The Salivary Microbiome in Children With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- profile the oral bacteria related to caries and periodontal disease of children with type 1 diabetes mellitus
研究概览
简要总结
Aims: To profile the oral microbiome of children with type 1 diabetes mellitus, and to compare it to healthy children while taking into account other aspects of the oral environment.
Research: exploring the differences between oral microflora of children with type 1 diabetes mellitus and control healthy children using salivary microbiome. The investigators will furthermore intend to analyze the differences of salivary flow rate, pH, glucose, calcium, inorganic phosphate and urea between the two groups.
详细描述
Saliva from 50 children ages 5 to 15 years old who had been diagnosed with type 1 diabetes mellitus and are followed at the Pediatric Endocrinology Clinic, Hadassah University Hospital Mt. Scopus and Ein Kerem, Jerusalem, Isreal, will be compared to 50 healthy children, preferably their siblings, matched in age and gender. Each patient or their legal guardian will sign an informed consent to participate in the study. The investigators will request a permission to access the medical records of the patients. Data will be collected from patient medical history. The investigators will measure salivary flow rate, pH and glucose, salivary Calcium, inorganic phosphate and urea and perform microbiome analysis and 16S rRNA gene-based analysis comparing children with diabetes to healthy children.
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
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with type 1 diabetes mellitus
排除标准
- •Children Unable to give saliva sample
- •Children On antibacterial medicaments
结局指标
主要结局
profile the oral bacteria related to caries and periodontal disease of children with type 1 diabetes mellitus
时间窗: 1 year
Profile salivary microbiota in diabetic children followed by bioinformatics analyses and combining the data with the alteration in caries index, medications, state of the disease and salivary components to give a list of specific bacteria that are different in the diabetic child from healthy population.
次要结局
未报告次要终点