Other Clinical Trial - 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

See also
Status	Clinical Trial	Phase
Completed	`NCT04696198` - Thoracic Mobility in Cystic Fibrosis Care	N/A
Completed	`NCT00803205` - Study of Ataluren (PTC124™) in Cystic Fibrosis	Phase 3
Terminated	`NCT04921332` - Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD	N/A
Completed	`NCT03601637` - Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del	Phase 3
Terminated	`NCT02769637` - Effect of Acid Blockade on Microbiota and Inflammation in Cystic Fibrosis (CF)
Recruiting	`NCT06032273` - Lung Transplant READY CF 2: CARING CF Ancillary RCT	N/A
Recruiting	`NCT06030206` - Lung Transplant READY CF 2: A Multi-site RCT	N/A
Recruiting	`NCT06012084` - The Development and Evaluation of iCF-PWR for Healthy Siblings of Individuals With Cystic Fibrosis	N/A
Recruiting	`NCT05392855` - Symptom Based Performance of Airway Clearance After Starting Highly Effective Modulators for Cystic Fibrosis (SPACE-CF)	N/A
Recruiting	`NCT06088485` - The Effect of Bone Mineral Density in Patients With Adult Cystic Fibrosis
Recruiting	`NCT04056702` - Impact of Triple Combination CFTR Therapy on Sinus Disease.
Recruiting	`NCT04039087` - Sildenafil Exercise: Role of PDE5 Inhibition	Phase 2/Phase 3
Completed	`NCT04038710` - Clinical Outcomes of Triple Combination Therapy in Severe Cystic Fibrosis Disease.
Completed	`NCT04058548` - Clinical Utility of the 1-minute Sit to Stand Test as a Measure of Submaximal Exercise Tolerance in Patients With Cystic Fibrosis During Acute Pulmonary Exacerbation	N/A
Completed	`NCT03637504` - Feasibility of a Mobile Medication Plan Application in CF Patient Care	N/A
Recruiting	`NCT03506061` - Trikafta in Cystic Fibrosis Patients	Phase 2
Completed	`NCT03566550` - Gut Imaging for Function & Transit in Cystic Fibrosis Study 1
Recruiting	`NCT04828382` - Prospective Study of Pregnancy in Women With Cystic Fibrosis
Completed	`NCT04568980` - Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
Recruiting	`NCT04010253` - Impact of Bronchial Drainage Technique by the Medical Device Simeox® on Respiratory Function and Symptoms in Adult Patients With Cystic Fibrosis	N/A

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.