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NCT00175760 Clinical Trial

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

Celiac Disease Clinical Trial

Official title:
Prospective Assessment of High Titre TTG to Diagnose Celiac Disease in Select Paediatric Patients.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00175760
Other study ID # C04-0304
Secondary ID
Status Completed
Phase N/A
First received September 13, 2005
Last updated April 11, 2011
Start date December 2004
Est. completion date October 2006

Study information
Verified date April 2011
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date October 2006
Est. primary completion date October 2006
Accepts healthy volunteers No
Gender Both
Age group 2 Months to 18 Years
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Canada BC Children's Hospital Vancouver British Columbia

Sponsors (1)
Lead Sponsor Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

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