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OpenTrials
Completed

NCT Number: NCT06576882

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

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.

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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Medicine, Alexandria University.

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Vonoprazan

Drug

Participants will receive Vonoprazan 20 mg tablets twice daily before meals.

Other names: Vonacidan, Tavoniza, Vondalous, Vonaspire, Vonseca

Amoxicillin

Drug

Participants will receive Amoxicillin 50 mg/kg/day capsules or suspension [maximum daily dose: 2 g].

Other names: Emox, Ibiamox, Amoxicid

Clarithromycin

Drug

Participants will receive Clarithromycin 20 mg/kg/day tablets or suspension [maximum daily dose: 1 g].

Other names: Klacid, Klarithro, Klarimix, Infectocure

Primary outcomes

  1. H. Pylori eradication rate

    Time frame: 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 outcomes

  1. Adverse events during treatment.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

7-day Versus 14-day Vonoprazan-based Triple Therapy for Eradication of H. Pylori in Adolescents: A Randomized Controlled Trial

Acronym: VOTE-HP

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 29, 2024
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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