Prospective Study of Undiagnosed Celiac Disease

Celiac Disease Clinical Trial

Official title:

Epidemiology of Celiac Disease: A Prospective Study of Undiagnosed Celiac Disease in the Community

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01317914
• Other study ID #: 10-000178
• Status: Completed
• Phase: N/A
• First received: September 23, 2010
• Last updated: September 28, 2017
• Start date: July 2010
• Est. completion date: April 2012

Study information

• Verified date: September 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Celiac Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Understanding the impact of undiagnosed celiac disease and the potential benefits of diagnosis	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.	one year