Risk Stratification and Identification of Immunogenetic and Microbial Markers of Rapid Disease Progression in Children with Crohn's Disease

Study ID
STU 062010-136

Cancer Related

Healthy Volunteers

Study Sites

  • Children’s Medical Center (Dallas, Plano, Southlake)

Melissa Irek

Principal Investigator
Ashish Patel, M.D.


The currently accepted pathogenic hypothesis for inflammatory bowel disease proposes the role of host genetics, specifically [Quote]pre-programmed[Quote] host immune responses, and environmental factors such as microbial triggers, including in particular, enteric flora, resulting in disease susceptibility, development, and eventual expression. These factors (host immune/inflammatory cells, intestinal epithelia and microbial flora) and their interactions may also be important determinants of disease phenotype and disease progression. Therefore, we hypothesize that there are identifiable immunologic, genetic, enteric flora profiles along with clinical risk factors that influence the disease onset and phenotype, as well as the natural history of pediatric CD.
aim 1: To identify demographic, clinical, microbial (i.e., fecal stream characterization), genetic, and/or immunologic risk factors that influence the likelihood of the rapid development of complicated disease phenotypes manifested as, penetrating disease, stricturing disease and need for surgery in children with newly diagnosed CD. The newly formed Pediatric iBD north american Collaborative Research Group (PiBD naCRG) will utilize the existing participating centers in the four current consortia and recruit additional centers to enroll newly diagnosed uncomplicated (nonpenetrating-nonstricturing) pediatric CD patients.
aim 2: Develop and validate risk stratification by stratifying patients into different levels of risk at diagnosis based on clinical, demographic, host microbial ecology, immune and genetic determinants identified in aim 1. The risk stratification will be completed by state-of-the-art analysis using logistic regression and mathematical modeling among the different risk groups of pediatric CD patients followed over a minimum of 60 month period. Time to complication as defined by time to stricture or time to internal penetration will be included in the analysis.

Participant Eligibility

1. Males and females [?] 16 years of age.
2. A confirmed or suspected diagnosis of CD based on standardized diagnostic criteria. The enrollment visit should occur within 30 days of diagnosis.
3. Able to provide written informed consent.
4. Have consented to have specimens tested for genetics and immune responses.
5. Access to follow up data for a minimum of 60 months after diagnosis

An upper limit of 16 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.