Clinical trial NCT06162949: Vonoprazan for Helicobacter Pylori Eradication in Adolescents
Official title: Vonoprazan-based Triple Therapy vs. Standard Triple Therapy for Helicobacter Pylori Eradication in Adolescents: A Randomized, Double-blinded Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Treatment Effectiveness
Keywords: Helicobacter pylori
Vonoprazan
Standard triple therapy
Adolescent
Eradication rate
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 242
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Helicobacter Pylori eradication rate
timeFrame: 4 weeks after completion of treatment
Secondary outcomes:
measure: The adverse events during therapy
timeFrame: During the treatment duration, and the end of the 2 weeks treatment protocol
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: Alexandria University
name: Sameh A Lashen, MD
role: PRINCIPAL_INVESTIGATOR
References: