Nasal Xylitol in the Prevention of Otitis Media

Not Applicable

Completed

• Conditions: Otitis Media
• Interventions: Dietary Supplement: Xylitol spray

• Registration Number: NCT02592382
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-29
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-10-30
• Study Start: 2019-05-01
• Primary Completion: 2023-08-01
• Study Completion: 2023-09-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-29
• Last Update Posted: 2023-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Xylitol spray	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.

Primary Outcome Measures

Name	Time	Method
prevalence of otitis media episodes	6 months	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

Secondary Outcome Measures

Name	Time	Method
Side effects of treatment	3 months	any side effects of the treatment will be recorded

Trial Locations

Locations (2)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel

Carmel Medical Center; 🇮🇱 Haifa, Israel