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

Šterbenc, Anja (author), Vratanar, Bor (author), Miler Mojškerc, Eva (author), Homan, Matjaž (author)

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.

• Language: English
• Keywords: treatment, eradication, Helicobacter pylori, bismuth, children
• Work type: Article
• Typology: 1.01 - Original Scientific Article
• Organization: MF - Faculty of Medicine
• Publication status: Published
• Publication version: Version of Record
• Year: 2026
• Number of pages: 8 str.
• Numbering: Vol. 31, iss. 1, art. e70103
• PID: 20.500.12556/RUL-177896
• UDC: 616.3
• ISSN on article: 1523-5378
• DOI: 10.1111/hel.70103
• COBISS.SI-ID: 264152579
• Publication date in RUL: 12.01.2026

Record is a part of a journal

• Title: Helicobacter
• Shortened title: Helicobacter
• Publisher: Wiley & Sons
• ISSN: 1523-5378
• COBISS.SI-ID: 517725209

Licences

• License: CC BY 4.0, Creative Commons Attribution 4.0 International
• Link: http://creativecommons.org/licenses/by/4.0/
• Description: This is the standard Creative Commons license that gives others maximum freedom to do what they want with the work as long as they credit the author.

Projects

• Funder: ARRS - Slovenian Research Agency
• Project number: P3-0154
• Name: Metodologija za analizo podatkov v medicini