Bismuth Quadruple Therapy Versus Standard Triple Therapy

• Status: Recruiting
• Trial end date: 2025-11-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Centre Ljubljana
• Treatments: Bismuth; Bismuth tripotassium dicitrate

Criteria

Inclusion Criteria:

• • 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 Criteria:

• 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)