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Vonoprazan vs Proton Pump Inhibitor With Vitamin D or Probiotics Based Triple Therapy for Eradication of Helicobacter Pylori Infection

RecruitingPhase 2Ages 18 Years - 80 YearsAllTanta University
NCT07293910 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Helicobacter pylori is a Gram-negative, spiral-shaped bacterium that infects up to 50% of the world's population, residing in the gastric mucosa and using the mucus layer for protection from the stomach's high acidity. Its clinical significance is profound: it is classified as a Group 1 carcinogen by the World Health Organization and is a primary cause of chronic gastritis, peptic ulcers, gastric lymphoma, and gastric carcinoma. The current first-line treatment, a PPI-based triple therapy (PPI + clarithromycin + amoxicillin), is experiencing a decline in efficacy (cure rates of 50-70%) due to widespread antibiotic resistance and compliance issues. To overcome this, newer agents like Vonoprazan Fumarate, a Potassium-Competitive Acid Blocker (P-CAB), are being adopted. Vonoprazan works by reversibly inhibiting the H+, K+ ATPase pump achieving stronger and longer-lasting acid suppression th

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📋 Eligibility rules (as published)
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.
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What it tests

  • Vonoparazan
  • Vitamin D
  • Probiotic
  • Amoxicillin
  • Clarithromycin 500 mg
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Where

1 site
National liver institute - Menoufia university - egypt
Shibīn al Kawm, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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