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 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
NCT ID:
NCT05209568
Eligibility Criteria:
Inclusion Criteria:
1. On a gluten-free diet for ≥ 4 weeks
2. Willing to consume gluten for research
3. For the celiac disease arm, diagnosis confirmed by serology and/or histology
Exclusion Criteria:
1. Pregnancy
2. Wheat allergy
3. Type 1 diabetes
4. BMI z-score \< -2
5. History of more than minimal symptoms following gluten exposure on a gluten-free diet
6. Comorbid condition that in the opinion of the investigator would interfere with study participation or would confound study results
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
101 Years
Study:
NCT05209568
Study Brief:
Protocol Section:
NCT05209568