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

NCT ID: NCT01000272

Last Updated: 2014-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-10-31

Brief Summary

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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

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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.

Conditions

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Inflammatory Bowel Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yakov Sivan, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv Medical Center

Locations

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"DANA" childrens hospitall

Tel Aviv, , Israel

Site Status

Countries

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Israel

Other Identifiers

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TASMC-09-YS-439-CTIL

Identifier Type: -

Identifier Source: org_study_id

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