Clinical Evaluation of Three Celiac Disease-Specific Patient Reported Outcome Instruments in Established and Newly Diagnosed Celiac Disease Patients


Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

This is an evaluation of celiac-specific patient reported outcome instruments in celiac disease patients.

Who is eligible to participate?

Inclusion Criteria: - History of biopsy proven celiac disease - Adherence to a gluten-free diet (established patients only) - TG2 negative (established patients only) - TG2 positive (newly diagnosed patients only) - Signed informed consent Exclusion Criteria: - History of IgE-mediated reactions to gluten - Significant laboratory abnormalities - History of untreated or GI disease - Positive pregnancy test - Any medical condition which could adversely affect study participation

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