Nasal Xylitol in the Prevention of Otitis Media

Nasal Xylitol for Recurrent Otitis Media

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 of 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. It was proven to reduce the ability of bacteria to attach to the mucosa of the upper respiratory system. Previous study had shown that oral usage of Xylitol (as chewing gum or syrup) can reduce the incidence of rAOM by 30% as compared to placebo. But this treatment did not gain popularity since the initial clinical trial 30 years. There are several potential reasons for that. First, Xylitol should be administrated 5 times daily in order to be effective. Study that checked usage of oral Xylitol 3 times daily in children with rAOM did not find additional advantage as compared to placebo. Secondly, by using Xylitol orally we rely on the gut absorption and systemic distribution. Xylitol absorbs poorly in the gut and can cause some GI symptoms (like nausea and diarrhea) especially when used in a syrup (the preferred way in small children).

In this study the investigators aim to test the yield of Xylitol nasal spray as a preventive treatment in children with rAOM. By using Xylitol as nasal spray we deliver the active compound directly to the action site (nasopharynx- the AOM reservoir) and avoid the GI side effects

Study Overview

• Status: Completed
• Conditions: Otitis Media
• Intervention / Treatment: Dietary supplement: Xylitol spray

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 31096
    • Rambam Health Care Campus
  • Haifa, Israel
    • Carmel Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 )

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Xylitol spray; Xylitol nasal spray ( Xlear ltd which contains 10% of Xylitiol) given 3 times a day (one puff for each nostril) for three months period.	Dietary supplement: Xylitol spray; xylitol nasal spray will be administered to this arm three times daily for three months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prevalence of otitis media episodes	The number of events of acute otitis media during the study period of 6 months. The comparison is in 3 months intervals. pre-treatment, during treatment and post-treatment	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects of treatment	any side effects of the treatment will be recorded	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antimicrobial treatment	Collect the type (systemic or topical) of antimicrobial treatment prior and during the study	9 months
Parental diary	The parents will conduct a diary that will include AOM episodes, who made the diagnosis, what were the symptoms and what kind of treatment was given.	6 months

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Collaborators: Carmel Medical Center
• Investigators: Principal Investigator: Arie Gordin, MD, Rambam Health Care Center

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: October 29, 2015
• First Submitted That Met QC Criteria: October 29, 2015
• First Posted (Estimated): October 30, 2015

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 29, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media
• Other Study ID Numbers: 0429-13-rmb/CTIL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No