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Growth Relapse and Outcomes With Therapy 1 (GROWTH1)

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ClinicalTrials.gov Identifier: NCT00711945
Recruitment Status : Unknown
Verified July 2008 by European Society of Pediatric Gastroenterology, Hepatology and Nutrition.
Recruitment status was:  Recruiting
First Posted : July 9, 2008
Last Update Posted : July 9, 2008
Information provided by:

Study Description
Brief Summary:
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 or disease
Crohn's Disease Pediatric Onset

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Growth Relapse and Outcomes With Therapy 1:Factors Determining Poor Outcomes in Pediatric Crohn"s Disease
Study Start Date : March 2008
Estimated Primary Completion Date : October 2010
Estimated Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Biospecimen Retention:   Samples Without DNA
Serum for antiglycan antibodies stool for calprotectin

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00711945

Wolfson Medical center Recruiting
Holon, Israel, 58100
Contact: Arie Levine    97235028808    alevine@wolfson.health.gov.il   
Sponsors and Collaborators
European Society of Pediatric Gastroenterology, Hepatology and Nutrition
More Information

Responsible Party: Arie Levine, IBD Working Group, ESPGHAN
ClinicalTrials.gov Identifier: NCT00711945     History of Changes
Other Study ID Numbers: GROWTH1
First Posted: July 9, 2008    Key Record Dates
Last Update Posted: July 9, 2008
Last Verified: July 2008

Keywords provided by European Society of Pediatric Gastroenterology, Hepatology and Nutrition:
Crohn's disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes