Prospective Study of Undiagnosed Celiac Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01317914
Recruitment Status : Completed
First Posted : March 17, 2011
Last Update Posted : October 2, 2017
Information provided by (Responsible Party):
Joseph A. Murray, M.D., Mayo Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Celiac Disease Other: Dietary instruction Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Epidemiology of Celiac Disease: A Prospective Study of Undiagnosed Celiac Disease in the Community
Study Start Date : July 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease
U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Understanding the impact of undiagnosed celiac disease and the potential benefits of diagnosis [ Time Frame: one year ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • At least 60 years old
  • Male and female

Retrospective testing for celiac disease was done on previously stored serum. Contacting specific individuals for inclusion into study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01317914

United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Joseph Murray, MD Mayo Clinic

Responsible Party: Joseph A. Murray, M.D., Professor of Medicine, Mayo Clinic Identifier: NCT01317914     History of Changes
Other Study ID Numbers: 10-000178
First Posted: March 17, 2011    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017

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