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

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ClinicalTrials.gov Identifier: NCT01000272
Recruitment Status : Completed
First Posted : October 23, 2009
Last Update Posted : June 26, 2014
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

October 20, 2009
October 23, 2009
June 26, 2014
December 2009
October 2012   (Final data collection date for primary outcome measure)
Fraction of exhaled Nitric Oxide (FeNO) [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT01000272 on ClinicalTrials.gov Archive Site
Spirometry [ Time Frame: 1 year ]
Same as current
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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
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.

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.

Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample
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
Inflammatory Bowel Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
October 2012
October 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
4 Years to 18 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
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Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
Not Provided
Principal Investigator: Yakov Sivan, Associate Professor Tel Aviv Medical Center
Tel-Aviv Sourasky Medical Center
October 2009