Nasal Xylitol in the Prevention of Otitis Media | NCT02592382

Studies
Nasal Xylitol in the Prevention of Otitis Media

NCT02592382

Sponsor

Rambam Health Care Campus

Status

Completed

Last Update Posted

Oct 31, 2023Actual

Enrollment

70Actual

Phase

Not Applicable

Conditions

Otitis Media

Interventions

Xylitol spray

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2019Actual

Primary Completion Date

Aug 1, 2023Actual

Completion Date

Sep 1, 2023Actual

First Submitted Date

Oct 29, 2015

First Submission Date that Met QC Criteria

Oct 29, 2015

First Posted Date

Oct 30, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 29, 2023

Last Update Posted Date

Oct 31, 2023Actual

Name	Class
Carmel Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Xylitol spray	Dietary Supplement	xylitol nasal spray will be administered to this arm three times daily for three months	Xylitol spray

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

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.

Eligibility Module

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:

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 )

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

5 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arie Gordin, MD	Rambam Health Care Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam Health Care Campus		Haifa		31096	Israel
Carmel Medical Center

Condition Browse Module

MeSH Terms

ID	Term
D010033	Otitis Media

Ancestor Terms

ID	Term
D010031	Otitis
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided