Intestinal Inflammation in CF Patients

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cystic Fibrosis; Cystic Fibrosis Gastrointestinal Disease; Cystic Fibrosis in Children

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Tanja Gonska, MD; Phone Number: 207735 416-813-7735; Email: Tanja.gonska@sickkids.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pediatric and adult population diagnosed of cystic fibrosis will be included in this study.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Pediatric; Pediatric CF population age 10-18 years.
Adult; Adult CF population age ≥ 18 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: Canadian Cystic Fibrosis Foundation
• Investigators: Principal Investigator: Tanja Gonska, MD, The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2018
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 13, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Inflammation; Gastrointestinal Diseases; Digestive System Diseases; Cystic Fibrosis
• Other Study ID Numbers: 1000060079

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No