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 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
NCT ID:
NCT01902368
Eligibility Criteria:
Inclusion Criteria:
* Be ambulatory, community dwelling, 18 to 80 years, inclusive
* For the screening cohort:
* Have a first or second degree family member with known biopsy-proven celiac disease.
* Have not been on a gluten-free diet in the past 6 months
* Have not received a prior diagnosis of celiac disease at any time
* For the clinically detected cohort
* Have biopsy proven celiac disease detected based on clinical symptoms and on a gluten free diet for less than 1 month.
Exclusion Criteria:
* For the screen detected cohort, have significantly severe symptoms (as judged by the investigator) at screening which preclude randomization;
* Be on a gluten-free diet or have been on a gluten-free diet within the past 6 months.
* Be pregnant or planning pregnancy in the study time period
* Be taking corticosteroids or immunomodulators
* Have a history of significant concomitant gastrointestinal disease or other comorbidity judged by the investigator to potentially interfere with study outcomes
* Be unable or unwilling to cooperate with the study protocol
* Have insufficient knowledge of English to complete study surveys
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01902368
Study Brief:
Protocol Section:
NCT01902368