A Decentralized Home-Based Study To Investigate Novel Objective Biomarker Of Gluten-Mediated Symptoms In Celiac Disease Participants (CeDar ROSE Study)
NCT ID: NCT05686369
Last Updated: 2023-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
12 participants
OBSERVATIONAL
2023-03-08
2023-10-05
Brief Summary
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Approximately 170 well-controlled celiac disease participants (Cohort A) and 40 celiac disease participants with persistent symptoms (Cohort B) will be monitored for 13 and 8 weeks in the observation period, respectively, in a home-based setting using the wearable biosensor along with a mobile platform including some electronic questionnaires.
The wearable biosensor continuously records biosensor data. These data will be used to develop a new algorithm for Gluten Dependency Index and calculate the Gluten Dependency Index, Activity Value, Stress Value, or Sleep Time. Participants will report celiac disease-related symptoms, diet (including any accidental gluten exposures), exercise, menstruation questionnaires in CDSD and mobile platform questionnaire (MPFQ), which is originally designed by the Sponsor.
All participants both in Cohort A and B are required to maintain gluten-free diet throughout the study. Only participant who are enrolled in Cohort A will be required gluten challenge.
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Cohort A: Well-controlled Celiac Disease
Cohort A: Well-controlled celiac disease participants who should be asymptomatic or mildly symptomatic
No interventions assigned to this group
Cohort B: Non-Responsive Celiac Disease
Cohort B: Celiac disease participants with persistent symptoms who are known to be symptomatic and show positivity to serum auto-antibodies even though participants have been adhering to gluten-free diet
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Chugai Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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Science 37
Culver City, California, United States
Countries
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Other Identifiers
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DQB002UZ
Identifier Type: -
Identifier Source: org_study_id
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