Acute Otitis MediaPOME-XylitolNCT03055091
Xylitol for the Prevention of Acute Otitis Media Episodes in Children
A study testing Xylitol syrup in people with Acute Otitis Media and URTI, run by Unity Health Toronto at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 4 years
- Conditions the study is for
- Acute Otitis Media, URTI, Dental Caries in Children
- What is being tested?
- Xylitol syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 472 participants
- Where
- 2 sitesCanada
- Study dates
- 31 Mar 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
St Michael's Hospital
Toronto, Ontario, M5B 1X2
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 0A4
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Otitis Media, URTI, Dental Caries in Children
- Being tested
- Xylitol syrup, Placebo
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xylitol syrupOther
Each dose will be 5 mL of 400 g/L and subjects will receive Three to 5 doses will be given each day.
PlaceboOther
Also called Sorbitol syrup
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Participants in the treatment arm will receive a Xylitol syrup. Receives: Other: Xylitol syrup |
| Placebo | Placebo comparator | Participants in the placebo arm will receive sorbitol syrup. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute otitis media episodes
Total number of physician diagnosed acute otitis media episodes
Measured: 6 months
Secondary outcomes (2)
upper respiratory tract infection episodes
Total number of parent or caregiver reported upper respiratory tract infection episodes
Measured: 6 months
dental caries
absence of dental caries by parent report
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start31 Mar 2017
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Otitis MediaStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 472 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children
- Responsible party
- Sponsor
- Investigators
- Nav Persaud, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055091
- Sponsor's protocol ID
- 16-300
- Acronym
- POME-Xylitol
- Status last verified
- Sep 2019
- First submitted
- 3 Feb 2017
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Persaud N, Azarpazhooh A, Keown-Stoneman C, Birken CS, Isaranuwatchai W, Maguire JL, Mamdani M, Allen C, Mason D, Kowal C, Jaleel M, Bazeghi F, Thorpe KE, Laupacis A, Parkin PC. Xylitol for the prevention of acute otitis media episodes in children aged 1-5 years: a randomised controlled trial. Arch Dis Child. 2024 Jan 22;109(2):121-124. doi: 10.1136/archdischild-2023-325565.
PubMed 37890960Persaud 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.
PubMed 30082349
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xylitol for the Prevention of Acute Otitis Media Episodes in Children 2-4: A Pragmatic RCT
- ClinicalTrials.gov ID
- NCT03055091
- Acronym / sponsor ID
- POME-Xylitol / 16-300
- Conditions
- Acute Otitis Media, URTI, Dental Caries in Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 472 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 16 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: Xylitol syrupParticipants in the treatment arm will receive a Xylitol syrup. |
| Placebo | Placebo comparator | Other: PlaceboParticipants in the placebo arm will receive sorbitol syrup. |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xylitol syrupEach dose will be 5 mL of 400 g/L and subjects will receive Three to 5 doses will be given each day. | Other | Treatment group |
| PlaceboAlso: Sorbitol syrupEach 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 | Placebo |
Primary outcome
acute otitis media episodes
Time frame: 6 months
Total number of physician diagnosed acute otitis media episodes
2 secondary outcomes
upper respiratory tract infection episodes
Time frame: 6 months
dental caries
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Derived from this study: PubMed 37890960Persaud N, Azarpazhooh A, Keown-Stoneman C, Birken CS, Isaranuwatchai W, Maguire JL, Mamdani M, Allen C, Mason D, Kowal C, Jaleel M, Bazeghi F, Thorpe KE, Laupacis A, Parkin PC. Xylitol for the prevention of acute otitis media episodes in children aged 1-5 years: a randomised controlled trial. Arch Dis Child. 2024 Jan 22;109(2):121-124. doi: 10.1136/archdischild-2023-325565.
- Derived from this study: PubMed 30082349Persaud 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.
- The Applied Research GroupLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nav Persaud, MD principal investigator
Unity Health Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xylitol syrup in people with Acute Otitis Media and URTI, run by Unity Health Toronto at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine Kowal, MSc (416-813-7654 ext. 309441, christine.kowal@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute otitis media episodes (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03055091, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.