Xylitol for Otitis Media (NCT02950311) | Clinical Trial Compass
WithdrawnPhase 2/3
Xylitol for Otitis Media
Stopped: On clinical hold with the FDA. Insufficient funds to conduct the study
0Started 2017-11-20
Plain-language summary
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.
Who can participate
Age range6 Months – 3 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.