Vonoprazan versus a proton pump inhibitor with vitamin D or probiotics added to triple antibiotics for H. pylori eradication
Safety and Efficacy of Vonoprazan vs Proton Pump Inhibitor With Vitamin D or Probiotics Based Triple Therapy for Eradication of Helicobacter Pylori Infection
This trial tests whether replacing a PPI with vonoprazan and adding vitamin D or a probiotic to standard clarithromycin–amoxicillin therapy helps adults with H. pylori infection clear the bacteria.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta) |
| Trial ID | NCT07293910 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial randomizes adults with confirmed H. pylori infection to receive either vonoprazan- or PPI-based triple therapy (clarithromycin plus amoxicillin) combined with either vitamin D supplementation or a probiotic. Treatment is given per protocol and H. pylori eradication is checked using stool antigen, urea breath test, or endoscopy-based testing. Patients with recent antibiotic or acid-suppressing drug use, pregnancy, significant liver or renal disease, prior eradication therapy, or known allergy to regimen components are excluded. The study is conducted at Tanta University Hospital with follow-up testing to compare eradication rates and tolerability between arms.
Who should consider this trial
Good fit: Adults aged 18 to under 80 with a confirmed H. pylori infection who are not pregnant or lactating and who have not recently used antibiotics, PPIs, or H2 blockers are the intended participants.
Not a fit: Patients with prior H. pylori eradication therapy, recent antimicrobial or acid-suppressant use, active liver or renal disease, pregnancy/lactation, or allergies to study drugs are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the regimen could raise H. pylori eradication rates and reduce treatment failures compared with conventional PPI-based triple therapy.
How similar studies have performed: Previous trials have shown vonoprazan can achieve higher eradication rates than PPIs in some settings, while evidence for added benefit from vitamin D or probiotics is mixed and less conclusive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Both male and female patients. • Patients ≥ 18 and \<80 years old. Patients with confirmed diagnosis of H. pylori infection using either stool antigen test, urea breath test or endoscopy. Exclusion Criteria: * Pregnant or lactating patients. • Patients with inflammatory diseases. • Patients sensitive to any of the regimens' components. • Patients who had received a previous eradication therapy, recent use of antimicrobial agents, proton pump inhibitors, and H2 receptor blockers within 1 month. Patients with previous incidents of gastric or duodenal bleeding, gastric surgery or gastric malignancy. • Patients with active liver disease. • Patients with renal impairment. • Concurrent use of liver enzyme inducers, inhibitors or drugs with high plasma protein binding.
Where this trial is running
Tanta
- Tanta university hospital — Tanta, Egypt (Recruiting)
Study contacts
- Study coordinator: Hagar Khaled Dewidar, Msc in Clinical Pharmacy
- Email: hagar.dewidar@pharm.tanta.edu.eg
- Phone: +201014679670
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.