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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01000272

Enrollment

Registered

2009-10-23

Start date

2009-12-31

Completion date

2012-10-31

Last updated

2014-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Disease

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

4 Years to 18 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Fraction of exhaled Nitric Oxide (FeNO)	1 year

Secondary

Measure	Time frame
Spirometry	1 year

Countries

Israel

Outcome results