Adolescents, Gastritis, Helicobacter Pylori Infection, Vonoprazan
Conditions
Keywords
Helicobacter pylori, Vonoprazan, Triple therapy, Adolescent, Eradication rate, Children
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.
Interventions
DRUGVonoprazan
Participants will receive Vonoprazan 20 mg tablets twice daily before meals.
DRUGAmoxicillin
Participants will receive Amoxicillin 50 mg/kg/day capsules or suspension \[maximum daily dose: 2 g\].
DRUGClarithromycin
Participants will receive Clarithromycin 20 mg/kg/day tablets or suspension \[maximum daily dose: 1 g\].
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
1:1 assignment.
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed