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

NCT ID: NCT00175760

Last Updated: 2011-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-12-31

Study Completion Date

2006-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Celiac Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Diagnosis of Celiac Disease

During GI endoscopy a minimum of 4 small intestinal biopsies will be taken from all subjects and controls.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

2 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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University of British Columbia

Principal Investigators

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Dr. Collin Barker

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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BC Children's Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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C04-0304

Identifier Type: -

Identifier Source: org_study_id

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