Trial reportArchives of disease in childhood2024
Xylitol for the prevention of acute otitis media episodes in children aged 1-5 years: a randomised controlled trial.
Trial report in Archives of disease in childhood, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03055091 (Xylitol for the Prevention of Acute Otitis Media Episodes in Children 2-4), which is not on this map. Cited by 3 papers.
What it found
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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.
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.
Xylitol for the Prevention of Acute Otitis Media Episodes in Children 2-4: A Pragmatic RCT
Who cites it
3 citing papers in PubMed, 3 citations in OpenAlex.
- Effect of probiotic lozenges on improvement in tympanometric classification within 12 weeks in children aged 3-6 years with adenoid hypertrophy and otitis media with effusion undergoing non-surgical management: a randomized controlled trial.Frontiers in cellular and infection microbiology · 2025Trial
- The Oral and Nasal Gateway Microbiomes: Salivaomics and Systemic Health at the Airway-Digestive Interface.Microorganisms · 2026Review
- In Vitro Inhibition of Pathogens by Polyols: Optical Density-Based Screening and Implications for the Oral-Systemic Axis.Microorganisms · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 3 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo investigate the regular use of xylitol, compared with sorbitol, to prevent acute otitis media (AOM), upper respiratory tract infections (URTIs) and dental caries.
designBlinded randomised controlled trial with a 6-month study period.
settingEnrolment took place at 11 primary care practices in Ontario, Canada. PATIENTS: Children aged 1-5 years who did not use xylitol or sorbitol at enrolment.
interventionsChildren were randomly assigned to use a placebo syrup with sorbitol or xylitol syrup two times per day for 6 months.
main outcome measuresPrimary outcome was the number of clinician-diagnosed AOM episodes over 6 months. Secondary outcomes were caregiver-reported URTIs and dental caries.
resultsAmong the 250 randomised children, the mean (SD) age was 38±14 months and there were 124 girls (50%). There were three clinician-diagnosed AOM episodes in the 125 placebo group participants and six in the 125 xylitol group participants (OR 2.04; 95% CI 0.43, 12.92; p=0.50). There was no difference in number of caregiver-reported URTI episodes (rate ratio (RR) 0.88; 95% CI 0.70, 1.11) between the placebo (4.2 per participant over 6 months; 95% CI 3.6, 5.0) and xylitol (3.7; 95% CI 3.2, 4.4) groups. Dental caries were reported for four participants in the placebo group and two in the xylitol group (OR 0.42; 95% CI 0.04, 3.05; p=0.42). In a post-hoc analysis of URTIs during the COVID-19 pandemic, the rate among the 59 participants receiving placebo was 2.3 per participant over 6 months (95% CI 1.8, 3.0) and for the 55 receiving xylitol, 1.3 over 6 months (95% CI 0.92, 1.82; RR 0.56; 95% CI 0.36, 0.87). The most common adverse event was diarrhoea (28% with placebo; 34% with xylitol).
conclusionsRegular use of xylitol did not prevent AOM, URTIs or dental caries in a trial with limited statistical power. A post-hoc analysis indicated that URTIs were less common with xylitol exposure during the COVID-19 pandemic, but this finding could be spurious. TRIAL REGISTRATION NUMBER: NCT03055091.
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