Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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.

More Helicobacter Pylori Infection trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment320 (estimated)
SponsorTanta University
Academic / other
Locations1 site (Tanta, El-Gharbia)
StatusRecruiting
StartedSeptember 11, 2025
Main results expectedFebruary 1, 2026
Study endsFebruary 1, 2026
Registry record updatedSeptember 12, 2025
Trial IDNCT07165444 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

  • Tanta University
    Tanta, El-Gharbia, Egypt
    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.