Nasal Xylitol in the Prevention of Otitis Media

Otitis Media Clinical Trial

Official title:

Nasal Xylitol for Recurrent Otitis Media

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02592382
• Other study ID #: 0429-13-rmb/CTIL
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: September 1, 2023

Study information

• Verified date: October 2023
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

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 )

Related Conditions & MeSH terms

• Otitis
• Otitis Media

Intervention

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

Locations

Country	Name	City	State
Israel	Carmel Medical Center	Haifa
Israel	Rambam Health Care Campus	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
Rambam Health Care Campus	Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Antimicrobial treatment	Collect the type (systemic or topical) of antimicrobial treatment prior and during the study	9 months
Other	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
Primary	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	Side effects of treatment	any side effects of the treatment will be recorded	3 months