Efficacy and safety of bismuth‐based quadruple therapy forHelicobacterpylorieradication in children

• DOI: 10.1111/hel.12825
• Publication Date: 2021-06-09T08:03:14Z
• Authors: Kallirroi Kotilea; Samy Cadranel; Assaad Salame; Julie Nguyen; Tania Mahler; Véronique Yvette ...; Laurine Verset; Patrick Bontems
• Keywords: Adolescent; Helicobacter Infections; Anti-Bacterial Agents -- adverse effects; 03 medical and health sciences; Metronidazole -- adverse effects; 0302 clinical medicine; Drug Therapy; Helicobacter Infections -- drug therapy; Metronidazole; Amoxicillin -- adverse effects; bismuth; Humans; Prospective Studies; Child; Helicobacter pylori; Amoxicillin; Sciences bio-médicales et agricoles; Anti-Bacterial Agents; 3. Good health; pediatric; Treatment Outcome; Combination; Bismuth -- adverse effects; Drug Therapy, Combination; eradication therapy; Bismuth

AbstractObjectivesTo evaluate the efficacy and safety of a 10‐day quadruple therapy containing colloidal bismuth sub‐citrate (CBS), esomeprazole (ESO), amoxicillin (AMO), and metronidazole (MET) forHelicobacter pylori(H. pylori) eradication in children.MethodsMonocentric, open‐label, prospective, single‐arm clinical trial in children aged 6–17 years withH. pyloriinfection. The study was carried out on consecutive patients with upper gastrointestinal symptoms andH. pyloriinfection confirmed by histology and culture of gastric biopsies. The outcome was evaluated using a13C‐urea breath test 8–10 weeks post‐therapy. Adverse events and compliance were evaluated by daily journal and pill counting.ResultsA total of 36 children fulfilling the inclusion criteria were enrolled. Eight (22.2%) of them had a priorH. pylorieradication treatment. Thirteen (36.1%) patients were infected by a strain resistant to MET and 8 (22.2%) by a strain resistant to both MET and Clarithromycin (CLA). In the intention‐to‐treat population (ITT), eradication was achievedin35/36patients(95%CI:85%−99%). Twenty‐three children reported at least one adverse event (63.8%), mostly mild (nausea, vomiting, abdominal pain, diarrhea, dark stool, metallic taste, headache, and rash). The compliance rate was high, with 30 (83.3%) patients taking >90% of the treatment.Conclusion10‐day quadruple therapy containing CBS, ESO, AMO, and MET forH. pylorieradication in children is a safe and very effective solution, especially for previously treated patients and those infected with double resistant strains.