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

ABSTRACT Background To achieve eradication rates > 90%, the ESPGHAN/NASPGHAN guidelines for pediatric Helicobacter pylori infection recommend tailored antimicrobial therapy using sufficiently high doses over 10–14 days. 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, 7 day triple therapy with bismuth compared with the 14 day 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 7 day triple therapy with bismuth (bismuth subcitrate, a proton pump inhibitor [PPI], amoxicillin, plus clarithromycin/metronidazole) or a 14 day 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 7 day triple therapy with bismuth and 87% of those receiving the 14 day 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 14 day standard triple therapy group, while other adverse events occurred with similar frequency. Conclusions Adding bismuth to a 7 day triple regimen achieved high eradication rates and a safety profile similar to 14 day standard triple therapy, supporting its use as an effective and safe treatment option for pediatric H. pylori infection.