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

This study has been completed.
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00175760
First received: September 13, 2005
Last updated: April 11, 2011
Last verified: April 2011
  Purpose

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 Intervention
Celiac Disease
Procedure: Diagnosis of Celiac Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Assessment of High Titre TTG to Diagnose Celiac Disease in Select Paediatric Patients.

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Estimated Enrollment: 100
Study Start Date: December 2004
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Ages Eligible for Study:   2 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Aged 2 months to 18 years with a planned upper GI endoscopy.

Criteria

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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175760

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

No publications provided

Responsible Party: Dr. Collin Barker, University of British Columbia
ClinicalTrials.gov Identifier: NCT00175760     History of Changes
Other Study ID Numbers: C04-0304
Study First Received: September 13, 2005
Last Updated: April 11, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
TTG
pediatric
comparison study

Additional relevant MeSH terms:
Celiac Disease
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Malabsorption Syndromes
Metabolic Diseases

ClinicalTrials.gov processed this record on October 29, 2014