Clinical Trial: Xylitol for Otitis Media

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary: 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.
Sponsor: Duke University

Current Primary Outcome: Time to middle ear effusion resolution [ Time Frame: 24 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Duke University

Dates:
Date Received: October 19, 2016
Date Started: February 2017
Date Completion: October 2017
Last Updated: December 5, 2016
Last Verified: December 2016