Skip to main content
OpenTrials
Completed

NCT Number: NCT01000272

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

"DANA" childrens hospitall

Tel Aviv, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • Smoking

Treatment and study plan

Primary outcomes

  1. Fraction of exhaled Nitric Oxide (FeNO)

    Time frame: 1 year

Secondary outcomes

  1. Spirometry

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Tel-Aviv Sourasky Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Oct 23, 2009
Registry last updated
Jun 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.