- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00175760
Can a Very High Result From a Screening Test for Celiac Disease be Used to Diagnose Celiac Disease?
April 11, 2011 updated by: University of British Columbia
Prospective Assessment of High Titre TTG to Diagnose Celiac Disease in Select Paediatric Patients.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1L8
- BC Children's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 months to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Aged 2 months to 18 years with a planned upper GI endoscopy.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dr. Collin Barker, University of British Columbia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2004
Primary Completion (Actual)
October 1, 2006
Study Completion (Actual)
October 1, 2006
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Estimate)
April 12, 2011
Last Update Submitted That Met QC Criteria
April 11, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C04-0304
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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