Crohn’s Disease Biomarker Study: The GEM Project

Study on the Genetic, Environmental and Microbial Interactions that Cause IBD (GEM Project)

Protocol Description

Through this international study, researchers hope to learn more about the causes of Crohn’s disease by investigating potential reasons why some family members develop the disease and others do not. First-degree relatives with Crohn’s appear to be at higher risk compared to the general population. The GEM Project explores possible causes for Crohn’s disease by studying genetic, environmental and microbial (GEM) factors in healthy individuals with parents or siblings who have Crohn’s disease.

Eligibility Criteria

Subject to certain exclusion criteria, the study is accepting patients of all ages of both genders, who have a confirmed diagnosis of Crohn’s disease and who have a healthy full sibling between the ages of 6 and 35 at the time of enrollment. Researchers will invite full siblings, who are currently unaffected by Crohn’s, to participate and be followed over time to see if they develop Crohn’s disease.
Males and Females: All ages for those with Crohn’s disease and ages 6 through 35 for full sibling participants.

Requirements

During the initial study visit, researchers will gather information on the patient diagnosed with Crohn’s disease including medical history, treatments and family background. Unaffected siblings who participate will return for an initial study visit to provide researchers information about medical history, diet, family background, etc., as well as blood, urine, and stool samples. Siblings will be contacted every 6 months for up to 5 years to check on health status and whether they are experiencing any symptoms of Crohn’s disease.
Visits: 2
Duration: up to 5 years

Status: Open to Enrollment

Source(s) of Support

Crohn’s & Colitis Foundation of Canada

Primary Investigator

David Keljo, MD

Contact Information

For more information about the study or enrollment, please contact:
Amy Bookser, RN
412-692-8453
or
Kathleen Calabro, RN, BSN
412-692-6092