Crohn’s Disease - Risk and Microbial Marker Study

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

Protocol Description

The purpose of this study is to identify “bio-markers” easily found in blood, stool or in the lining of the intestines that can help doctors understand which children with Crohn’s Disease are at risk of developing complications quickly, enabling them to better treat patients.

Eligibility Criteria

Subject to certain exclusion criteria, boys and girls up to age 16 who have newly diagnosed or suspected inflammatory bowel disease (IBD), also known as Crohn’s disease, ulcerative colitis or indeterminate colitis, will be asked to participate in the study.
Males: Up to age 16
Females: Up to age 16


During the initial visit, researchers will collect medical history information as well as blood and stool samples for analysis. Blood draws will also be done at the 3 annual follow-up visits. For patients scheduled for a routine colonoscopy with biopsy, there is a study option to collect a few additional biopsies for research purposes.
Visits: 4
Duration: 3 years

Note: Study participants are also eligible to enroll in the Crohn’s and Colitis Foundation of America Partners Kids & Teens Linkage Project, an online study of young patients that provides feedback related to quality of life issues. Participants will be asked to update their medical information twice a year and will receive quarterly progress reports about IBD.

Status: Closed to Enrollment

Source(s) of Support

Crohn’s and Colitis Foundation of America

Primary Investigator

David J. Keljo, MD, PhD

Contact Information

For more information about this study or enrollment, please contact:
Kathleen Calabro RN, BSN