Respiratory Tract Inflammation in Children With Inflammatory Bowel Disease (IBD)
Recruitment status was Not yet recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- Fraction of exhaled Nitric Oxide (FeNO) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- 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) |
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 |
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
Inclusion Criteria:
4-18 years old children diagnosed with IBD:
- Histological diagnosis of Crohn's disease
- Histological diagnosis of Ulcerative colitis
- Negative stool cultures
Exclusion Criteria:
- Respiratory tract infection during the 6 weeks prior to enrollment
- Diagnosis of asthma
- Current treatment with steroids
- Smoking
Contacts and Locations 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 May 22, 2013