Status:
ACTIVE_NOT_RECRUITING
Intestinal Inflammation in CF Patients
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
Canadian Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis in Children
Cystic Fibrosis Gastrointestinal Disease
Eligibility:
All Genders
10+ years
Brief Summary
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 fa...
Detailed Description
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 popul...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA ;
- Pediatric cohort:
- Diagnosis of CF
- Informed consent obtained
- Age 10-18 years
- Adult cohort:
- Diagnosis of CF
- Informed consent obtained
- Age ≥ 18 years
- Patient undergoing a colonoscopy for a clinical indication
- EXCLUSION CRITERIA ;
- Pediatric Cohort:
- Patients with the diagnosis of IBD.
- Patients during an episode of acute gastroenteritis or a pulmonary exacerbation.
- Adult cohort:
- Patients with the diagnosis of IBD.
- Any health condition, e.g. coagulopathy, sepsis, severe bacterial colitis that would increase the risk for perforation or bleeding when taking intestinal tissue biopsies.
Exclusion
Key Trial Info
Start Date :
September 11 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04392544
Start Date
September 11 2018
End Date
December 31 2025
Last Update
January 20 2025
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8