7 Days vs. 14 Days of Vonoprazan-based Triple Therapy for H. Pylori Eradication (VOTE-HP)

Alexandria University

Status and phase: Completed; Phase 3

Conditions: Gastritis; Adolescents; Helicobacter Pylori Infection; Vonoprazan

Treatments: Drug: Clarithromycin; Drug: Amoxicillin; Drug: Vonoprazan

Study type: Interventional

Funder types: Other

Identifiers

NCT06576882

0306630

Details and patient eligibility

About

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.

Full 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.

Enrollment: 326 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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326 participants in 2 patient groups

14-days Vonoprazan-based triple therapy

Active Comparator group

Description:

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 .

Treatment:

Drug: Amoxicillin

Drug: Vonoprazan

Drug: Clarithromycin

7-days Vonoprazan-based triple therapy

Experimental group

Description:

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 7 days.

Treatment:

Drug: Amoxicillin

Drug: Vonoprazan

Drug: Clarithromycin