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

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ClinicalTrials.gov Identifier: NCT03055091
Recruitment Status : Recruiting
First Posted : February 16, 2017
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
The Hospital for Sick Children
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Tracking Information
First Submitted Date  ICMJE February 3, 2017
First Posted Date  ICMJE February 16, 2017
Last Update Posted Date September 6, 2019
Actual Study Start Date  ICMJE March 31, 2017
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2018)
acute otitis media episodes [ Time Frame: 6 months ]
Total number of physician diagnosed acute otitis media episodes
Original Primary Outcome Measures  ICMJE
 (submitted: February 13, 2017)
AOM episodes [ Time Frame: Up to 6 months ]
Total number of physician diagnosed AOM episodes
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2018)
  • upper respiratory tract infection episodes [ Time Frame: 6 months ]
    Total number of parent or caregiver reported upper respiratory tract infection episodes
  • dental caries [ Time Frame: 6 months ]
    absence of dental caries by parent report
Original Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2017)
URTI episodes and dental caries [ Time Frame: Up to 6 months ]
Total number of parent/caregiver reported Upper Respiratory Tract Infection (URTI) episodes or absence of dental caries by parent report.
Current Other Pre-specified Outcome Measures
 (submitted: June 18, 2018)
costs to parents including costs associated with attending medical appointments related to acute otitis media and lost productivity [ Time Frame: 6 months ]
the costs of attending medical appointment will include the cost of transportation and the mode of transportation will be asked during a monthly call
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Xylitol for the Prevention of Acute Otitis Media Episodes in Children
Official Title  ICMJE Xylitol for the Prevention of Acute Otitis Media Episodes in Children 2-4: A Pragmatic RCT
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Participants will be randomized to the treatment arm or control arm and will receive the study product or placebo.
Primary Purpose: Prevention
Condition  ICMJE
  • Acute Otitis Media
  • URTI
  • Dental Caries in Children
Intervention  ICMJE
  • 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.
    Other Name: Sorbitol syrup
Study Arms  ICMJE
  • Experimental: Treatment group
    Participants in the treatment arm will receive a Xylitol syrup.
    Intervention: Other: Xylitol syrup
  • Placebo Comparator: Placebo
    Participants in the placebo arm will receive sorbitol syrup.
    Intervention: Other: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 13, 2017)
472
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 4 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christine Kowal, MSc 416-813-7654 ext 309441 christine.kowal@sickkids.ca
Contact: Dalah Mason, MPH 416-813-7654 ext 302129 dalah.mason@sickkids.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03055091
Other Study ID Numbers  ICMJE 16-300
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party St. Michael's Hospital, Toronto
Study Sponsor  ICMJE St. Michael's Hospital, Toronto
Collaborators  ICMJE The Hospital for Sick Children
Investigators  ICMJE
Principal Investigator: Nav Persaud, MD St. Michael's Hospital, Toronto
PRS Account St. Michael's Hospital, Toronto
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP