P-CABs plus bismuth quadruple treatment for Helicobacter pylori infection
Official title: Efficacy and Safety of P-CABs-Based Bismuth Quadruple Therapy for First-line Helicobacter Pylori Eradication: A Multicenter Cohort Study
Run by Qilu Hospital of Shandong University · NCT07285096 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 1730 (estimated) |
| Sponsor | Qilu Hospital of Shandong University Academic / other |
| Locations | 1 site (Jinan) |
| Status | Recruiting |
| Started | December 16, 2025 |
| Main results expected | June 1, 2026 |
| Study ends | August 1, 2026 |
| Registry record updated | December 23, 2025 |
| Trial ID | NCT07285096 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
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 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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Qilu Hospital of Shandong University
Jinan, China Recruiting
Study contacts
- Study coordinator: Yueyue Li
- Email: lyynqj@126.com
- Phone: +8618560089751
Similar studies
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This project will try adding bismuth to standard antibiotic and PPI treatment to see if it helps clear H. pylori and heal ulcers in children.
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This trial tests whether a 14-day tegoprazan plus amoxicillin regimen works as well as a vonoprazan plus amoxicillin regimen to cure Helicobacter pylori infection in adults.
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This trial tests whether a potassium-competitive acid blocker works better than a proton pump inhibitor as part of bismuth quadruple therapy to cure H. pylori infection in adults.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.