Study of the Upper Respiratory Tract Microbiota and the Potential of Probiotics for the Treatment of Chronic Otitis Media With Effusion.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Microbiota differences between the healthy and diseased URT and middle ear space
研究概览
简要总结
This study analyses which bacteria are present in the middle ear space and adjacent upper respiratory tract niches in healthy people and in patients suffering from chronic otitis media with effusion (OME; glue ear). The aim is to identify and isolate bacteria that are more common and more abundant in healthy people and to evaluate their potential to protect against bacteria commonly involved in OME and other upper respiratory tract infections.
To this end, samples will be collected from both groups (healthy vs OME) and analysed through sequencing of the bacterial 16S gene. In addition, samples obtained from healthy participants will be cultivated to isolate bacteria of interest.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 1 Year 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Controls: undergo a surgery that gives access to the middle ear space (at least 30 participants; e.g. cochlear implant recipients) or the adenoids.
- •OME patients: have fluid accumulation in the middle ear space for 3+ months and receive ventilation tubes. May also undergo adenoidectomy.
排除标准
- •Acute upper respiratory tract infections (including acute otitis media)
- •Chronic upper respiratory tract infections (except OME in patient group)
- •URT malformations (e.g. as seen in people with Down Syndrome or cleft palate)
- •Cystic fibrosis
- •Autoimmune diseases or immunodeficiency
- •Pregnancy
- •Use of antibiotics or steroids 1 week before surgery
结局指标
主要结局
Microbiota differences between the healthy and diseased URT and middle ear space
时间窗: Appr. 4 years
The composition of the bacterial community will be determined through sequencing of the bacterial 16S gene and compared between the participant groups. Species over-represented in healthy participants will be investigated further.
次要结局
未报告次要终点
研究者
Ethisch Comité, UZA
prof. dr. Olivier Vanderveken, MD, PhD
University Hospital, Antwerp