobacter Pylori Eradication: A Multicenter Cohort Study
Qilu Hospital of Shandong University · NCT07285096
This study tests whether using potassium-competitive acid blockers (P-CABs) in bismuth-containing quadruple therapy works better and is safe for adults with H. pylori infection.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1730 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Qilu Hospital of Shandong University (other) |
| Locations | 1 site (Jinan) |
| Trial ID | NCT07285096 on ClinicalTrials.gov |
What this trial studies
This is a multicenter observational cohort comparing real-world outcomes of different P-CAB-based bismuth quadruple regimens for H. pylori eradication. Adult patients (18–70 years) diagnosed by urease test, urea breath test, or histology received guideline-based, physician-prescribed quadruple therapy with P-CABs and bismuth, without any experimental procedures. The study collected eradication rates and adverse event incidence and examined clinical factors linked to treatment failure. Data came from Qilu Hospital of Shandong University and collaborating regional hospitals, using routine care records and follow-up testing.
Who should consider this trial
Good fit: Adults aged 18–70 with confirmed H. pylori infection who are willing to undergo eradication therapy and can complete post-treatment follow-up are the ideal candidates.
Not a fit: People under 18 or over 70, those with incomplete medical or follow-up records, or those given non‑specified (non‑quadruple) regimens are unlikely to gain information relevant to their care from this study.
Why it matters
Potential benefit: If successful, the results could identify P-CAB-containing regimens that improve eradication rates and reduce side effects for adults with H. pylori.
How similar studies have performed: Previous clinical work, especially with the P-CAB vonoprazan, has shown improved eradication in some settings, so this study builds on existing, but not yet universal, evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients aged 18-70 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 who received treatment regimens that did not comply with the quadruple regimens specified in this study.
Where this trial is running
Jinan
- Qilu Hospital of Shandong University — Jinan, China (RECRUITING)
Study contacts
- Study coordinator: Yueyue Li
- Email: lyynqj@126.com
- Phone: +8618560089751
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Helicobacter Pylori Infection, Helicobacter pylori, quadruple therapy