Clinical trial NCT01000272: Respiratory Tract Inflammation in Children With Inflammatory Bowel Disease (IBD)
Official title: Pulmonary Inflammation in Children With Inflammatory Bowel Disease as Expressed by the Fraction of Exhaled Nitric Oxide Levels and Spirometry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-10-23
Enrollment: 45
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patients with IBD addmited to the pediatric ward due to exacerbations and children with IBD who come for routine visit to the pediatric gastroenterology clinic at the "DANA" Hospital for Childrens, at the Sourasky Medical Center, Tel-Aviv

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fraction of exhaled Nitric Oxide (FeNO)
timeFrame: 1 year
Secondary outcomes:
measure: Spirometry
timeFrame: 1 year
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: "DANA" childrens hospitall
Study officials:
affiliation: Tel Aviv Medical Center
name: Yakov Sivan, Associate Professor
role: PRINCIPAL_INVESTIGATOR
References: