Potassium-competitive acid blocker versus proton pump inhibitor with bismuth quadruple therapy for H. pylori infection
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El-Gharbia) |
| Trial ID | NCT07165444 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18 or older with confirmed H. pylori infection who have not previously received eradication therapy are the ideal candidates.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Tanta, El-Gharbia
- Tanta University — Tanta, El-Gharbia, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohamed G Flefel, MD
- Email: mohamed.galal@med.tanta.edu.eg
- Phone: 00201009156988
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.