Proton Pump Inhibitor vs Vonoprazan Triple Therapy for H. pylori Eradication, With or Without Zinc
Official title: Comparative Study Evaluating Safety and Effectiveness of ( Proton Pump Inhibitor Versus Vonoprazan ) Based Triple Therapy With or Without Zinc to Eradicate H. Pylori Infection
Run by Tanta University · NCT07275827 · Data updated 2026-11-12
This trial tests whether a vonoprazan-based triple therapy (with or without zinc) can safely and more effectively eradicate H. pylori compared with a traditional proton-pump inhibitor-based triple therapy in adults.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 88 (estimated) |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Shibīn al Kawm) |
| Status | Recruiting |
| Started | February 1, 2026 |
| Main results expected | December 2026 |
| Study ends | February 2027 |
| Registry record updated | September 9, 2026 |
| Trial ID | NCT07275827 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with confirmed H. pylori infection by stool antigen test and no prior H. pylori treatment.
✕Probably not a fit
Patients who do not achieve eradication with the assigned regimen or who experience intolerance or adverse reactions to study medications may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 3 trial compares two regimens for treating Helicobacter pylori infection: a vonoprazan-based triple therapy and a proton pump inhibitor-based triple therapy, each combined with amoxicillin and clarithromycin, for 14 days. It also evaluates whether adding zinc to the regimen provides additional benefit. Participants are adults with confirmed H. pylori infection who have not received prior treatment for this infection. The study monitors safety and eradication success, with eradication confirmed at least four weeks after completing therapy. Location is at the National Liver Institute in Shibin El Kawm, Egypt, led by Tanta University.
Why it matters
Potential benefit: If successful, patients may experience higher eradication rates and potentially improved symptom relief with a simpler, possibly zinc-augmented regimen.
How similar studies have gone: Previous studies have shown non-inferiority or benefits of vonoprazan-based regimens in H. pylori eradication, supporting exploration in this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18. * Both males and females. * Patients who are positive for H.pylori infection by non-invasive Stool Antigen Test (SAT). Exclusion Criteria: * Prior H. pylori treatment: Previous treatment for H. pylori infection. * Allergies: Known allergies to study medications or components. * Patients cannot finish treatment course. * Pregnant and Lactating Women. * Patients with Kidney disease and eGFR \< 30ml/min. * Patients with Liver disease with Child-Pugh B or C.
Where it's running
-
National Liver Institute
Shibīn al Kawm, Egypt Recruiting
Study contacts
- Study coordinator: Eman A Mahmoud, Prof.
- Email: eabdelsameea@liver-eg.eg
- Phone: +201002415022
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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.