The following was written by one of the CEDAR staff, Stephanie Tudor - TudorS@jove.uchsc.edu. Anyone with further questions should contact her directly. If you live in Denver and are biopsy-confirmed, they would love to hear from you.
The goals of this study are primarily to investigate the genetic and environmental causes of celiac disease, through the determination of the prevalence of anti-endomysial antibodies (EMA) in children considered to be at risk based on their family history (first degree relative) of either diabetes mellitus (Type I) or celiac disease or based on their HLA genotype (DR3) that is suspected to put them at an increased risk. The study is anticipating an enrollment of approximately 3,000 eligible children under the age of ten years. Most of the children reside in the Denver metro area, and a large proportion (approximately 40%) of the children involved with this research are concurrently enrolled in the Diabetes Autoimmunity Study in the Young (DAISY), which is run by the same principal investigator. The DAISY project is evaluating the presence of autoimmunity in relation to a pre-diabetic (insulin dependent diabetes mellitus) condition.
The enrolled subjects are screened initially between the ages of two and five years of age with a serum sample tested using an IgA-based anti-endomysial antibody assay. The serum samples are also screened for IgA levels in order to rule out the potential for false negative results in IgA deficient children. For the subjects who are tested at a positive titration, follow-up includes a clinic evaluation and small bowel biopsy at the Pediatric Gastroenterology Department at the Childrens Hospital of Denver, Colorado. If a diagnosis of celiac is made, the subject is referred for nutritional counseling and follow-up serum testing is done six months after the diagnosis to confirm effective treatment. Dietary factors are also collected upon enrollment of the subjects, reflecting dietary changes that are made between the ages of one and two years of age, as the introduction of gluten into the diet usually occurs in this time frame. Information on family history of other autoimmune conditions is also collected. Subjects who test negative for the presence of anti-endomysial antibodies will be re-screened two years after their initial testing, to verify their immune status with respect to the anti-endomysial antibodies.
By the end of the study period, we hope to have data that more accurately defines the prevalence of celiac disease in a United States population. The children recruited based on their HLA type are from a general population screening, and their data should be able to provide more accurate statistics on prevalence, and perhaps incidence, as some of these children have been followed since birth. We also hope to have identify associations with potential environmental exposures which may increase susceptibility to celiac disease.