Xylitol for the Prevention of Acute Otitis Media Episodes in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

472 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-31

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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This is an RCT 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. Clinical equipoise over the efficacy of xylitol in preventing AOM - a common and costly condition in early childhood - persists even after the completion of three RCTs by a single research group in Finland and one in the United States. Several clinical trials of xylitol for the prevention of dental caries and other studies have demonstrated that the intervention in this trial (3-5 doses of xylitol per day) is safe, well tolerated and feasible for the study period. This trial will be conducted through the TARGet Kids! research network which is undertaking several CIHR funded RCTs and will leverage existing CIHR funded infrastructure and important collaborations. The nominated principal applicant's salary is supported by a CIHR RCT training grant to develop this RCT under the mentorship of a co-principal applicant who is an experienced trialist. This trial has the potential to transform the management of three common conditions during early childhood from treatment to prevention using a currently underutilized antimicrobial substance.

Conditions

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Acute Otitis Media URTI Dental Caries in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Participants will be randomized to the treatment arm or control arm and will receive the study product or placebo.

Study Groups

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Treatment group

Participants in the treatment arm will receive a Xylitol syrup.

Group Type EXPERIMENTAL

Xylitol syrup

Intervention Type OTHER

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

Placebo

Participants in the placebo arm will receive sorbitol syrup.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Sorbitol syrup

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No