The growth retardation and outcomes with therapy (growth) study: A prospective evaluation in pediatric Crohn*s disease

Crohn's disease (CD) is a chronic inflammatory disorder of the gastrointestinal
tract that can affect both children and adults, of unknown etiology. The course
of the disease is characterized by periods of remission and relapse, or
continuous clinical symptoms. Disease activity is characterized (upon
histopathology) by transmural inflammation of the gut, most typically in the
ileum or colon, though it may involve any section of the gut. Clinically, this
inflammation may lead to abdominal pain, diarrhea, rectal bleeding, weight loss
and decreased growth velocity, as well as a myriad of other symptoms.
Complications may include growth failure, perianal disease, strictures,
internal fistulae or abscesses, and may require surgery in close to 50% of
patients over time.

Identifying subsets of Crohn's disease (CD) at risk for poor outcomes is a
priority in pediatric CD research. Having the ability to predict patients more
likely to relapse, to be refractory to therapy or to develop complications may
enable physicians to treat these subsets more aggressively at disease onset, or
early in the course of the disease, without exposing all pediatric patients to
medications that increase the risk for neoplasia, and not to wait for
complications before instituting more aggressive maintenance therapy. There are
no prospective studies that have evaluated this issue in new onset, treatment
naïve pediatric CD.

The "Growth study" is an observational, prospective, inetrnational multicenter
study.

Patients included in this study will not have any risks since no interventions
take place. The burden is minimal since the standardized visits are combined
with the regular visits. Drawing of blood also will be combined with the
regular blood drawings.