Potassium-competitive acid blocker versus proton pump inhibitor with bismuth quadruple therapy for H. pylori infection
Official title: Potassium-Competitive Acid Blocker Versus Proton Pump Inhibitor as A Part of Bismuth Based Quadruple Therapy for Treatment of Helicobacter Pylori Infection: A Randomized Controlled Trial
Run by Tanta University · NCT07165444 · Data updated 2026-11-12
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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 320 (estimated) |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El-Gharbia) |
| Status | Recruiting |
| Started | September 11, 2025 |
| Main results expected | February 1, 2026 |
| Study ends | February 1, 2026 |
| Registry record updated | September 12, 2025 |
| Trial ID | NCT07165444 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with confirmed H. pylori infection who have not previously received eradication therapy are the ideal candidates.
✕Probably not a fit
People with prior H. pylori treatment, recent antibiotic/PPI/bismuth use, pregnancy or lactation, major organ failure, prior gastric surgery, or known drug allergies are unlikely to be eligible or to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with confirmed H. pylori infection who have not had prior eradication treatment will receive bismuth-based quadruple therapy that includes either a potassium-competitive acid blocker (P-CAB) or a proton pump inhibitor (PPI) alongside bismuth, metronidazole, and tetracycline. The trial compares eradication rates using stool antigen or urea breath testing, and records safety events and patient adherence. P-CABs such as vonoprazan provide rapid and consistent acid suppression regardless of CYP2C19 genotype, which may affect treatment success. Outcomes will determine whether replacing the PPI with a P-CAB improves cure rates or tolerability.
Why it matters
Potential benefit: If successful, using a P-CAB could raise H. pylori eradication rates and improve consistency of acid suppression across patients.
How similar studies have gone: Previous trials, particularly with vonoprazan-based regimens, have shown higher eradication rates than PPI-based therapy in several settings, though results vary by region and resistance patterns.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged ≥18 years. * Both sexes. * Confirmed Helicobacter pylori infection by stool antigen (3rd-gen ELISA) or urea breath test (UBT). * No prior eradication therapy. Exclusion Criteria: * Prior Helicobacter pylori treatment. * Use of antibiotics, proton pump inhibitor, or bismuth in the prior 4 weeks. * Gastric surgery history. * Major organ failure. * Pregnancy or lactation. * Known allergy to study drugs.
Where it's running
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Tanta University
Tanta, El-Gharbia, Egypt Recruiting
Study contacts
- Study coordinator: Mohamed G Flefel, MD
- Email: mohamed.galal@med.tanta.edu.eg
- Phone: 00201009156988
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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.