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临床试验/NCT02592382
NCT02592382已完成不适用

Nasal Xylitol for Recurrent Otitis Media

Rambam Health Care Campus3 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
3
主要终点
prevalence of otitis media episodes

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
1 Year 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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 )

结局指标

主要结局

prevalence of otitis media episodes

时间窗: 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

次要结局

  • Side effects of treatment(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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