Introduction Xylitol (or ‘birch sugar’) is a naturally occurring sugar with antibacterial properties that has been used as a natural non-sugar sweetener in chewing gums, confectionery, toothpaste and medicines. In this preventative randomised trial, xylitol will be tested for the prevention of acute otitis media (AOM), a common and costly condition in young children. The primary outcome will be the incidence of AOM. Secondary outcomes will include upper respiratory tract infections (URTIs) and dental caries.
Methods and analysis This study will be a pragmatic, blinded (participant and parents, practitioners and analyst), two-armed superiority, placebo-controlled randomised trial with 1:1 allocation, stratified by clinical site. The trial will be conducted in the 11 primary care group practices participating in the TARGet Kids! research network in Canada. Eligible participants between the ages of 2–4 years will be randomly assigned to the intervention arm of regular xylitol syrup use or the control arm of regular sorbitol use for 6 months. We expect to recruit 236 participants, per treatment arm, to detect a 20% relative risk reduction in AOM episodes. AOM will be identified through chart review. The secondary outcomes of URTIs and dental caries will be identified through monthly phone calls with specified questions.
Ethics and dissemination Ethics approval from the Research Ethics Boards at the Hospital for Sick Children and St. Michael’s Hospital has been obtained for this study and also for the TARGet Kids! research network. Results will be submitted for publication to a peer-reviewed journal and will be discussed with decision makers.
Trial registration number NCT03055091; Pre-results.
- otitis media
- upper respiratory tract infection
- dental caries
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Contributor Co-Leads : Catherine S. Birken, Jonathon L. Maguire; Advisory Committee : RonaldCohn, Eddy Lau, Andreas Laupacis, Patricia C. Parkin, Michael Salter, PeterSzatmari, Shannon Weir; Science Review and Management Committees: Laura N. Anderson, Cornelia M. Borkhoff, Charles Keown-Stoneman , Christine Kowal, Dalah Mason ; Site Investigators : Murtala Abdurrahman,Barbara Anderson, Kelly Anderson, Gordon Arbess, Jillian Baker, Tony Barozzino,Sylvie Bergeron, Dimple Bhagat, Nicholas Blanchette, Gary Bloch, JoeyBonifacio, Ashna Bowry, Anne Brown, Jennifer Bugera, Caroline Calpin, DouglasCampbell, Sohail Cheema, Elaine Cheng, Brian Chisamore, Evelyn Constantin,Ellen Culbert, Karoon Danayan, Paul Das, Mary Beth Derocher, Anh Do, MichaelDorey, Kathleen Doukas, Anne Egger, Allison Farber, Amy Freedman, SloaneFreeman, Sharon Gazeley, Charlie Guiang, Dan Ha, Curtis Handford, LauraHanson, Leah Harrington, Hailey Hatch, Teresa Hughes, Sheila Jacobson,Lukasz Jagiello, Gwen Jansz, Mona Jasuja, Paul Kadar, Tara Kiran, HollyKnowles, Bruce Kwok, Sheila Lakhoo, MargaritaLam-Antoniades, EddyLau, Denis Leduc, Fok-Han Leung, Alan Li, Patricia Li, Jennifer Loo, JoanneLouis, Sarah Mahmoud, Jessica Malach, Roy Male, Vashti Mascoll, Aleks Meret, EliseMok, Rosemary Moodie, Julia Morinis, Maya Nader, Katherine Nash, SharonNaymark, James Owen, Jane Parry, Michael Peer, Kifi Pena, Marty Perlmutar,Navindra Persaud, Andrew Pinto, Michelle Porepa, Vikky Qi, Nasreen Ramji, NoorRamji, Jesleen Rana, Danyaal Raza, Alana Rosenthal, Katherine Rouleau, JanetSaunderson, Rahul Saxena, Vanna Schiralli, Michael Sgro, Hafiz Shuja, SusanShepherd, Barbara Smiltnieks, Cinntha Srikanthan, Carolyn Taylor, StephenTreherne, Suzanne Turner, Fatima Uddin, Meta van denHeuvel, JoanneVaughan, Thea Weisdorf, Sheila Wijayasinghe, Peter Wong, Anne Wormsbecker, JohnYaremko, Ethel Ying, Elizabeth Young, Michael Zajdman; Research Team : Farnaz Bazeghi, VincentBouchard, Marivic Bustos, Charmaine Camacho, Dharma Dalwadi, ChristineKoroshegyi, Tarandeep Malhi, Sharon Thadani, Julia Thompson, Laurie Thompson; Project Team : Mary Aglipay, ImaanBayoumi, Sarah Carsley, Katherine Cost, Karen Eny, Theresa Kim, Laura Kinlin, Jessica Omand, ShelleyVanderhout, Leigh Vanderloo; Applied Health Research Centre : Christopher Allen, Bryan Boodhoo, Olivia Chan, David W.H. Dai, JudithHall, Peter Juni, Gerald Lebovic, Karen Pope, Kevin Thorpe; Mount Sinai Services Laboratory : Rita Kandel,Michelle Rodrigues, Hilde Vandenberghe.
Contributors The following authors contributed substantially to conception and the design of the protocol: NP, AL, AA, CB, JSH, WI, JLM, MMM, KT, CA, DM, CK, FB and PP. The following authors drafted the manuscript: NP and FB. The following authors revised the manuscript critically for important intellectual content: NP, AL, AA, CB, JSH, WI, JLM, MMM, KT, CA, DM, CK, FB and PP. The following authors approved the final manuscript: NP, AL, AA, CB, JSH, WI, JLM, MMM, KT, CA, DM, CK, FB and PP. The following authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved: NP, AL, AA, CB, JSH, WI, JLM, MMM, KT, CA, DM, CK, FB and PP. Members of the TARGet Kids! contribute to data collection and provide general input on research directions.
Funding The study is funded by the Canadian Institutes of Health Research (CIHR). NP received salary support from a CIHR RCT training grant and from a PSI Graham Farquharson Knowledge Translation Fellowship. There was no role of the manufacturer in the concept, design, implementation, data collection and analysis and permission to publish. The products were purchased from the manufacturer using public research funding.
Disclaimer The agencies had no role in the design, collection, analyses or interpretation of the results of this study or in the preparation, review or approval of the manuscript.
Competing interests There are no competing interests. PP reports receiving the following grants unrelated to this study: a grant from Hospital for Sick Children Foundation during the conduct of the study; a grant from Canadian Institutes of Health Research (FRN # 115059) for an ongoing investigator initiated trial of iron deficiency in young children, for which Mead Johnson Nutrition provides non-financial support (Fer-In-Sol liquid iron supplement).
Patient consent Not required.
Ethics approval The TARGet Kids! research platform has been approved by the Research Ethics Board at the Hospital for Sick Children and St Michael’s Hospital, as well as the other affiliated sites. Ethics approval for this study has been obtained for all participating sites.
Provenance and peer review Not commissioned; externally peer reviewed.
Collaborators The TARGet Kids! Collaboration.
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