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:
NCT05686369
Eligibility Criteria:
Inclusion Criteria:
\[Cohort A and B\]
* History of medically diagnosed celiac disease based on biopsies and positive celiac serology.
* Be on a GFD for at least 12 months
* Willing and able to adhere to use and management of the wearable device
* Willingness to comply with home-based approach and visits by a HN professional \[Cohort A only\]
* Experienced at most mild symptoms of celiac disease
* Willingness to consume food containing up to 6 g of gluten protein per challenge day and up to 18 g of gluten protein in total during the study \[Cohort B only\]
* Experienced at least 2 different gluten-related symptoms (e.g., diarrhea, abdominal pain, bloating, nausea, tiredness) or 1 gluten-related symptom occurred twice within the month before screening, and at screening were required to have a qualifying score as moderate or severe on at least one symptom on the CDSD in the 14 days recording period.
* Positive for any of the 3 serology tests, tissue - transglutaminase-2-IgA \[tTG2-IgA\] (≥4 U/mL), deamidated gliadin peptide-IgA \[DGP-IgA\] (≥20 U/mL), or deamidated gliadin peptide-IgG \[DGP-IgG\] (≥20U/mL)
Exclusion Criteria:
\[Cohort A and B\] Refractory celiac disease \[Cohort A\] Positive for any of the 3 serology tests
* Tissue transglutaminase-2 \[tTG2-IgA\] (≥10 U/mL; normal range: 0-3.99 U/mL) prior to the observation period, but weak positive (4-10 U/mL) can be enrolled in this study.
* Deamidated gliadin peptide-IgA \[DGP-IgA\], and deamidated gliadin peptide-IgG \[DGP-IgG\] prior to the observation period, but weak positive (20-30 U/mL) can be enrolled.
History of IgE-mediated reactions to wheat, barley, rye, or other ingredients in the gluten products used in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05686369
Study Brief:
Protocol Section:
NCT05686369