Clinical trial NCT02592382: Nasal Xylitol in the Prevention of Otitis Media
Official title: Nasal Xylitol for Recurrent Otitis Media
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Otitis Media
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
Collaborators: name: Carmel Medical Center
First posted: 2015-10-30
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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


Eligibility criteria: 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 )

Primary outcomes:
measure: prevalence of otitis media episodes
timeFrame: 6 months
Secondary outcomes:
measure: Side effects of treatment
timeFrame: 3 months
Other outcomes:
measure: Antimicrobial treatment
timeFrame: 9 months
measure: Parental diary
timeFrame: 6 months
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Haifa
country: Israel
facility: Carmel Medical Center
Study officials:
affiliation: Rambam Health Care Center
name: Arie Gordin, MD
role: PRINCIPAL_INVESTIGATOR
References: