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Growth Relapse and Outcomes With Therapy 1 (GROWTH1)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2008 by European Society of Pediatric Gastroenterology, Hepatology and Nutrition.
Recruitment status was:  Recruiting
Information provided by:
European Society of Pediatric Gastroenterology, Hepatology and Nutrition Identifier:
First received: July 7, 2008
Last updated: July 8, 2008
Last verified: July 2008
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.

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

Resource links provided by NLM:

Further study details as provided by European Society of Pediatric Gastroenterology, Hepatology and Nutrition:

Biospecimen Retention:   Samples Without DNA
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


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00711945

Wolfson Medical center Recruiting
Holon, Israel, 58100
Contact: Arie Levine    97235028808   
Sponsors and Collaborators
European Society of Pediatric Gastroenterology, Hepatology and Nutrition
  More Information

Responsible Party: Arie Levine, IBD Working Group, ESPGHAN Identifier: NCT00711945     History of Changes
Other Study ID Numbers: GROWTH1
Study First Received: July 7, 2008
Last Updated: July 8, 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 processed this record on May 25, 2017