Intestinal Inflammation in CF Patients

Active, not recruiting

• Conditions: Cystic Fibrosis in Children; Cystic Fibrosis; Cystic Fibrosis Gastrointestinal Disease

• Registration Number: NCT04392544
• Lead Sponsor: The Hospital for Sick Children

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 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.

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 populations.

Pediatric CF population (Age 10-18 years):

1. Determine the prevalence of intestinal inflammation in a cohort of pediatric CF patients based on fecal calprotectin levels in stool samples.

2. Assess the correlation between fecal calprotectin and abdominal symptoms/QOL.

Adult CF population (Age ≥ 18 years):

1. 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

1. in adult CF patients who have not undergone lung or liver transplantation.

2. in adult CF patients who have undergone lung or liver transplantation.

2. Assess the correlation between fecal calprotectin and histological-proven intestinal inflammation in adult CF patients.

3. Assess the correlation between histological-proven intestinal inflammation and abdominal symptoms/QOL as well as the correlation between fecal calprotectin and abdominal symptoms/QOL.

Study Timeline

• Study Start: 2018-09-11
• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-13
• Study First Posted: 2020-05-19
• Primary Completion: 2024-03-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-20
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the correlation between fecal calprotectin levels and abdominal symptoms.	Day 1
Determine the correlation between fecal calprotectin and histological-proven intestinal inflammation in adult CF patients.	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.	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.	Day 1
Assess the correlation between histological-proven intestinal inflammation and abdominal symptoms in adult CF patients.	Day 1

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada