NCT03055091

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
472

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 16, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

March 31, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

4.3 years

First QC Date

February 3, 2017

Last Update Submit

September 5, 2019

Conditions

Acute Otitis MediaURTIDental Caries in Children

Outcome Measures

Primary Outcomes (1)

  • acute otitis media episodes

    Total number of physician diagnosed acute otitis media episodes

    6 months

Secondary Outcomes (2)

  • upper respiratory tract infection episodes

    6 months

  • dental caries

    6 months

Other Outcomes (1)

  • costs to parents including costs associated with attending medical appointments related to acute otitis media and lost productivity

    6 months

Study Arms (2)

Treatment group

EXPERIMENTAL

Participants in the treatment arm will receive a Xylitol syrup.

Other: Xylitol syrup

Placebo

PLACEBO COMPARATOR

Participants in the placebo arm will receive sorbitol syrup.

Other: Placebo

Interventions

Xylitol syrupOTHER

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

Treatment group
PlaceboOTHER

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.

Also known as: Sorbitol syrup
Placebo

Eligibility Criteria

Age2 Years - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children already enrolled in the TARGet Kids! Network, age 2 - 4 years at start of intervention, parents or care provider able to give consent, able to understand the information in English.

You may not qualify if:

  • craniofacial malformations, structural middle ear abnormalities, sibling or any other child living at the same address already enrolled in the trial, insertion of ventilation tubes prior to study period, current use of a xylitol product or reported xylitol sensitivity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St Michael's Hospital

Toronto, Ontario, M5B 1X2, Canada

RECRUITING

The Hospital for Sick Children

Toronto, Ontario, M5G 0A4, Canada

RECRUITING

Related Publications (2)

  • Persaud N, Azarpazhooh A, Keown-Stoneman C, Birken CS, Isaranuwatchai W, Maguire JL, Mamdani M, Allen C, Mason D, Kowal C, Jaleel M, Bazeghi F, Thorpe KE, Laupacis A, Parkin PC. Xylitol for the prevention of acute otitis media episodes in children aged 1-5 years: a randomised controlled trial. Arch Dis Child. 2024 Jan 22;109(2):121-124. doi: 10.1136/archdischild-2023-325565.

    PMID: 37890960DERIVED

  • Persaud N, Laupacis A, Azarpazhooh A, Birken C, Hoch JS, Isaranuwatchai W, Maguire JL, Mamdani MM, Thorpe K, Allen C, Mason D, Kowal C, Bazeghi F, Parkin P; TARGet Kids! Collaboration. Xylitol for the prevention of acute otitis media episodes in children aged 2-4 years: protocol for a pragmatic randomised controlled trial. BMJ Open. 2018 Aug 5;8(8):e020941. doi: 10.1136/bmjopen-2017-020941.

    PMID: 30082349DERIVED

Related Links

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Nav Persaud, MD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Kowal, MSc

CONTACT

416-813-7654christine.kowal@sickkids.ca

Dalah Mason, MPH

CONTACT

416-813-7654dalah.mason@sickkids.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants will be randomized to the treatment arm or control arm and will receive the study product or placebo.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This will be a pragmatic triple blind (participant and parents, practitioners and analyst will be blinded), two arm, superiority, placebo controlled randomized trial with 1:1 allocation.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2017

First Posted

February 16, 2017

Study Start

March 31, 2017

Primary Completion

June 30, 2021

Study Completion

December 31, 2021

Last Updated

September 6, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)