7 Days vs. 14 Days of Vonoprazan-based Triple Therapy for H. Pylori Eradication

Phase 3

Completed

• Conditions: Helicobacter Pylori Infection; Adolescents; Gastritis; Vonoprazan
• Interventions: Drug: Vonoprazan; Drug: Amoxicillin; Drug: Clarithromycin

• Registration Number: NCT06576882
• Lead Sponsor: Alexandria University

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 will be randomized to Vonoprazan plus Amoxicillin plus Clarithromycin triple therapy for either 14 days (group 1), or 7 days (group 2) at a 1:1 ratio. After the end of therapy, H. Pylori eradication will be evaluated after 4 weeks.

Study Timeline

• Status Verified: 2024-04
• Study Start: 2024-06-30
• Study First Submitted: 2024-08-26
• Study First Submitted QC: 2024-08-27
• Study First Posted: 2024-08-29
• Primary Completion: 2024-11-01
• Study Completion: 2024-12-01
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 326

Inclusion Criteria

1. 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.
2. 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. receipt of antibiotics, PPIs, bismuth, H2 antagonists or probiotics within 4 weeks of the study.
4. Children with the diagnosis of any condition that might affect the absorption of drugs such as celiac disease or Crohn's disease.
5. hepatic impairment or kidney failure.
6. symptoms suggestive of functional disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
14-days Vonoprazan-based triple therapy	Vonoprazan	Vonoprazan tablets 20 mg twice daily plus Amoxicillin 50 mg/kg/day capsules or suspension \[maximum daily dose 2 g\] plus Clarithromycin 20 mg/kg/day tablets or suspension \[maximum daily dose 1 g\]. The triple combination will be given for 14 days .
14-days Vonoprazan-based triple therapy	Amoxicillin	Vonoprazan tablets 20 mg twice daily plus Amoxicillin 50 mg/kg/day capsules or suspension \[maximum daily dose 2 g\] plus Clarithromycin 20 mg/kg/day tablets or suspension \[maximum daily dose 1 g\]. The triple combination will be given for 14 days .
14-days Vonoprazan-based triple therapy	Clarithromycin	Vonoprazan tablets 20 mg twice daily plus Amoxicillin 50 mg/kg/day capsules or suspension \[maximum daily dose 2 g\] plus Clarithromycin 20 mg/kg/day tablets or suspension \[maximum daily dose 1 g\]. The triple combination will be given for 14 days .
7-days Vonoprazan-based triple therapy	Vonoprazan	Vonoprazan tablets 20 mg twice daily plus Amoxicillin 50 mg/kg/day capsules or suspension \[maximum daily dose 2 g\] plus Clarithromycin 20 mg/kg/day tablets or suspension \[maximum daily dose 1 g\]. The triple combination will be given for 7 days.
7-days Vonoprazan-based triple therapy	Amoxicillin	Vonoprazan tablets 20 mg twice daily plus Amoxicillin 50 mg/kg/day capsules or suspension \[maximum daily dose 2 g\] plus Clarithromycin 20 mg/kg/day tablets or suspension \[maximum daily dose 1 g\]. The triple combination will be given for 7 days.
7-days Vonoprazan-based triple therapy	Clarithromycin	Vonoprazan tablets 20 mg twice daily plus Amoxicillin 50 mg/kg/day capsules or suspension \[maximum daily dose 2 g\] plus Clarithromycin 20 mg/kg/day tablets or suspension \[maximum daily dose 1 g\]. The triple combination will be given for 7 days.

Primary Outcome Measures

Name	Time	Method
H. Pylori eradication rate	4 weeks after completion of treatment	Number of participants who will achieve a negative H. pylori antigen detection test after the end of therapy.

Secondary Outcome Measures

Name	Time	Method
Adverse events during treatment.	From first dose of treatment until 7 or 14 days of treatment regimen assigned.	Type and frequency of treatment-related adverse effects in both arms

Trial Locations

Locations (1)

Faculty of Medicine, Alexandria University.; 🇪🇬 Alexandria, Egypt