GRINCH: Groningen Initiative on Reference Intervals in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Levels of Calgranulin C (S100A12) in healthy children
研究概览
简要总结
The purpose of this study is to establish reliable reference intervals for fecal S100A12 in healthy children.
详细描述
RATIONALE S100A12 (calgranulin C) is a cytoplasmic protein secreted exclusively by activated neutrophils. It can be measured in stools and elevated levels are observed in children with inflammatory bowel disease. The protein is stable in stool samples for up to seven days at room temperature, which allows collection at home and potential delays in transport to the laboratory. S100A12 could be used as a marker to discriminate between pediatric inflammatory and functional gastro-intestinal conditions, and prevent children with a low probability of inflammation from unnecessary endoscopic procedures. Until now a reliable reference interval for healthy children is lacking.
OBJECTIVE To establish reliable reference intervals for fecal S100A12 in healthy children.
TIME FRAME Healthy children will be asked to send in one feces sample anonymously during the inclusion period. The investigators expect that the required 120 samples will be collected before December 2015. There will be no follow up of patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Treated for any gastro-intestinal symptoms
- •Diarrhea in the last week before the collection of the feces sample
- •Fever in the last week before collection of the feces sample
- •Use of NSAIDs of Proton pump inhibitors in the last 14 days before collection feces sample.
结局指标
主要结局
Levels of Calgranulin C (S100A12) in healthy children
时间窗: One measurement at baseline
次要结局
未报告次要终点
研究者
P.F. van Rheenen
Dr.
University Medical Center Groningen