Vonoprazan for Helicobacter Pylori Eradication in Adolescents

Alexandria University242 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

242

Conditions

Treatment Effectiveness

Interventions

VonoprazanDRUG

an acid suppressor therapy that inhibits the H+, K+-ATPase enzyme system in a potassium-competitive manner.

AmoxicillinDRUG

An antibiotic of penicillins antibiotic group

ClarithromycinDRUG

An antibiotic of macrolide group

Eligibility

Sex: ALLMin age: 10 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Medicine

Alexandria, Egypt

Outcomes

Primary Outcomes

Helicobacter Pylori eradication rate

Number of patients who will test negative for H. pylori after treatment completion.

Time frame: 4 weeks after completion of treatment

Secondary Outcomes

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.

Time frame: During the treatment duration, and the end of the 2 weeks treatment protocol

Data from ClinicalTrials.gov

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