Clinical trial NCT05686369: A Decentralized Home-Based Study To Investigate Novel Objective Biomarker Of Gluten-Mediated Symptoms In Celiac Disease Participants (CeDar ROSE Study)
Official title: A Decentralized Home-Based Study To Investigate Novel Objective Biomarker Of Gluten-Mediated Symptoms Using A Wearable Biosensor And A Mobile Platform In Celiac Disease Participants With And Without Gluten Challenge (CeDar ROSE Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Celiac Disease
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2023-01-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort A: Well-controlled celiac disease participants who should be asymptomatic or mildly symptomatic 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

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.


Eligibility 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

Primary outcomes:
measure: The concordance between the novel digital biomarker and the presence of celiac disease-related symptoms
timeFrame: up to 13 weeks
Secondary outcomes:
measure: Correlations between the comprehensive measurement and the scores of patient reported outcomes
timeFrame: up to 13 weeks
measure: The comprehensive measurement
timeFrame: up to 13 weeks
measure: The scores of Celiac Disease Symptom Diary (CDSD)
timeFrame: up to 13 weeks
measure: The scores of Short Form 36 (SF-36)
timeFrame: up to 13 weeks
measure: The scores of Celiac Disease-related Quality of Life (CDQOL)
timeFrame: up to 13 weeks
measure: Adverse events
timeFrame: up to 13 weeks
measure: Adverse events' relationship to gluten exposure
timeFrame: up to 13 weeks
measure: Safety as assessed by systolic and diastolic by blood pressure
timeFrame: up to 13 weeks
measure: Safety as assessed by body temperature
timeFrame: up to 13 weeks
measure: Safety as assessed by pulse rate
timeFrame: up to 13 weeks
measure: Safety as assessed by respiratory rate
timeFrame: up to 13 weeks
measure: Safety as assessed by percutaneous oxygen saturation
timeFrame: up to 13 weeks
measure: Safety as assessed by hematology test with counting blood cells
timeFrame: up to 13 weeks
measure: Safety as assessed by blood chemistry test with measuring chemicals
timeFrame: up to 13 weeks
measure: Safety as assessed by coagulation testing with thrombolytic capacity measurement
timeFrame: up to 13 weeks
measure: Safety as assessed by urinalysis test with examining the visual, chemical and microscopic aspects
timeFrame: up to 13 weeks
measure: Safety as assessed by Electrocardiograms (QT interval)
timeFrame: up to 13 weeks
measure: Safety as assessed by Electrocardiograms (heart rate)
timeFrame: up to 13 weeks
measure: Celiac disease serology levels
timeFrame: up to 13 weeks
measure: Celiac disease serology levels
timeFrame: up to 13 weeks
measure: 3072 Blood biomarkers profile
timeFrame: up to 13 weeks
measure: 48 Blood biomarker profile
timeFrame: up to 13 weeks
measure: Change from baseline in 3072 blood biomarkers profile (Cohort A only)
timeFrame: up to 13 weeks
measure: Change from baseline in 48 blood biomarkers profile (Cohort A only)
timeFrame: up to 13 weeks
measure: The incidence of novel digital biomarker (Cohort B only)
timeFrame: up to 13 weeks
Other outcomes:
Locations:
city: Culver City
country: United States
facility: Science 37
state: California
Study officials:
affiliation: clinical-trials@chugai-pharm.co.jp
name: Sponsor Chugai Pharmaceutical Co. Ltd
role: STUDY_DIRECTOR
References: