A Decentralized Home-Based Study To Investigate Novel Objective Biomarker Of Gluten-Mediated Symptoms In Celiac Disease Participants (CeDar ROSE Study)
- Conditions
- Celiac Disease
- Registration Number
- NCT05686369
- Lead Sponsor
- Chugai Pharmaceutical
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
[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)
[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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The concordance between the novel digital biomarker and the presence of celiac disease-related symptoms up to 13 weeks
- Secondary Outcome Measures
Name Time Method Adverse events up to 13 weeks Incidence and severity of adverse events
Safety as assessed by Electrocardiograms (heart rate) up to 13 weeks Abnormality in heart rate
The scores of Celiac Disease-related Quality of Life (CDQOL) up to 13 weeks Scoring rate for quality of life in celiac disease participants Minimum: 1 (total disagreement) Maximum: 5 (total agreement)
Safety as assessed by respiratory rate up to 13 weeks Abnormality in respiratory rate
Safety as assessed by blood chemistry test with measuring chemicals up to 13 weeks Incidence of blood chemistry abnormalities
Safety as assessed by systolic and diastolic by blood pressure up to 13 weeks Abnormality in blood pressure
Safety as assessed by urinalysis test with examining the visual, chemical and microscopic aspects up to 13 weeks Incidence of urinalysis abnormalities
Adverse events' relationship to gluten exposure up to 13 weeks Incidence and severity of adverse events' relationship to gluten exposure
Safety as assessed by pulse rate up to 13 weeks Abnormality in pulse rate
Correlations between the comprehensive measurement and the scores of patient reported outcomes up to 13 weeks Correlations between the comprehensive measurement and the scores of Celiac Disease Symptom Diary (CDSD), 36-Item Short Form Survey (SF-36), or Celiac Disease-related Quality of Life (CDQOL)
The comprehensive measurement up to 13 weeks The comprehensive measurement objectively evaluated by wearable biosensor
The scores of Celiac Disease Symptom Diary (CDSD) up to 13 weeks Scoring rate for celiac disease symptoms Minimum: Non Maximum: Very severe
The scores of Short Form 36 (SF-36) up to 13 weeks Scoring rate for quality of life (higher score-better quality of life) Minimum: 0 Maximum: 100
Safety as assessed by body temperature up to 13 weeks Abnormality in body temperature
Safety as assessed by percutaneous oxygen saturation up to 13 weeks Abnormality in percutaneous oxygen saturation
Safety as assessed by hematology test with counting blood cells up to 13 weeks Incidence of hematology abnormalities
3072 Blood biomarkers profile up to 13 weeks 3072 Blood biomarkers profile measured by proteomics in well-controlled celiac disease participants (Cohort A) and in celiac disease participants with persistent symptoms (Cohort B)
Safety as assessed by coagulation testing with thrombolytic capacity measurement up to 13 weeks Incidence of coagulation abnormalities
Safety as assessed by Electrocardiograms (QT interval) up to 13 weeks Abnormality in QT interval
The incidence of novel digital biomarker (Cohort B only) up to 13 weeks The incidence of novel digital biomarker established in Cohort A (Cohort B only)
Celiac disease serology levels up to 13 weeks Serology levels about Deamidated gliadin peptide-IgA (DGP-IgA; unit), and deamidated gliadin peptide-IgG (DGP-IgG; unit)
48 Blood biomarker profile up to 13 weeks 48 Blood biomarkers profile measured by proteomics in well-controlled celiac disease participants (Cohort A) and in celiac disease participants with persistent symptoms (Cohort B)
Change from baseline in 3072 blood biomarkers profile (Cohort A only) up to 13 weeks Change from baseline in 3072 blood biomarker profile measured by proteomics after gluten/sham gluten challenge (Cohort A only)
Change from baseline in 48 blood biomarkers profile (Cohort A only) up to 13 weeks Change from baseline in 48 blood biomarkers profile measured by proteomics after gluten/sham gluten challenge (Cohort A only)
Trial Locations
- Locations (1)
Science 37
🇺🇸Culver City, California, United States