Evaluation of Patient Reported Outcome Instruments in Celiac Disease Patients

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

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

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