Vonoprazan for Helicobacter Pylori Eradication in Adolescents

Treatment Effectiveness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06162949
• Other study ID #: 0306381
• Status: Recruiting
• Phase: Phase 3
• Start date: January 1, 2024
• Est. completion date: July 1, 2024

Study information

• Verified date: February 2024
• Source: Alexandria University
• Contact: Sameh A Lashen, MD
• Phone: 1274117543
• Email: sameh.lashen[@]alexmed.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: July 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Treatment Effectiveness

Intervention

Drug:
• Vonoprazan
an acid suppressor therapy that inhibits the H+, K+-ATPase enzyme system in a potassium-competitive manner.
• Amoxicillin
An antibiotic of penicillins antibiotic group
• Clarithromycin
An antibiotic of macrolide group
• Esomeprazole
An acid suppressor therapy that blocks the proton pump.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Helicobacter Pylori eradication rate	Number of patients who will test negative for H. pylori after treatment completion.	4 weeks after completion of treatment
Secondary	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