Vonoprazan for Helicobacter Pylori Eradication in Adolescents

• Status: Recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

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 determine if it offers superior eradication rates (VONTAPE trial).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alexandria University
• Treatments: Amoxicillin; Clarithromycin; Esomeprazole

Criteria

Inclusion Criteria:

1. Children in the age group (10-18 years), both genders, referred with dyspeptic complaints such as heartburn, dyspepsia, nausea, and epigastric pain.

2. Who is positive for H. Pylori infection by a standardized diagnostic test.

3. 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 Criteria:

1. allergy to any of the drugs used in the study

2. previous attempts to eradicate H.P.

3. Use of antibiotics, acid-suppression, bismuth, or probiotics 4 weeks before enrollment.

4. Children with conditions that affect medication absorption e.g. celiac or Crohn's disease.

5. Liver or kidney failure.

6. symptoms suggestive of functional disorders.