Respiratory Tract Inflammation in Children With Inflammatory Bowel Disease (IBD)
The purpose of this study is to determine whether inflammatory bowel disease in children involve the respiratory tract as expressed by increased levels of the Fraction of exhaled Nitric Oxide (FeNO) and spirometry.
Inflammatory Bowel Disease
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Pulmonary Inflammation in Children With Inflammatory Bowel Disease as Expressed by the Fraction of Exhaled Nitric Oxide Levels and Spirometry|
- Fraction of exhaled Nitric Oxide (FeNO) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Spirometry [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||December 2009|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Inflammatory bowel disease, Crohn's disease (CD) and Ulcerative colitis (UC) are chronic inflammatory diseases with remissions and exacerbations. CD and UC are associated with a variety of systemic (extra-intestinal) manifestations. In some studies, clinical and subclinical pulmonary abnormalities are described in active IBD as well as in the stable situation.
Nitric oxide (NO) is an important mediator of inflammation in several pathological conditions.Patients with lung diseases, like asthma, have higher levels of the Fraction of exhaled Nitric Oxide (FeNO) in active disease in comparison with healthy volunteers. One study in adult IBD patients showed increase in FeNO levels in those patients, with positive correlation with the disease activity and negative correlation between the disease activity and pulmonary functions.
We hypothesised that respiratory tract inflammation as expressed by FeNO and spirometry in pediatric IBD patients will correlate to the activity of the primary disease.
Methods: FeNO levels and spirometry will be assess for 40 patients with CD or UC (age 4-18 years) during remissions and exacerbations, calculated by the Pediatrics Crohn's Disease Activity Index (PCDAI) and the Pediatrics Ulcerative Colitis Activity Index (PUCAI), respectively.
Two aged matched groups, the first of healthy children and the second of chronic abdominal pain will serve a controls.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01000272
|"DANA" childrens hospitall|
|Tel Aviv, Israel|
|Principal Investigator:||Yakov Sivan, Associate Professor||Tel Aviv Medical Center|