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

Inflammatory Bowel Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01000272
• Other study ID #: TASMC-09-YS-439-CTIL
• Status: Completed
• Phase: N/A
• First received: October 20, 2009
• Last updated: June 25, 2014
• Start date: December 2009
• Est. completion date: October 2012

Study information

• Verified date: October 2009
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Locations

Country	Name	City	State
Israel	"DANA" childrens hospitall	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fraction of exhaled Nitric Oxide (FeNO)		1 year
Secondary	Spirometry		1 year