Xylitol for Otitis Media

Study Overview
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Brief Summary
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This is a randomized, double-blind, placebo-controlled study of children, age 6 months to 3 years, with a diagnosis of Otis media with effusion (OME) based on examination by a provider at a Duke- affiliated otolaryngology clinic.

Detailed Description
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The primary purpose of this study is to evaluate the efficacy of intranasal xylitol in young children with otitis media with effusion as measured by the resolution of middle ear effusion based on physical examination and tympanometry at 6-, 12-, and 18 and 24-weeks post-treatment. Eligible subjects will be randomly assigned to receive either intranasal xylitol spray or a nasal saline spray placebo and will be observed for 24-weeks following initiation of daily xylitol spray or placebo. The primary efficacy endpoint, the time to middle ear effusion resolution with and without the xylitol nasal spray, will be analyzed using either a two-sample t-test or non-parametric Wilcoxon test, depending on whether the time is normal or non-normal. Risks include epistaxis, diarrhea, and allergic reaction. Serious adverse events are not anticipated.

Official Title
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A Prospective, Randomized, Double-blinded, Placebo-controlled Pilot Study for Evaluating the Effectiveness of Intranasal Xylitol in Treating Otitis Media With Effusion (OME) in Children

Conditions
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Otitis Media With Effusion

Intervention / Treatment
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* Drug: Intranasal xylitol spray
* Other: Intranasal saline spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 6 months and 3 years of age. Clinical diagnosis of OME. Treated at Duke for the above condition. Ability of parent/guardian to be compliant with at-home nasal spray administration. Exclusion Criteria: History of immunodeficiency or an immunologic disorder that predisposes to frequent infections. History of prior pressure-equalization (PE) tube placement and the tubes are still in place. Active or recent (<1 month prior to screening) middle ear disease, including but not limited to: cholesteatoma, tympanic membrane perforation, congenital external or middle ear abnormalities or malformations. History of previous otologic surgery including tympanoplasty, and/or mastoidectomy. Previous use of intranasal sprays other than normal saline, including intranasal steroids, and/or xylitol within 1 month prior to screening. Any other clinically significant illness or medical condition, per PI discretion, that would prohibit the subject from participating in the study. Subject has previously been randomized to a trial of Xylitol. Parent/guardian is unable to administer the study nasal spray. Parent/guardian is unable to read, write, and understand English. Parent/guardian is unable to provide legally effective consent.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intranasal xylitol spray<br>Two sprays each nostril, twice a day. | Drug: Intranasal xylitol spray<br>* Two sprays into each nostril of intranasal xylitol spray will be administered to pediatric patients by parent(s)/caregiver(s) twice daily for 24 weeks.<br>|
| Placebo Comparator: Intranasal saline spray<br>Two sprays each nostril, twice a day. | Other: Intranasal saline spray<br>* Two sprays into each nostril of intranasal xylitol spray will be administered to pediatric patients by parent(s)/caregiver(s) twice daily for 24 weeks.<br>* Other names: Placebo spray;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to middle ear effusion resolution |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effect of intranasal xylitol on resolution of the conductive hearing loss associated with middle ear effusion | Results from both audiometry and tympanometry testing are combined to have a comprehensive assessment of conductive hearing loss. | 24 weeks | 
| Effect of intranasal xylitol on frequency of episodes of acute otitis media and sinonasal symptoms |  | 24 weeks | 
| Tolerability and side effects of intranasal xylitol administration in children | Will be evaluated descriptively and include all subjects exposed to at least one dose of study drug | 24 weeks | 
| Tympanostomy tube (TT) placement need | The number of subjects that need TT placement in each arm will be assessed. | 24 weeks |