Xylitol for Otitis Media

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02950311
Study type	Interventional
Source	Duke University
Contact
Status	Withdrawn
Phase	Phase 2/Phase 3
Start date	November 20, 2017
Completion date	November 20, 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03590912` - Efficacy and Cost Analysis of Steroids in Treatment of Otitis Media With Effusion	Phase 4
Completed	`NCT03611842` - Study of the Expression of MMPs in OME in Children With Atrophy of the Eardrum
Not yet recruiting	`NCT01421199` - Device Study to Evaluate the Detection and Characterization of Middle Ear Fluid in Children	N/A
Completed	`NCT01202578` - Evaluation of the Tympanostomy Tube Delivery System	Phase 2/Phase 3
Completed	`NCT00629694` - Adenoidectomy, Myringotomy and Tubes' Insertion vs Adenoidectomy and Myringotomy Alone in Children With Otitis Media With Effusion and Adenoid Hypertrophy	Phase 2
Completed	`NCT00520039` - Osteopathic Otitis Media Research Study	N/A
Completed	`NCT00195611` - Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media	Phase 4
Not yet recruiting	`NCT05402267` - The Effects of Exosomes in Otitis Media With Effusion
Not yet recruiting	`NCT04584073` - Secretory Otitis Media in Adenoids Hypertrophy Patients	N/A
Withdrawn	`NCT00736112` - Food Allergy - Tubes - Adenoids (FATA) Trial	N/A
Completed	`NCT00546117` - A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion	N/A
Recruiting	`NCT05324696` - Autoinflation: Alternative in the Treatment of Otitis Media With Effusion	N/A
Recruiting	`NCT05353569` - Coherent Optical Detection of Middle Ear Disease	N/A
Completed	`NCT02282540` - Novel Imaging of the Eustachian Tube; Patient Study	N/A
Not yet recruiting	`NCT03491098` - The Efficacy of Nasal Steroids in Treatment of Otitis Media With Effusion: Acomparative Study	Early Phase 1
Completed	`NCT01082029` - Study of Anti-reflux Medication as a Potential Treatment for Glue Ear in Children	Phase 4
Completed	`NCT00939796` - Clinical Study of the Tympanostomy Tube Delivery System	N/A
Recruiting	`NCT06316635` - Microplastics in Otitis Media With Effusion Material
Recruiting	`NCT02215681` - Acupuncture Effect on Inflammatory Markers in Pediatric Otitis Media With Effusion: A Pilot Study	N/A
Completed	`NCT02183974` - Suitable Method for Routine Diagnostics of EER in Children With Otitis Media With Effusion	N/A