MedDataX Logo

Xylitol for Otitis Media

NCT ID: NCT02950311

Last Updated: 2017-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-20

Study Completion Date

2017-11-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Otitis Media With Effusion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intranasal xylitol spray

Two sprays each nostril, twice a day.

Group Type EXPERIMENTAL

Intranasal xylitol spray

Intervention Type DRUG

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.

Intranasal saline spray

Two sprays each nostril, twice a day.

Group Type PLACEBO_COMPARATOR

Intranasal saline spray

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intranasal xylitol spray

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.

Intervention Type DRUG

Intranasal saline spray

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Placebo spray

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Duke University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marissa Ryan, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pro00072658

Identifier Type: -

Identifier Source: org_study_id