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.

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Key information

Conditions

Celiac Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

2 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

BC Children's Hospital

Vancouver, British Columbia, V5Z 1L8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diagnosis of Celiac Disease

Procedure

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

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Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Important dates

Study start: 2004
Primary completion: 2006
Study completion: 2006
First posted: Sep 15, 2005
Registry last updated: Apr 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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