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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01000272
First received: October 20, 2009
Last updated: October 22, 2009
Last verified: October 2009
  Purpose

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
Inflammatory Bowel Disease

Study Type: Observational
Study Design: 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

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Fraction of exhaled Nitric Oxide (FeNO) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Spirometry [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2009
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   4 Years to 18 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Name/Official Title: Yakov Sivan, Tel Aviv Sourasky Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01000272     History of Changes
Other Study ID Numbers: TASMC-09-YS-439-CTIL
Study First Received: October 20, 2009
Last Updated: October 22, 2009
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on April 15, 2014