Bismuth Quadruple Therapy Versus Standard Triple Therapy for the First-line Treatment of Helicobacter Pylori Infection in Children: Efficacy and Safety
Status: Unknown
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 18
Healthy Volunteers: f
View:
• • Male or female patients
‣ Age between 5 - 18 years with a
⁃ Minimum body weight of 15 kg
⁃ Endoscopy performed with biopsies taken for culture, histology
⁃ No previous therapy for H. pylori infection
⁃ Written informed consent
⁃ H. pylori infection confirmed by positive culture and with susceptibility testing for clarithromycin and metronidazole to allow tailored therapy
Locations
Other Locations
Slovenia
Matjaž Homan
RECRUITING
Ljubljana
Contact Information
Primary
Matjaž Homan, MD PhD
matjaz.homan@guest.arnes.si
0038640885848
Backup
Anja Praprotnik Novak, MD
anja.praprotnik.novak@kclj.si
0038615229276
Time Frame
Start Date: 2022-03-03
Completion Date: 2025-11-03
Participants
Target number of participants: 216
Treatments
Active_comparator: Therapeutic arm
Classical triple therapy according to the antibiotic susceptibility testing (two antibiotics+PPI)+ Bismuth subcitrate for 7 days
No_intervention: Control arm
Classical triple therapy according to the antibiotic susceptibility testing (two antibiotics+PPI) for 14 days
Related Therapeutic Areas
Sponsors
Leads: University Medical Centre Ljubljana