Xylitol for Otitis Media

• Status: Withdrawn
• Trial end date: 2017-11-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University

Criteria

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.