Intestinal Inflammation in CF Patients

NCT04392544 | Active Not Recruiting

• 1 other identifier: 1000060079
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis in Children; Cystic Fibrosis Gastrointestinal Disease; Cystic Fibrosis

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Pediatric

Pediatric CF population age 10-18 years.

Adult

Adult CF population age ≥ 18 years.

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Canadian Cystic Fibrosis Foundation: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool samples to assess Calprotectin levels.

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Tanja Gonska, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Senior Associate Scientist

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 19, 2020
• Study Start: September 11, 2018
• Primary Completion: March 31, 2024
• Study Completion: December 31, 2025
• Last Updated: January 20, 2025

Record last verified: 2025-01

Locations

CA (1)