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

Chugai Pharmaceutical12 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Celiac Disease

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The concordance between the novel digital biomarker and the presence of celiac disease-related symptoms

Time frame: up to 13 weeks

Secondary Outcomes

Correlations between the comprehensive measurement and the scores of patient reported outcomes

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)

Time frame: up to 13 weeks

The comprehensive measurement

The comprehensive measurement objectively evaluated by wearable biosensor

Time frame: up to 13 weeks

The scores of Celiac Disease Symptom Diary (CDSD)

Scoring rate for celiac disease symptoms Minimum: Non Maximum: Very severe

Time frame: up to 13 weeks

The scores of Short Form 36 (SF-36)

Scoring rate for quality of life (higher score-better quality of life) Minimum: 0 Maximum: 100

Time frame: up to 13 weeks

The scores of Celiac Disease-related Quality of Life (CDQOL)

Scoring rate for quality of life in celiac disease participants Minimum: 1 (total disagreement) Maximum: 5 (total agreement)

Time frame: up to 13 weeks

Adverse events

Incidence and severity of adverse events

Time frame: up to 13 weeks

Adverse events' relationship to gluten exposure

Incidence and severity of adverse events' relationship to gluten exposure

Time frame: up to 13 weeks

Safety as assessed by systolic and diastolic by blood pressure

Abnormality in blood pressure

Time frame: up to 13 weeks

Safety as assessed by body temperature

Abnormality in body temperature

Time frame: up to 13 weeks

Safety as assessed by pulse rate

Abnormality in pulse rate

Time frame: up to 13 weeks

Safety as assessed by respiratory rate

Abnormality in respiratory rate

Time frame: up to 13 weeks

Safety as assessed by percutaneous oxygen saturation

Abnormality in percutaneous oxygen saturation

Time frame: up to 13 weeks

Safety as assessed by hematology test with counting blood cells

Incidence of hematology abnormalities

Time frame: up to 13 weeks

Safety as assessed by blood chemistry test with measuring chemicals

Incidence of blood chemistry abnormalities

Time frame: up to 13 weeks

Safety as assessed by coagulation testing with thrombolytic capacity measurement

Incidence of coagulation abnormalities

Time frame: up to 13 weeks

Safety as assessed by urinalysis test with examining the visual, chemical and microscopic aspects

Incidence of urinalysis abnormalities

Time frame: up to 13 weeks

Safety as assessed by Electrocardiograms (QT interval)

Abnormality in QT interval

Time frame: up to 13 weeks

Safety as assessed by Electrocardiograms (heart rate)

Abnormality in heart rate

Time frame: up to 13 weeks

Celiac disease serology levels

Serology levels about tissue transglutaminase-2-IgA (tTG2-IgA; unit/mL)

Time frame: up to 13 weeks

Celiac disease serology levels

Serology levels about Deamidated gliadin peptide-IgA (DGP-IgA; unit), and deamidated gliadin peptide-IgG (DGP-IgG; unit)

Time frame: up to 13 weeks

3072 Blood biomarkers profile

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)

Time frame: up to 13 weeks

48 Blood biomarker profile

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)

Time frame: up to 13 weeks

Change from baseline in 3072 blood biomarkers profile (Cohort A only)

Change from baseline in 3072 blood biomarker profile measured by proteomics after gluten/sham gluten challenge (Cohort A only)

Time frame: up to 13 weeks

Change from baseline in 48 blood biomarkers profile (Cohort A only)

Change from baseline in 48 blood biomarkers profile measured by proteomics after gluten/sham gluten challenge (Cohort A only)

Time frame: up to 13 weeks

The incidence of novel digital biomarker (Cohort B only)

The incidence of novel digital biomarker established in Cohort A (Cohort B only)

Time frame: up to 13 weeks

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

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes