Interventional Recruiting Phase 4
NCT06143124 on ClinicalTrials.gov
Bismuth Quadruple Therapy Versus Standard Triple Therapy
Official title: Bismuth Quadruple Therapy Versus Standard Triple Therapy for the First-line Treatment of Helicobacter Pylori Infection in Children: Efficacy and Safety
- Sponsor: Ljubljana University Medical Centre
- Enrollment: 216 (Estimated)
- Study start: 2022-03-03 (Actual)
- Primary completion: 2025-11-03 (Estimated)
- Study completion: 2025-11-03 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- InterventionModelDescription: one group (control) the classical eradication treatment therapy (14 days), second group (therapeutic) shorter duration of therapy (7 days) with the same drugs including Bismuth
- Masking: None
- PrimaryPurpose: Treatment
Brief Summary
The goal of this clinical trial is to compare the standard triple therapy with Bismuth quadruple therapy in children infected with Helicobacter pylori.
The main questions to answer are:
* the safety
* the efficacy of the quadruple protocol with Bismuth subcitrate
Participants will be randomised in 7-days eradication therapy group and 14-days eradication control group.
Conditions
- Helicobacter Pylori Infection
Intervention / Treatment
- Drug: Bismuth Subcitrate
Primary Outcome Measures
-
Adverse effects of the Bismuth
(duration of treatment (7 days))
questionnaire for possible side effects
Countries
Slovenia
Locations and Investigators
-
Matjaž Homan, Ljubljana, Slovenia (Recruiting)
- Matjaž Homan, MD PhD
- Anja Praprotnik, MD
- Zrinka Misak, MD PhD
- Eva Miler Mojskrc, MD