Can a Very High Result From a Screening Test for Celiac Disease be Used to Diagnose Celiac Disease?
This study is to see if a high response to the TTG screening test for celiac disease is as accurate as the current method of diagnosing celiac disease which entails a general anesthetic and upper endoscopy to obtain biopsies of the small intestine. If the screening blood test is highly accurate, then some patients that are being evaluated for celiac disease may not require an upper GI endoscopy and can be treated more quickly. If they respond to the therapy then they will be deemed to have celiac disease.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Prospective Assessment of High Titre TTG to Diagnose Celiac Disease in Select Paediatric Patients.|
|Study Start Date:||December 2004|
|Study Completion Date:||October 2006|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
Procedure: Diagnosis of Celiac Disease
All patients scheduled for upper GI endoscopy will be approached for recruitment into the study. A minimum of 4 small intestinal biopsies will be taken from all subjects and controls. All TTG specimens will be run through the hospital laboratory. Intermediate level TTG values 20-100 will be assessed separately and as part of the larger group. An optional part B of the study will assess the frequency of lactose intolerance in subjects prior to the start of a gluten free diet.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00175760
|Canada, British Columbia|
|BC Children's Hospital|
|Vancouver, British Columbia, Canada, V5Z 1L8|
|Principal Investigator:||Dr. Collin Barker||University of British Columbia|