Study of the Effects of Probiotics on the Upper Respiratory Tract Microbiome and the Prevention of Otitis Media With Effusion in Children With Cleft Palate
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of episodes of otorrea
研究概览
简要总结
Otitis media with effusion (OME) involves fluid accumulation in the middle ear without infection, sometimes causing discomfort and hearing loss in children. Persistent middle ear fluid lasting over 3 months may require treatment, including placement of ventilation tubes if it affects hearing.
Children with a cleft palate are at higher risk for otorrea after ventilation tube placement. Treatment typically involves antibiotic drops and ear cleaning by an ENT doctor, often requiring repeated visits, which may impact quality of life for both the child and the parents.
The mouth, throat, and nose harbor bacteria that can influence ear infections. This study aims to determine if probiotics can alter the bacteria in the nasopharynx and middle ear fluid and reduce the number of episodes of eardischarge following ventilation tube placement in children with cleft palate.
Using Lacticaseibacillus rhamnosus GG and Bifidobacterium lactis BB-12 from Bactiol® Baby (Metagenics), patients will be divided into two groups: one receiving probiotic drops and one not. The study will assess if probiotics can reduce the number of episodes with ear discharge in children with cleft palate, by examining the following:
- The airway microbiome composition in children with cleft palates.
- Whether oral probiotics can reduce the number and duration of ear discharge episodes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cleft palate & lip (uni/bilateral) or cleft palate
- •No syndromal disorders
排除标准
- •syndromal disorder
- •history of ventilation tube placement
结局指标
主要结局
Number of episodes of otorrea
时间窗: over the study period (= 13 months)
Document the number and duration of episodes of otorrea after ventilation tube placement
Microbiome composition
时间窗: over the study period (= 13 months)
Longitudinal study of the composition of the URT microbiome (alpha, beta diversity and individual taxa), more specific the oral cavity, rhinopharynx, and middle ears. Analysis will be done with 16S amplicon sequencing or shotgun sequencing.
次要结局
- Differences in abundances of lactic acid bacteria in control/probiotic treatment group(over the study period (= 13 months))
- Transfer of bacteria(over the study period (= 13 months))
- Effect of probiotics on the composition of the URT microbiome(over the study period (= 13 months))