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
Last updated: 05/22/2013
NCT ID: NCT01560169
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