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Can a Very High Result From a Screening Test for Celiac Disease be Used to Diagnose Celiac Disease?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00175760
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : April 12, 2011
Information provided by:
University of British Columbia

Brief Summary:
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.

Condition or disease Intervention/treatment
Celiac Disease Procedure: Diagnosis of Celiac Disease

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 100 participants
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
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Intervention Details:
  • Procedure: Diagnosis of Celiac Disease
    During GI endoscopy a minimum of 4 small intestinal biopsies will be taken from all subjects and controls.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Aged 2 months to 18 years with a planned upper GI endoscopy.

Inclusion Criteria:

Inclusion-All patients planned to undergo upper GI endoscopy with biopsies.

Exclusion Criteria:

Exclusion-refusal to participate, not planning to have biopsies performed with the endoscopy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00175760

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Canada, British Columbia
BC Children's Hospital
Vancouver, British Columbia, Canada, V5Z 1L8
Sponsors and Collaborators
University of British Columbia
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Principal Investigator: Dr. Collin Barker University of British Columbia

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Responsible Party: Dr. Collin Barker, University of British Columbia Identifier: NCT00175760    
Other Study ID Numbers: C04-0304
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: April 12, 2011
Last Verified: April 2011
Keywords provided by University of British Columbia:
comparison study
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases