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

TL;DR

A 7-day triple therapy with bismuth is as effective and safe as a 14-day standard treatment for Helicobacter pylori in children.

Contribution

Demonstrates that a shorter 7-day bismuth-based regimen achieves high eradication rates in children with H. pylori.

Findings

7-day triple therapy with bismuth achieved 91% eradication compared to 87% for 14-day standard therapy.

No serious adverse events occurred, and most were mild to moderate.

Bismuth therapy was associated with fewer metallic taste complaints than standard therapy.

Abstract

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.

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.

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.

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.

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