Intestinal Inflammation in CF Patients

Status Active, not recruiting

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

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

Clinical Trial Details

NCT number	NCT04392544
Study type	Observational
Source	The Hospital for Sick Children
Contact
Status	Active, not recruiting
Phase
Start date	September 11, 2018
Completion date	March 31, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.