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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
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

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.

Condition or disease
Inflammatory Bowel Disease

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.


Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pulmonary Inflammation in Children With Inflammatory Bowel Disease as Expressed by the Fraction of Exhaled Nitric Oxide Levels and Spirometry
Study Start Date : December 2009
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012



Primary Outcome Measures :
  1. Fraction of exhaled Nitric Oxide (FeNO) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Spirometry [ Time Frame: 1 year ]


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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01000272


Locations
Israel
"DANA" childrens hospitall
Tel Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Yakov Sivan, Associate Professor Tel Aviv Medical Center

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01000272     History of Changes
Other Study ID Numbers: TASMC-09-YS-439-CTIL
First Posted: October 23, 2009    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: October 2009

Additional relevant MeSH terms:
Inflammation
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis