Xylitol for the Prevention of Acute Otitis Media Episodes in Children (POME-Xylitol)

Xylitol for the Prevention of Acute Otitis Media Episodes in Children 2-4: A Pragmatic RCT

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.

Study Overview

• Status: Unknown
• Conditions: Dental Caries in Children; Acute Otitis Media; URTI
• Intervention / Treatment: Other: Xylitol syrup; Other: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 472
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christine Kowal, MSc; Phone Number: 309441 416-813-7654; Email: christine.kowal@sickkids.ca
• Study Contact Backup: Name: Dalah Mason, MPH; Phone Number: 302129 416-813-7654; Email: dalah.mason@sickkids.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1X2
      • Recruiting
      • St Michael's Hospital
    • Toronto, Ontario, Canada, M5G 0A4
      • Recruiting
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Participants in the treatment arm will receive a Xylitol syrup.	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.
Placebo Comparator: Placebo; Participants in the placebo arm will receive sorbitol syrup.	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.; Other Names: Sorbitol syrup

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
acute otitis media episodes	Total number of physician diagnosed acute otitis media episodes	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
upper respiratory tract infection episodes	Total number of parent or caregiver reported upper respiratory tract infection episodes	6 months
dental caries	absence of dental caries by parent report	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
costs to parents including costs associated with attending medical appointments related to acute otitis media and lost productivity	the costs of attending medical appointment will include the cost of transportation and the mode of transportation will be asked during a monthly call	6 months

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Collaborators: The Hospital for Sick Children
• Investigators: Principal Investigator: Nav Persaud, MD, Unity Health Toronto

Publications and helpful links

General Publications

• 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.

Helpful Links

• The Applied Research Group

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2017
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: February 3, 2017
• First Submitted That Met QC Criteria: February 13, 2017
• First Posted (Actual): February 16, 2017

Study Record Updates

• Last Update Posted (Actual): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 5, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Otorhinolaryngologic Diseases; Ear Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Otitis; Otitis Media; Gastrointestinal Agents; Cathartics; Sorbitol
• Other Study ID Numbers: 16-300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No