Nasal Xylitol in the Prevention of Otitis Media

Overview

Acute otitis media (AOM) is one of the most prevalent and costly illnesses in children throughout the world. AOM can lead to chronic otitis media with effusion (OME) resulting in conductive hearing loss that can cause speech, language, academic, and social developmental delays. Complementary and alternative medicines are being widely used for prevention of AOM. Xylitol is a five carbon polyol (sugar alcohol) produced from natural plants and is used for preventing dental caries and AOM in children. It is commercially available in chewing gums, syrups and toothpastes washes, and other products. Xylitol was shown in several studies to prevent the culture if bacteria in the nasopharynx and oral cavity. It was proven to eliminate the ability of bacteria to attach to the mucosa of the upper respiratory system. In this study the investigators aim to test the yield of Xylitol nasal spray compared to isotonic saline spray in prevention of recurrent AOM.

Full Title of Study: “Nasal Xylitol for Recurrent Otitis Media”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: September 2017

Interventions

  • Dietary Supplement: Xylitol spray
    • xylitol nasal spray will be administered to this arm three times daily for two months
  • Other: Isotonic saline spray
    • saline nasal spray will be administered to this arm three times daily for two months

Arms, Groups and Cohorts

  • Placebo Comparator: Isotonic saline spray
    • Isotonic saline (0.9% of NACL) given as nasal spray 3 times a day ( one puff for each nostril) for a two months period
  • Experimental: Xylitol spray
    • Solid Xylitol diluted in normal saline(0.9% NACL) to a concentration of 5%. given as a nasal spray 3 times a day(one puff for each nostril) for two months period

Clinical Trial Outcome Measures

Primary Measures

  • prevalence of otitis media
    • Time Frame: 5 months
    • the number of events of acute otitis media during the study period of 5 months

Secondary Measures

  • Side effects of treatment
    • Time Frame: 2 months
    • any side effects of the treatment will be recorded

Participating in This Clinical Trial

Inclusion Criteria

1. Children at the age of 1-5 years that suffered from recurrent otitis media (3 episodes in the last 6 months prior to entrance to the study) Exclusion Criteria:

1. Children with immune deficiency 2. Children with craniofacial malformations 3. Children with chronic otitis media 4. Children that received prophylactic antibiotic treatment prior to entering the study (3 months )

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 5 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Rambam Health Care Campus
  • Collaborator
    • HaEmek Medical Center, Israel
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Arie Gordin, MD, Principal Investigator, Rambam Health Care Center
  • Overall Contact(s)
    • Arie Gordin, MD, 972502061264, a_gordin@rambam.health.gov.il

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