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Active, Not Recruiting

NCT Number: NCT04392544

Intestinal Inflammation in CF Patients

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cystic Fibrosis in Children Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Cystic Fibrosis Gastrointestinal Disease Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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):

  • Determine the prevalence of intestinal inflammation in a cohort of pediatric CF patients based on fecal calprotectin levels in stool samples.
  • Assess the correlation between fecal calprotectin and abdominal symptoms/QOL.

Adult CF population (Age ≥ 18 years):

  • 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
  • in adult CF patients who have not undergone lung or liver transplantation.
  • in adult CF patients who have undergone lung or liver transplantation.
  • Assess the correlation between fecal calprotectin and histological-proven intestinal inflammation in adult CF patients.
  • Assess the correlation between histological-proven intestinal inflammation and abdominal symptoms/QOL as well as the correlation between fecal calprotectin and abdominal symptoms/QOL.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Measure fecal calprotectin levels in stool samples of CF pediatric population to determine prevalence of intestinal inflammation.

    Time frame: Day 1

  2. Assess the correlation between fecal calprotectin levels and abdominal symptoms.

    Time frame: Day 1

  3. 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.

    Time frame: Day 1

    Sub groups; with and without lung or liver transplantation.

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

    Time frame: Day 1

  5. Assess the correlation between histological-proven intestinal inflammation and abdominal symptoms in adult CF patients.

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Canadian Cystic Fibrosis Foundation

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2025
First posted
May 19, 2020
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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