Respiratory Tract Inflammation in Children With Inflammatory Bowel Disease (IBD)

Completed

• Conditions: Inflammatory Bowel Disease

• Registration Number: NCT01000272
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

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.

Study Timeline

• Status Verified: 2009-10
• Study First Submitted: 2009-10-20
• Study First Submitted QC: 2009-10-22
• Study First Posted: 2009-10-23
• Study Start: 2009-12
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Last Update Submitted: 2014-06-25
• Last Update Posted: 2014-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. 4-18 years old children diagnosed with IBD:

   • Histological diagnosis of Crohn's disease
   • Histological diagnosis of Ulcerative colitis

2. Negative stool cultures

Exclusion Criteria

1. Respiratory tract infection during the 6 weeks prior to enrollment
2. Diagnosis of asthma
3. Current treatment with steroids
4. Smoking

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fraction of exhaled Nitric Oxide (FeNO)	1 year

Secondary Outcome Measures

Name	Time	Method
Spirometry	1 year

Trial Locations

Locations (1)

"DANA" childrens hospitall; 🇮🇱 Tel Aviv, Israel