Interrogation of the Prevalence of Intestinal Inflammation in Cystic Fibrosis Patients and the Correlation with Abdominal Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Assess the correlation between fecal calprotectin levels and abdominal symptoms.
研究概览
简要总结
Cystic Fibrosis (CF) is a disease that affects salt and water transport in multiple organs. Many CF patients suffer from abdominal pain and this could be due to intestinal inflammation. However, so far we do not know how many of the CF patients actually do have intestinal inflammation when looking at intestinal specimens. There is a proven connection between chronic inflammation and developing colorectal cancer and over the years more CF patients are developing colorectal cancer. Thus, it becomes increasingly important to look for the presence of intestinal inflammation in CF patients since early treatment may improve their symptoms and reduce the risk for colorectal cancer.
详细描述
The aim is to determine the prevalence of intestinal inflammation by measurement of fecal calprotectin and/or histological evaluation of intestinal tissue biopsies in both pediatric and adult CF populations.
Pediatric CF population (Age 10-18 years):
- Determine the prevalence of intestinal inflammation in a cohort of pediatric CF patients based on fecal calprotectin levels in stool samples.
- Assess the correlation between fecal calprotectin and abdominal symptoms/QOL.
Adult CF population (Age ≥ 18 years):
- Determine the prevalence of intestinal inflammation in a cohort of adult CF patients based on histological evaluation of intestinal tissues biopsies and fecal calprotectin levels in stool samples
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Assess the correlation between fecal calprotectin levels and abdominal symptoms.
时间窗: Day 1
Determine the correlation between fecal calprotectin and histological-proven intestinal inflammation in adult CF patients.
时间窗: Day 1
Determine the prevalence of intestinal inflammation in adult CF patients based on histological evaluation of intestinal tissues biopsies and fecal calprotectin levels in stool samples.
时间窗: Day 1
Sub groups; with and without lung or liver transplantation.
Measure fecal calprotectin levels in stool samples of CF pediatric population to determine prevalence of intestinal inflammation.
时间窗: Day 1
Assess the correlation between histological-proven intestinal inflammation and abdominal symptoms in adult CF patients.
时间窗: Day 1
次要结局
未报告次要终点
研究者
Tanja Gonska
Associate Professor and Senior Associate Scientist
The Hospital for Sick Children