Status:
TERMINATED
Celiac Disease Screening
Lead Sponsor:
Beth Israel Deaconess Medical Center
Conditions:
Celiac Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this study is to see if it makes sense to test people for celiac disease who have a first or second degree relative (parent, sibling, child, grandparent, aunt or uncle) with celiac dise...
Detailed Description
Our overall hypothesis is that first and second degree relatives of individuals with celiac disease benefit from screening and diagnosis of celiac disease. Secondary hypotheses are: 1. The number nee...
Eligibility Criteria
Inclusion
- Be ambulatory, community dwelling, 18 to 80 years, inclusive
- For the screening cohort:
- Have a first or second degree family member with known biopsy-proven celiac disease.
- Have not been on a gluten-free diet in the past 6 months
- Have not received a prior diagnosis of celiac disease at any time
- For the clinically detected cohort
- Have biopsy proven celiac disease detected based on clinical symptoms and on a gluten free diet for less than 1 month.
Exclusion
- For the screen detected cohort, have significantly severe symptoms (as judged by the investigator) at screening which preclude randomization;
- Be on a gluten-free diet or have been on a gluten-free diet within the past 6 months.
- Be pregnant or planning pregnancy in the study time period
- Be taking corticosteroids or immunomodulators
- Have a history of significant concomitant gastrointestinal disease or other comorbidity judged by the investigator to potentially interfere with study outcomes
- Be unable or unwilling to cooperate with the study protocol
- Have insufficient knowledge of English to complete study surveys
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01902368
Start Date
September 1 2013
End Date
August 1 2014
Last Update
March 19 2018
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215