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Xylitol for the Prevention of Acute Otitis Media Episodes in Children

NCT03055091 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 472

Last updated 2019-09-06

No results posted yet for this study

Summary

This is a randomized controlled trial of regular daily use of xylitol (or "birch sugar"), a natural sweetener that has antimicrobial properties, for the prevention of acute otitis media (AOM, primary outcome) as well as upper respiratory tract infections and dental caries (the two secondary outcomes) in preschool aged children. This trial will be conducted through the TARGet Kids! research network.

Conditions

  • Acute Otitis Media
  • URTI
  • Dental Caries in Children

Interventions

OTHER

Xylitol syrup

Each dose will be 5 mL of 400 g/L and subjects will receive Three to 5 doses will be given each day.

OTHER

Placebo

Each dose looks and tastes like the xylitol syrup but it is not microbial. Each dose will be 5 mL of 300 g/L of sorbitol. Three to 5 doses will be given each day.

Sponsors & Collaborators

  • The Hospital for Sick Children

    collaborator OTHER

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Nav Persaud, MD · Unity Health Toronto

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-31
Primary Completion
2021-06-30
Completion
2021-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03055091 on ClinicalTrials.gov