Vonoprazan for Helicobacter Pylori Eradication in Adolescents: A Randomized, Controlled Trial

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

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 subjects will be randomly assigned to one of the two protocols (vonoprazan based vs. proton pump inhibitor-based triple therapy) for two weeks. then the eradication rates will be compared between the two study groups to see if there is a difference in efficacy. The currently available eradication regimens in our country show a low to intermediate eradication rate (50-75%). At the same time, H. pylori infection is prevalent. Recently, the FDA approved vonoprazan-based regimens for adult H. pylori infection with high eradication rates even in the settings of clarithromycin antibiotic resistance. In the VOTSAPE trial, we will test this efficacy in the < 18 years adolescents.

Official Title
-----------------
Vonoprazan-based Triple Therapy vs. Standard Triple Therapy for Helicobacter Pylori Eradication in Adolescents: A Randomized, Double-blinded Controlled Trial

Conditions
-----------------
Treatment Effectiveness

Intervention / Treatment
-----------------
* Drug: Vonoprazan
* Drug: Amoxicillin
* Drug: Clarithromycin
* Drug: Esomeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vonoprazan-based triple therapy<br>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 | Drug: Vonoprazan<br>* an acid suppressor therapy that inhibits the H+, K+-ATPase enzyme system in a potassium-competitive manner.<br>* Other names: Vondalous;Drug: Amoxicillin<br>* An antibiotic of penicillins antibiotic group<br>* Other names: Amoxicid;Drug: Clarithromycin<br>* An antibiotic of macrolide group<br>* Other names: Infectocure;|
| Active Comparator: Proton pump-based triple therapy standard triple therapy<br>Esomeprazole tablets [20 mg/day if < 30 kg and 40 mg/daily if ≥ 30 kg] on two divided daily doses 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 | Drug: Amoxicillin<br>* An antibiotic of penicillins antibiotic group<br>* Other names: Amoxicid;Drug: Clarithromycin<br>* An antibiotic of macrolide group<br>* Other names: Infectocure;Drug: Esomeprazole<br>* An acid suppressor therapy that blocks the proton pump.<br>* Other names: Nexicure;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helicobacter Pylori eradication rate | Number of patients who will test negative for H. pylori after treatment completion. | 4 weeks after completion of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The adverse events during therapy | Treatment-related adverse effects (TRAEs) such as abdominal discomfort, diarrhea, vomiting, nausea, flatulence, taste disturbance, or loss of appetite, the need for discontinuation of the H. pylori therapy; and/or headache. | During the treatment duration, and the end of the 2 weeks treatment protocol | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Helicobacter pylori, Vonoprazan, Standard triple therapy, Adolescent, Eradication rate