Helicobacter pylori infection causes chronic gastritis, peptic ulcer disease and is involved in the development of gastric cancer. Current accepted strategies to eliminate the infection in children are a 10 days sequential treatment (proton pump inhibitor + amoxicillin 5 days followed by proton pump inhibitor + metronidazole + clarithromycin 5 days) or a triple therapy 14 days (proton pump inhibitor + amoxicillin + clarithromycin or metronidazole). However, there is a concern due to the growing resistance of Helicobacter pylori strains to antibiotics, especially clarithromycin, and the decreased efficacy of first line treatment regimens to satisfactorily eliminate the infection in children. Recent data show that combinations using bismuth salts must be considered in adults. Indeed, the efficacy of a 10 days of quadruple therapy with omeprazole plus a single three-in-one capsule containing bismuth subcitrate, metronidazole and tetracycline was shown to be highly superior to the standard triple therapy combining omeprazole, amoxicillin, and clarithromycin without related severe adverse events. The possibility of re-using bismuth salts on a more regular basis in pediatrics is being restudied through a monocentric, prospective, open label, single arm clinical trial to assess the safety and efficacy of a 10 days colloidal bismuth sub-citrate as an adjunctive therapy in combination with esomeprazole, amoxicillin and metronidazole in children aged 6-17 years, infected by Helicobacter pylori.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
colloidal bismuth sub-citrate administered as an adjunctive therapy in combination with esomeprazole, amoxicillin and metronidazole
Hôpital Universitaire Des Enfants Reine Fabiola
Brussels, Belgium
RECRUITING13C-urea breath test
Ratio of 13C/12C, expressed as delta 13C in pro mil, and compared with PeeDee Belemnite calcium carbonate standard
Time frame: Week 10
Incidence of treatment-emergent adverse event
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: Up to 10 weeks after start of study treatment
Adherence to the study treatment
Adherence reported by patient on a diary card and study drug accountability
Time frame: week 2
Intestinal microbiome analysis
Qualitative description
Time frame: Week 0
Intestinal microbiome analysis
Changes in the relative phylum-level abundance in the stools, based on 16S rRNA classification, between week 0 and week 10
Time frame: Week 10
Effect of antimicrobial resistance on the success rate
Qualitative description
Time frame: Week 10
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.