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Completed

NCT Number: NCT01297907

Bronchial Hyperreactivity in Children With Crohn Disease

Background: Latent pulmonary involvement is described in Crohn Disease(CD). Bronchial hyperreactivity measured by the Methacholine Challenge Test (MCT) has been evaluated in two studies involving mainly adults.Our aim was to determine the frequency of bronchial hyperreactivity in pediatric patients followed and treated for Crohn disease.

Methods: Twenty-three children with Crohn disease completed a questionnaire, followed by spirometry, Methacholine Challenge Test (MCT) and determination of Fractional Exhaled NO (FENO). The control group included patients evaluated for functional cough who had negative Methacholine Challenge Test (MCT).

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

6 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rambam Medical Center

Haifa, 32000, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children with Crohn disease
  • Children that can perform lung function tests (MCT)

Exclusion criteria

  • Upper respiratory tract infection last month
  • Fever or Pneumonia last month
  • Smoking
  • Other chronic diseases
  • Other respiratory diseases

Treatment and study plan

Methacholine Challenge Test

Other

Methacholine challenge test to evaluate airway hyperreactivity

Fractional Exhaled NO (FENO)

Other

Fractional Exhaled NO to evaluate eosinophilic inflammation

Blood Test

Other

Blood Tests (Eosinophil Count)

PCDAI

Other

Clinical Evaluation for Pediatric Crohn's Disease Activity Index (PCDAI)

Primary outcomes

  1. Methacholine challenge test

    Time frame: 18 months

    As assessed by methacholine challenge test with determination of PC20.

Secondary outcomes

  1. Fractional Exhaled NO

    Time frame: Day 1

    Exhaled NO test

  2. Eosinophils count

    Time frame: Day 1

    blood test

  3. Pediatric Crohn's Disease Activity Index (PCDAI)

    Time frame: Day 1

    Clinical Evaluation

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 17, 2011
Registry last updated
Feb 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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