Intestinal Inflammation in CF Patients

Cystic Fibrosis Clinical Trial

Official title:

Interrogation of the Prevalence of Intestinal Inflammation in Cystic Fibrosis Patients and the Correlation With Abdominal Symptoms

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04392544
• Other study ID #: 1000060079
• Status: Active, not recruiting
• Start date: September 11, 2018
• Est. completion date: March 31, 2024

Study information

• Verified date: November 2023
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

INCLUSION CRITERIA ;

Pediatric cohort:

1. Diagnosis of CF

2. Informed consent obtained

3. Age 10-18 years

Adult cohort:

1. Diagnosis of CF

2. Informed consent obtained

3. Age = 18 years

4. Patient undergoing a colonoscopy for a clinical indication

EXCLUSION CRITERIA ;

Pediatric Cohort:

1. Patients with the diagnosis of IBD.

2. Patients during an episode of acute gastroenteritis or a pulmonary exacerbation.

Adult cohort:

1. Patients with the diagnosis of IBD.

2. Any health condition, e.g. coagulopathy, sepsis, severe bacterial colitis that would increase the risk for perforation or bleeding when taking intestinal tissue biopsies.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Cystic Fibrosis Gastrointestinal Disease
• Cystic Fibrosis in Children
• Digestive System Diseases
• Fibrosis
• Gastrointestinal Diseases
• Inflammation

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Canadian Cystic Fibrosis Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure fecal calprotectin levels in stool samples of CF pediatric population to determine prevalence of intestinal inflammation.		Day 1
Primary	Assess the correlation between fecal calprotectin levels and abdominal symptoms.		Day 1
Primary	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
Primary	Determine the correlation between fecal calprotectin and histological-proven intestinal inflammation in adult CF patients.		Day 1
Primary	Assess the correlation between histological-proven intestinal inflammation and abdominal symptoms in adult CF patients.		Day 1