ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03055091
Recruitment Status : Recruiting
First Posted : February 16, 2017
Last Update Posted : June 20, 2018
Sponsor:
Collaborator:
The Hospital for Sick Children
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

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.

Condition or disease Intervention/treatment Phase
Acute Otitis Media URTI Dental Caries in Children Other: Xylitol syrup Other: Placebo Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 472 participants
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
Official Title: Xylitol for the Prevention of Acute Otitis Media Episodes in Children 2-4: A Pragmatic RCT
Actual Study Start Date : March 31, 2017
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine


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 Name: Sorbitol syrup




Primary Outcome Measures :
  1. acute otitis media episodes [ Time Frame: 6 months ]
    Total number of physician diagnosed acute otitis media episodes


Secondary Outcome Measures :
  1. upper respiratory tract infection episodes [ Time Frame: 6 months ]
    Total number of parent or caregiver reported upper respiratory tract infection episodes

  2. dental caries [ Time Frame: 6 months ]
    absence of dental caries by parent report


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055091


Contacts
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

Locations
Canada, Ontario
St Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1X2
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 0A4
Sponsors and Collaborators
St. Michael's Hospital, Toronto
The Hospital for Sick Children
Investigators
Principal Investigator: Nav Persaud, MD St. Michael's Hospital, Toronto

Additional Information:
Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT03055091     History of Changes
Other Study ID Numbers: 16-300
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Stomatognathic Diseases
Sorbitol
Cathartics
Gastrointestinal Agents