NCT02110732已完成不适用
Lactobacillus Rhamnosus GG in the Middle Ear and Adenoid Tonsil After Randomized, Double-blind, Placebo-controlled Oral Administration
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Lactobacillus Rhamnosus GG in Middle Ear Effusion and Adenoid Tonsil
研究概览
简要总结
The purpose of this study is to evaluate the effect of oral administration of probiotic Lactobacillus rhamnosus GG in middle ear and adenoid tonsil.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •recurrent otitis media
- •secretory otitis media
- •chronic rhinitis
- •recurrent sinusitis
排除标准
- •significant illness
结局指标
主要结局
Lactobacillus Rhamnosus GG in Middle Ear Effusion and Adenoid Tonsil
时间窗: After 3 weeks of oral consumption
Presence of Lactobacillus rhamnosus GG in middle ear effusion of children having tympanostomy after oral administration of L. GG.
次要结局
- Presence of Bacterial Pathogens in Middle Ear Effusion Samples(After 3 weeks of oral consumption)
- Presence of Rhinovirus and Enterovirus in Middle Ear Effusion Samples(After 3 weeks of oral consumption)
研究者
Anne pitkäranta
Professor/Chief Physician at Hospital District of Helsinki and Uusimaa
Helsinki University Central Hospital
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