Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT01560169
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01560169
Study Brief:
Protocol Section:
NCT01560169