NCT02592382

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2015

Completed
3.5 years until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

4.3 years

First QC Date

October 29, 2015

Last Update Submit

October 29, 2023

Conditions

Otitis Media

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Side effects of treatment

    3 months

Other Outcomes (2)

  • Antimicrobial treatment

    9 months

  • Parental diary

    6 months

Study Arms (1)

Xylitol spray

EXPERIMENTAL

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

Interventions

Xylitol sprayDIETARY_SUPPLEMENT

xylitol nasal spray will be administered to this arm three times daily for three months

Xylitol spray

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \. 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rambam Health Care Campus

Haifa, 31096, Israel

Location

Carmel Medical Center

Haifa, Israel

Location

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Arie Gordin, MD

    Rambam Health Care Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2015

First Posted

October 30, 2015

Study Start

May 1, 2019

Primary Completion

August 1, 2023

Study Completion

September 1, 2023

Last Updated

October 31, 2023

Record last verified: 2023-10

Locations

IL(2)