Status:
COMPLETED
7 Days vs. 14 Days of Vonoprazan-based Triple Therapy for H. Pylori Eradication
Lead Sponsor:
Alexandria University
Conditions:
Helicobacter Pylori Infection
Gastritis
Eligibility:
All Genders
10-18 years
Phase:
PHASE3
Brief Summary
The study aims to test the efficacy of 7 days vs. 14 days of Vonoprazan-triple therapy in the eradication of Helicobacter Pylori infection in adolescents and young children.
Detailed Description
After being informed about the study details, all eligible participants (or their legal guardians) will give informed written consent to be involved. After a one week screening, eligible participants ...
Eligibility Criteria
Inclusion
- Participants in the age group (10-18 years), both genders, referred with dyspeptic complaints such as heartburn, dyspepsia, nausea, and epigastric pain who are positive for H. Pylori infection by a standardized diagnostic test.
- Pediatric patients with a clinical, laboratory, and endoscopic diagnosis of H.P.-positive gastritis and the other conditions necessary for H.P. eradication, according to the Maastricht V consensus report .
Exclusion
- allergy to any of the drugs used in the study
- previous attempts to eradicate H.P.
- receipt of antibiotics, PPIs, bismuth, H2 antagonists or probiotics within 4 weeks of the study.
- Children with the diagnosis of any condition that might affect the absorption of drugs such as celiac disease or Crohn's disease.
- hepatic impairment or kidney failure.
- symptoms suggestive of functional disorders.
Key Trial Info
Start Date :
June 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
326 Patients enrolled
Trial Details
Trial ID
NCT06576882
Start Date
June 30 2024
End Date
December 1 2024
Last Update
February 11 2025
Active Locations (1)
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1
Faculty of Medicine, Alexandria University.
Alexandria, Egypt