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

Study Purpose

This is a decentralized study to primarily explore a novel objective digital biomarker (i.e., Gluten Dependency Index) for celiac disease-related responses triggered by gluten exposure using a wearable biosensor. This study also explores a novel objective blood biomarker specific to celiac disease activity and evaluates participant symptoms, lifestyle and an objective comprehensive measurement (e.g., activity, stress and sleep) in celiac disease participants. 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Chugai Pharmaceutical
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Sponsor Chugai Pharmaceutical Co. Ltd
Principal Investigator Affiliation clinical-trials@chugai-pharm.co.jp
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Celiac Disease
Arms & Interventions


: Cohort A: Well-controlled Celiac Disease

Cohort A: Well-controlled celiac disease participants who should be asymptomatic or mildly symptomatic

: 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


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Science 37, Culver City, California




Science 37

Culver City, California, 90230

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