Growth Relapse and Outcomes With Therapy 1 (GROWTH1)
Recruitment status was Recruiting
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Purpose
Pediatric Crohn's Disease is a life long disease , presenting early in life.As such , it is imperative to be able to evaluate the risk for more severe disease and poorer outcomes when making the decision which therapies to offer our patients. These decisions should be based according to longer-term disease outcomes, such as whether they prevent disease relapse or prolong remission [10-12]. However, for the most part, previous studies were not designed to yield predictive parameters that could allow a clinician to differentiate which patients are at a higher risk for relapse, or more likely to to have serious attacks or complications of the disease or therapy. The ability to predict these risks would impact dramatically the way CD patients are treated, allowing the clinician to tailor therapy, both type and intensity, to each patient's individual risk for relapse and outcomes.In the present first phase of the study , we will attempt to identify factors that predict relapse of the disease, focusing on the use of calprotectin at onset and after clinical remission, and on the use of anti-glycan antibodies, as well as disease severity, site and phenotype.
| Condition |
|---|
|
Crohn's Disease Pediatric Onset |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Growth Relapse and Outcomes With Therapy 1:Factors Determining Poor Outcomes in Pediatric Crohn"s Disease |
Serum for antiglycan antibodies stool for calprotectin
| Estimated Enrollment: | 300 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
New onset pediatric Crohn's disease until and including age 18
Inclusion Criteria:
- Age 0-18
- New onset Crohn's disease
- Treatment naive
- Ileocolonoscopy +radiology
Exclusion Criteria:
- Prior Treatment
Contacts and Locations| Israel | |
| Wolfson Medical center | Recruiting |
| Holon, Israel, 58100 | |
| Contact: Arie Levine 97235028808 alevine@wolfson.health.gov.il | |
More Information
No publications provided
| Responsible Party: | Arie Levine, IBD Working Group, ESPGHAN |
| ClinicalTrials.gov Identifier: | NCT00711945 History of Changes |
| Other Study ID Numbers: | GROWTH1 |
| Study First Received: | July 7, 2008 |
| Last Updated: | July 8, 2008 |
| Health Authority: | Israel: Ministry of Health Finland: Ethics Committee Israel: Ethics Commission |
Keywords provided by European Society of Pediatric Gastroenterology, Hepatology and Nutrition:
|
Crohn's disease Relapse outcomes growth |
Additional relevant MeSH terms:
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on June 18, 2013