Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Canadian Cystic Fibrosis Foundation | OTHER |
Not provided
Not provided
Not provided
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.
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):
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
Assess the correlation between fecal calprotectin and histological-proven intestinal inflammation in adult CF patients.
Assess the correlation between histological-proven intestinal inflammation and abdominal symptoms/QOL as well as the correlation between fecal calprotectin and abdominal symptoms/QOL.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric | Pediatric CF population age 10-18 years. | ||
| Adult | Adult CF population age ≥ 18 years. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Measure fecal calprotectin levels in stool samples of CF pediatric population to determine prevalence of intestinal inflammation. | Day 1 | |
| Assess the correlation between fecal calprotectin levels and abdominal symptoms. | 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. | Sub groups; with and without lung or liver transplantation. | Day 1 |
| Determine the correlation between fecal calprotectin and histological-proven intestinal inflammation in adult CF patients. | Day 1 | |
| Assess the correlation between histological-proven intestinal inflammation and abdominal symptoms in adult CF patients. | Day 1 |
Not provided
Not provided
INCLUSION CRITERIA ;
Pediatric cohort:
Adult cohort:
EXCLUSION CRITERIA ;
Pediatric Cohort:
Adult cohort:
Not provided
Not provided
Not provided
Pediatric and adult population diagnosed of cystic fibrosis will be included in this study.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tanja Gonska, MD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
Not provided
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Stool samples to assess Calprotectin levels.
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |