Skip to main content
Clinical Trials/NCT01000272
NCT01000272
Completed
Not Applicable

Pulmonary Inflammation in Children With Inflammatory Bowel Disease as Expressed by the Fraction of Exhaled Nitric Oxide Levels and Spirometry

Tel-Aviv Sourasky Medical Center1 site in 1 country45 target enrollmentDecember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Inflammatory Bowel Disease
Sponsor
Tel-Aviv Sourasky Medical Center
Enrollment
45
Locations
1
Primary Endpoint
Fraction of exhaled Nitric Oxide (FeNO)
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
December 2009
End Date
October 2012
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 4-18 years old children diagnosed with IBD:
  • Histological diagnosis of Crohn's disease
  • Histological diagnosis of Ulcerative colitis
  • Negative stool cultures

Exclusion Criteria

  • Respiratory tract infection during the 6 weeks prior to enrollment
  • Diagnosis of asthma
  • Current treatment with steroids

Outcomes

Primary Outcomes

Fraction of exhaled Nitric Oxide (FeNO)

Time Frame: 1 year

Secondary Outcomes

  • Spirometry(1 year)

Study Sites (1)

Loading locations...

Similar Trials