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NCT Number: NCT02592382

Nasal Xylitol in the Prevention of Otitis Media

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

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Key information

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carmel Medical Center, Haifa, Israel

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 )

Treatment and study plan

Xylitol spray

Dietary Supplement

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

Primary outcomes

  1. prevalence of otitis media episodes

    Time frame: 6 months

    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

Secondary outcomes

  1. Side effects of treatment

    Time frame: 3 months

    any side effects of the treatment will be recorded

Other outcomes

  1. Antimicrobial treatment

    Time frame: 9 months

    Collect the type (systemic or topical) of antimicrobial treatment prior and during the study

  2. Parental diary

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Collaborators

  • Carmel Medical Center

Registry information

Official study title

Nasal Xylitol for Recurrent Otitis Media

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 30, 2015
Registry last updated
Oct 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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