Vonoprazan versus a proton pump inhibitor with vitamin D or probiotics added to triple antibiotics for H. pylori eradication

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 (n=66) Patient whom are confirmed to be H-pylori negative using either stool antigen test, urea breath test or endoscopy (n=66)

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 it's running

• National liver institute - Menoufia university - egypt
  Shibīn al Kawm, Egypt Recruiting

Study contacts

• Study coordinator: Hagar Khaled Dewidar, Msc in Clinical Pharmacy
• Email: hagar.dewidar@pharm.tanta.edu.eg
• Phone: +201014679670

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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.