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
1 other identifier
observational
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2009
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2009
CompletedFirst Posted
Study publicly available on registry
October 23, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedJune 26, 2014
October 1, 2009
2.8 years
October 20, 2009
June 25, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Fraction of exhaled Nitric Oxide (FeNO)
1 year
Secondary Outcomes (1)
Spirometry
1 year
Eligibility Criteria
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
You may qualify if:
- years old children diagnosed with IBD:
- Histological diagnosis of Crohn's disease
- Histological diagnosis of Ulcerative colitis
- Negative stool cultures
You may not qualify if:
- Respiratory tract infection during the 6 weeks prior to enrollment
- Diagnosis of asthma
- Current treatment with steroids
- Smoking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
"DANA" childrens hospitall
Tel Aviv, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yakov Sivan, Associate Professor
Tel Aviv Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2009
First Posted
October 23, 2009
Study Start
December 1, 2009
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
June 26, 2014
Record last verified: 2009-10