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