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Division of Gastroenterology, Hepatology and Nutrition Prospective Study Of Serologic Markers In The Diagnosis Of Childhood Celiac Disease

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Principal Investigators: Alan Leichtner, MD, FAAP and Dascha Weir, MD

Department: Gastroenterology

Protocol Status: Recruitment Complete

Trial Description: Early diagnosis of celiac disease may prevent complications of untreated disease including increased risk of specific cancers and other autoimmune diseases. Cases are initially identified based on clinical assessment and a serological test, antibody to human recombinant tissue transglutaminase IgA (TTG IgA), and are further confirmed through duodenal biopsy, which constitutes the gold standard test for celiac disease. Although TTG is a highly sensitive and specific test, it performs less well in the pediatric population, particularly in patients under the age of 2 years. A second test, IgA endomysial antibodies (EMA IgA) performs similarly to TTG, although the serologic test is expensive and heavily operator dependent.Newly developed antibody assays using synthetic deamidated gliadin-related peptides as target antigens (AGA II IgA, AGA II IgG and DGP) have shown promise for identification of celiac disease in adults and may have better sensitivity and specificity than TTG. Newly developed assays using intestinal fatty acid binding proteins (I-FABP) and serum mucosal addressin cell adhesion molecule 1 (sMAdCAM-1) have been potentially shown to indicate the extent of intestinal damage and may be predictive of celiac disease. This study aims to assess the accuracy of AGA II , DGP, FABP-I and sMAdCAM-1 to diagnose celiac disease in children. As a secondary aim, we are also interested in exploring the relationship between immunoglobulin TTG IgA and IgG subtypes with symptoms and extent of villous damage in pediatric patients with celiac disease.

Study procedures: Biopsy and serology data is extracted through chart review.  Parents and patient (if appropriate) will complete a self-administered survey to predict adherence to gluten-free diet.  Medical Record Reviews are completed after 6 months and after 3 years of enrollment.

Recruitment Info: Subjects older than 6 months and less than or equal to 18 years of age.  Subjects must have been seen by a GI provider in the Children’s Hospital Gastroenterology Program and referred for EGD to confirm a possible diagnosis of Celiac Disease (as determined either by clinical presentation, serology or both) with EGD and biopsies. Subjects with known diagnosis of celiac disease or who have initiated a gluten-free diet for greater than 2 weeks within the past 2 months may not participate.

Recruitment Contact Name: Caitlin McCarty

Recruitment Contact Phone: 617-355-8881

Recruitment Contact Email: caitlin.mccarty@childrens.harvard.edu

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