20.500.12556/RUL-177896 An open-label randomized controlled trial comparing the efficacy and safety of a 7-day triple therapy with bismuth versus 14-day standard triple therapy for Helicobacter pylori eradication in children and adolescents Background: To achieve eradication rates >90%, the ESPGHAN/NASPGHAN guidelines for pediatric Helicobacter pylori infection recommend tailored antimicrobial therapy using sufficiently high doses over 10–14days. However, prolonged treatment often leads to suboptimal compliance in children, which is a major contributor to reduced eradication rates. To address this, we evaluated the efficacy and safety of a shorter, 7day triple therapy with bismuth compared with the 14day standard triple therapy without bismuth in H. pylori infected children. Materials and Methods: From 2020 to 2024, we carried out a randomized controlled trial involving treatment-naïve children and adolescents (5–18 years old) with confirmed H. pylori infection. Eligible participants were randomly allocated to receive either a 7day triple therapy with bismuth (bismuth subcitrate, a proton pump inhibitor [PPI], amoxicillin, plus clarithromycin/ metronidazole) or a 14day standard triple therapy (a PPI, amoxicillin, plus clarithromycin/metronidazole) without bismuth. Two months after completing therapy, treatment success was determined using either a two-step monoclonal stool antigen assay or a urea breath test. Any adverse events were documented using a structured questionnaire. Results: Seventy-three children were enrolled in the study. In the intention-to-treat analysis, eradication was achieved in 91% of children treated with the 7day triple therapy with bismuth and 87% of those receiving the 14day standard triple therapy (p=0.695). Per-protocol eradication rates were 94% and 87%, respectively (p=0.418). No serious adverse events were reported, and most adverse events were mild to moderate. A metallic taste was significantly more frequent in the 14day standard triple therapy group, while other adverse events occurred with similar frequency. Conclusions: Adding bismuth to a 7day triple regimen achieved high eradication rates and a safety profile similar to 14day standard triple therapy, supporting its use as an effective and safe treatment option for pediatric H. pylori infection. treatment eradication Helicobacter pylori bismuth children true false true Angleški jezik Ni določen Članek v reviji 2026-01-12 13:19:23 2026-01-12 13:19:30 2026-07-23 11:49:53 0000-00-00 00:00:00 2026 0 0 8 str. iss. 1, art. e70103 Vol. 31 2026 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 616.3 1523-5378 10.1111/hel.70103 264152579 RAZ_Sterbenc_Anja_2026.pdf RAZ_Sterbenc_Anja_2026.pdf 1 F5ACD7B646E2C8C55AC177905006AFC1 8e55fb0e371561795227e5ab58a8adddc3c8da6392ae5822fc0223d033726ea6 0b766af3-efb2-11f0-bf92-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=225308 https://onlinelibrary.wiley.com/doi/10.1111/hel.70103 0 f2c108b3-efb1-11f0-bf92-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=225307 Medicinska fakulteta 0 0 0