Nasal Xylitol in the Prevention of Otitis Media
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Status
Patrocinadores
Rambam Health Care Campus
Colaboradores
HaEmek Medical Center, Israel
Carmel Medical Center
ENSAIO CLÍNICO: NCT02592382
BioSeek: NCT02592382
Palavras-chave
Resumo
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 if 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.
In this study the investigators aim to test the yield of Xylitol nasal spray compared to isotonic saline spray in prevention of recurrent AOM.
datas
| Última verificação: | 10/31/2015 |
| Enviado pela primeira vez: | 10/28/2015 |
| Inscrição estimada enviada: | 10/28/2015 |
| Postado pela primeira vez: | 10/29/2015 |
| Última atualização enviada: | 11/18/2015 |
| Última atualização postada: | 11/19/2015 |
| Data real de início do estudo: | 12/31/2015 |
| Data Estimada de Conclusão Primária: | 08/31/2017 |
| Data Estimada de Conclusão do Estudo: | 08/31/2017 |
Condição ou doença
Otitis Media
Intervenção / tratamento
Dietary Supplement: Xylitol spray
Other: Isotonic saline spray
Fase
-
Grupos de Armas
| Braço | Intervenção / tratamento |
|---|---|
| Placebo Comparator: Isotonic saline spray Isotonic saline (0.9% of NACL) given as nasal spray 3 times a day ( one puff for each nostril) for a two months period | Other: Isotonic saline spray saline nasal spray will be administered to this arm three times daily for two months |
| Experimental: Xylitol spray Solid Xylitol diluted in normal saline(0.9% NACL) to a concentration of 5%. given as a nasal spray 3 times a day(one puff for each nostril) for two months period | Dietary Supplement: Xylitol spray xylitol nasal spray will be administered to this arm three times daily for two months |
Critério de eleição
| Idades qualificadas para estudar | 1 Year Para 1 Year |
| Sexos elegíveis para estudo | All |
| Aceita Voluntários Saudáveis | sim |
| Critério | 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: 1. Children with immune deficiency 2. Children with craniofacial malformations 3. Children with chronic otitis media 4. Children that received prophylactic antibiotic treatment prior to entering the study (3 months ) |
Resultado
Medidas de Resultado Primário
1. prevalence of otitis media [5 months]
the number of events of acute otitis media during the study period of 5 months
Medidas de Resultado Secundário
1. Side effects of treatment [2 months]
any side effects of the treatment will be recorded
