Objectives: To evaluate the efficacy of colloidal bismuth subcitrate (CBS) therapy for the eradication of H. pylori in patients from a national pediatric registry of H. pylori infection.
Methods: The Spanish Registry of Children with H. pylori Infection (RENIHp) is a national, multi-center, prospective, non-interventional registry that includes children aged 5-18 years with H. pylori infection diagnosed by endoscopy. All patients in the registry who were treated with CBS between the period 2020 and 2023 were included in this study. The primary outcome was the eradication rate, which was assessed using a 13C-urea breath test or monoclonal antigen in the stool 6-8 weeks post-treatment.
Results: The registry included 682 patients, 38 (5.6%) of whom underwent treatment with CBS. Fifty percent (19/38) of patients had previously undergone unsuccessful eradication treatment. In 78.9% (30/38) of patients, treatment was guided by an antibiotic sensitivity test. In the remaining patients, an empirical approach was employed. The CBS therapies used were as follows: quadruple therapy with proton pump inhibitors (PPIs), CBS, amoxicillin, and metronidazole (MET) [18/38 (47.3%)]; quadruple therapy with PPIs, CBS, tetracycline, and MET [13/38 (34.2%)]; and other therapies [7/38 (18.4%)]. Thirty-two patients (84.2%) treated with CBS were followed-up with eradication monitoring. The overall eradication rate in patients treated with CBS was 93.8% (30/32, [95% CI: 85.4%-100%]), whereas it was 86.7% in patients in the registry who were not on CBS treatment (430/496, [95% CI: 83.3%-89.5%], p = 0.208). In the six patients with dual resistance to clarithromycin (CLA) and MET who were treated with quadruple therapy with CBS, the eradication rate was 100% (n = 6/6, [95% CI: 61.0%-100%]).
Conclusion: CBS therapies in our registry, although only used in selected cases and at lower than recommended levels, were very effective and showed an eradication rate of > 90%.
Keywords: Helicobacter pylori; bismuth; eradication therapy; pediatric.
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