A Decentralized Home-Based Study To Investigate Novel Objective Biomarker Of Gluten-Mediated Symptoms In Celiac Disease Participants (CeDar ROSE Study)

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