Risk Stratification of Rapid Disease Progression in Children With Crohn's Disease

It is estimated that between 15-20% of children with Crohn's disease will develop
complications that can require surgery within the first three years of diagnosis. The purpose
of this study for children with a new diagnosis of Crohn's disease is to identify biomarkers
found in the blood or stool to help predict which children are at risk of developing
complications.

A total of 2000 children with newly-diagnosed Crohn's disease will be enrolled within 30 days
of diagnosis. Up to 28 medical sites in the United States and Canada will participate in the
study.

Inclusion Criteria:

- Males and females younger than 17 years of age (before their 17th birthday). An upper
limit of 17 years of age was selected as important inclusion criteria to maximize the
number of potential subjects that would be diagnosed and followed by a pediatric
gastroenterologist for at least 3 years.

- Confirmed or suspected diagnosis of Crohn's disease based on standardized diagnostic
criteria. The enrollment should occur within 30 days of diagnosis.

- Able to provide written informed consent or the ability to obtain written informed
consent from the parents or patient's legal guardian in conjunction with youth assent.

- Consented to have specimens tested for genetics and immune responses.

- Access to follow-up data for a minimum of 36 months after diagnosis.

- Final eligibility will be determined by the health professionals conducting this
clinical trial.

Exclusion Criteria:

- Infectious colitis.

- Final eligibility will be determined by the health professionals conducting this
clinical trial.