Status:
UNKNOWN
Bismuth Quadruple Therapy Versus Standard Triple Therapy
Lead Sponsor:
University Medical Centre Ljubljana
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
5-18 years
Phase:
PHASE4
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...
Detailed Description
Infection with Helicobacter pylori (H. pylori) is still a very common bacterial infection in humans, despite the worldwide significant decrease in incidence and prevalence recorded in recent years. In...
Eligibility Criteria
Inclusion
- • 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
Exclusion
- Significant acute or chronic gastrointestinal disease (IBD, coeliac disease, GERD etc.) or other organic disease interfering with symptom assessment
- Patients with ulcers and need to be treated with PPI according to the physician judgment.
- Known allergies to used antibiotics, proton pump inhibitors or probiotics
- Having received treatment with antibiotics or bismuth compounds during the previous 30 days before endoscopy.
- Having received proton pump inhibitors during the previous two weeks.
- Severe acquired or primary immunodeficiency disorder
- Language barriers which do not allow to give informed consent and/or to adequately complete the study diary
- Being infected with a strain resistant to clarithromycin and metronidazole (double resistant)
Key Trial Info
Start Date :
March 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 3 2025
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT06143124
Start Date
March 3 2022
End Date
November 3 2025
Last Update
November 22 2023
Active Locations (1)
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1
Matjaž Homan
Ljubljana, Slovenia, 1000