Respiratory Tract Inflammation in Children With Inflammatory Bowel Disease (IBD)
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|ClinicalTrials.gov Identifier: NCT01000272|
Recruitment Status : Completed
First Posted : October 23, 2009
Last Update Posted : June 26, 2014
|Condition or disease|
|Inflammatory Bowel Disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||45 participants|
|Observational Model:||Case Control|
|Official Title:||Pulmonary Inflammation in Children With Inflammatory Bowel Disease as Expressed by the Fraction of Exhaled Nitric Oxide Levels and Spirometry|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
- Fraction of exhaled Nitric Oxide (FeNO) [ Time Frame: 1 year ]
- Spirometry [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01000272
|"DANA" childrens hospitall|
|Tel Aviv, Israel|
|Principal Investigator:||Yakov Sivan, Associate Professor||Tel Aviv Medical Center|