| Title: | 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 |
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| Authors: | ID Šterbenc, Anja (Author)
ID Vratanar, Bor (Author)
ID Miler Mojškerc, Eva (Author)
ID Homan, Matjaž (Author) |
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| Files: |  PDF - Presentation file, download (441,42 KB)
MD5: 940483CDBD68E263677062675F30C0F7
 URL - Source URL, visit https://onlinelibrary.wiley.com/doi/10.1111/hel.70103
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| Language: | English |
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| Typology: | 1.01 - Original Scientific Article |
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| Organization: |  UKC LJ - Ljubljana University Medical Centre
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| Abstract: | Background: To achieve eradication rates > 90%, the ESPGHAN/NASPGHAN guidelines for pediatric Helicobacter pylori in-fection recommend tailored antimicrobial therapy using sufficiently high doses over 10–14 days. However, prolonged treatmentoften leads to suboptimal compliance in children, which is a major contributor to reduced eradication rates. To address this, weevaluated the efficacy and safety of a shorter, 7 day triple therapy with bismuth compared with the 14 day standard triple therapywithout bismuth in H. pylori infected children.Materials and Methods: From 2020 to 2024, we carried out a randomized controlled trial involving treatment-naïve childrenand adolescents (5–18 years old) with confirmed H. pylori infection. Eligible participants were randomly allocated to receiveeither 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. Twomonths after completing therapy, treatment success was determined using either a two-step monoclonal stool antigen assay or aurea 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 tripletherapy 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 daystandard triple therapy, supporting its use as an effective and safe treatment option for pediatric H. pylori infection. |
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| Keywords: | treatment, eradication, Helicobacter pylori |
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| Publication status: | Published |
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| Publication version: | Version of Record |
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| Year of publishing: | 2026 |
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| Number of pages: | str. 1-8 |
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| Numbering: | Vol. 31, iss. 1, [article no.] e70103 |
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| PID: | 20.500.12556/DiRROS-25237  |
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| UDC: | 616.3 |
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| ISSN on article: | 1523-5378 |
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| DOI: | 10.1111/hel.70103 |
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| COBISS.SI-ID: | 264152579 |
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| Note: | Nasl. z nasl. zaslona;
Opis vira z dne 9. 1. 2026;
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| Publication date in DiRROS: | 14.01.2026 |
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| Views: | 137 |
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| Downloads: | 99 |
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