Status:
COMPLETED
Vonoprazan for Helicobacter Pylori Eradication in Adolescents
Lead Sponsor:
Alexandria University
Conditions:
Treatment Effectiveness
Eligibility:
All Genders
10-18 years
Phase:
PHASE3
Brief Summary
The trial tends to evaluate the efficacy of vonoprazan-based triple therapy in eradicating H. Pylori infection in adolescent patients in Egypt, in comparison to standard treatment regimens to determin...
Detailed Description
The VONTAPE trial will compare two treatment regimens for Helicobacter pylori eradication among adolescent patients presented to the gastroenterology department in an Egyptian institute. the eligible ...
Eligibility Criteria
Inclusion
- Children in the age group (10-18 years), both genders, referred with dyspeptic complaints such as heartburn, dyspepsia, nausea, and epigastric pain.
- Who is 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.
- Use of antibiotics, acid-suppression, bismuth, or probiotics 4 weeks before enrollment.
- Children with conditions that affect medication absorption e.g. celiac or Crohn's disease.
- Liver or kidney failure.
- symptoms suggestive of functional disorders.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2024
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT06162949
Start Date
January 1 2024
End Date
August 1 2024
Last Update
August 28 2024
Active Locations (1)
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1
Faculty of Medicine
Alexandria, Egypt, 21521