Prospective Study of Undiagnosed Celiac Disease
Direct benefits to the participants, who are diagnosed with celiac disease may be substantial and could include lessening or prevention of GI symptoms, correction of biochemical abnormalities and reduction in risk for malignancies or bone disease which are most common in untreated celiac disease. However, the precise benefit is unknown and the motivation for this proposed study. If these individuals have a positive celiac serology test at the present time there is a high likelihood that they may have celiac disease.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Epidemiology of Celiac Disease: A Prospective Study of Undiagnosed Celiac Disease in the Community|
- Understanding the impact of undiagnosed celiac disease and the potential benefits of diagnosis [ Time Frame: one year ] [ Designated as safety issue: No ]To understanding the impact of undiagnosed celiac disease and the potential benefits, detection and treatment may have a substantial impact on the health of these subjects and the large numbers of Americans with undiagnosed celiac disease. The outcome measures we will be looking at are Quality of Life, GI Symptoms including diarrhea, constipation, abdominal pain, Tissue Transglutaminase level improvement after 12 weeks on a gluten free diet, bone density, understanding of a gluten free diet.
|Study Start Date:||July 2010|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
|Experimental: Dietary instruction on Gluten Free Diet||
Other: Dietary instruction
Subjects subsequently diagnosed with celiac disease will have gluten-free diet instructions given by registered dietitian experienced in the gluten-free diet. Subjects will have follow-up in 3 months time from initial instruction to verify compliance.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01317914
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Joseph Murray, MD||Mayo Clinic|