Nasal Xylitol in the Prevention of Otitis Media

Status Completed

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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02592382
Study type	Interventional
Source	Rambam Health Care Campus
Contact
Status	Completed
Phase	N/A
Start date	May 1, 2019
Completion date	September 1, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04016051` - Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections	Phase 3
Completed	`NCT02452164` - Family MobilePhone Otoscopy in Diagnostics of Otitis Media	N/A
Completed	`NCT01199016` - Effect of Prevnar 13 on Ear Infections in Children	Phase 4
Terminated	`NCT00778063` - Study Using Dexmedetomidine to Decreases Emergence Delirium in Pediatric Patients	N/A
Completed	`NCT00195611` - Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media	Phase 4
Recruiting	`NCT03722160` - Clinical Study of the Solo Tympanostomy Tube Device	N/A
Recruiting	`NCT04447521` - Surveillance of Non-invasive Streptococcus Pneumoniae Infections in Belgium
Active, not recruiting	`NCT05127161` - Broad Implementation of Outpatient Stewardship	N/A
Completed	`NCT02600559` - Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes	Phase 3
Completed	`NCT01444391` - inVENT-visIOn Study	N/A
Enrolling by invitation	`NCT01437436` - The Effect of Obesity on Ventilation Tube Insertion	N/A
Completed	`NCT01003210` - Homeopathic Ear Drops for Otitis Media Study	N/A
Completed	`NCT00768534` - Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media	N/A
Recruiting	`NCT00393159` - The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children	Phase 4
Completed	`NCT00617682` - Maternal Immunization To Prevent Infant Otitis Media	Phase 1/Phase 2
Withdrawn	`NCT00956748` - N-Acetylcysteine as an Adjunct for Refractory Chronic Suppurative Otitis Media	Phase 4
Withdrawn	`NCT01908764` - Pharmacokinetic Study of AL-60371 Otic Suspension in Pediatric Subjects Following Tympanostomy Tube Surgery	Phase 1
Recruiting	`NCT01619462` - Safety and Immunogenicity of 10-valent and 13-valent Pneumococcal Conjugate Vaccines in Papua New Guinean Children	Phase 3
Completed	`NCT02616458` - The Impact of Ear Pain Anticipatory Guidance Counseling on Otitis Related Visits in a Low Income Population	N/A
Completed	`NCT00044473` - A Study of the Effectiness and Safety of Levofloxacin in Treating Children With a Rapid and Severe Onset of Infection and Inflammation of the Middle Ear That is Difficult to Treat	Phase 3