Evidence map›Paper›PMID 41498301›Full record

Trial reportHelicobacter

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.

Anja Šterbenc, Bor Vratanar, Eva Miler Mojškerc, Matjaž Homan

Abstract readRandomized Controlled TrialComparative Study
In one paragraph

Trial report in Helicobacter. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Potassium-competitive acid blockers forFrontiers in cellular and infection microbiology · 2026
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Anja ŠterbencInstitute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
Bor VratanarInstitute for Biostatistics and Medical Informatics, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
Eva Miler MojškercDepartment of Pediatrics, Slovenj Gradec General Hospital, Slovenj Gradec, Slovenia.
Matjaž HomanDepartment of Gastroenterology, Hepatology, and Nutrition, University Children's Hospital, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.ORCID https://orcid.org/0000-0001-5764-5430

Funding

Javna Agencija za Raziskovalno Dejavnost RS P3-0154
6 · The paper itself

Abstract

backgroundTo 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

methodsFrom 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.

resultsSeventy-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.

conclusionsAdding 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.

Indexed as

Anti-Bacterial AgentsBismuthHelicobacter InfectionsHelicobacter pyloriAdolescentAmoxicillinChildChild, PreschoolClarithromycinDrug Therapy, CombinationFemaleHumansMaleMetronidazoleProton Pump InhibitorsTreatment OutcomeAmoxicillinAnti-Bacterial AgentsBismuthClarithromycinMetronidazoleProton Pump InhibitorsbismuthchildreneradicationHelicobacter pyloritreatment

Identifiers

PMID41498301
PMCPMC12776654

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.