Comparing vonoprazan-based dual and triple treatments with standard PPI triple therapy for H. pylori infection.
Efficacy of Vonoprazan Based Dual and Triple Therapy for Naive Patient With Helicobacter Pylori Infection
NA · Sohag University · NCT07045688
We're testing whether vonoprazan-based dual or triple treatments clear H. pylori more effectively than the usual PPI triple therapy in adults who have never been treated for the infection.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Sohag University (other) |
| Locations | 1 site (Sohag) |
| Trial ID | NCT07045688 on ClinicalTrials.gov |
What this trial studies
This single-site study enrolls adults with confirmed H. pylori infection who have not previously received H. pylori therapy. Participants are assigned to receive vonoprazan-based dual therapy, vonoprazan-based triple therapy, or a standard proton pump inhibitor (PPI)–based triple therapy for the prescribed treatment course. H. pylori eradication will be checked after treatment using histology or noninvasive tests such as stool antigen, and patients are excluded if they cannot complete therapy or follow-up. The trial is conducted at Sohag University Hospital with routine safety checks for drug allergies and adherence monitoring.
Who should consider this trial
Good fit: Adults aged over 18 with confirmed H. pylori infection who have never received H. pylori treatment and who can complete the full treatment and follow-up schedule are ideal candidates.
Not a fit: Patients who previously received H. pylori treatment, have known allergies to study medications, or cannot complete treatment or follow-up are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, vonoprazan regimens could produce higher H. pylori eradication rates than standard PPI triple therapy, lowering the risk of recurrent infection and related complications.
How similar studies have performed: Vonoprazan-based regimens have shown higher eradication rates than PPI-based therapy in other published work, so this approach has supporting evidence though regional data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: \>18 years old. * H. pylori infection: Confirmed by histopathology or non-invasive tests (e.g., stool antigen test). 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. * Patient missed follow up. * Patients refusing or neglecting test of cure for H. pylori.
Where this trial is running
Sohag
- Sohag University Hospital — Sohag, Egypt (RECRUITING)
Study contacts
- Study coordinator: Andrew K Wadea, Resident
- Email: andrewkameel511@gmail.com
- Phone: 01211498813
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.
Conditions: H. Pylori Infection