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

Celiac Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05686369
• Other study ID #: DQB002UZ
• Status: Completed
• Start date: March 8, 2023
• Est. completion date: October 5, 2023

Study information

• Verified date: November 2023
• Source: Chugai Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 5, 2023
• Est. primary completion date: October 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Celiac Disease

Locations

Country	Name	City	State
United States	Science 37	Culver City	California

Sponsors (1)

Lead Sponsor	Collaborator
Chugai Pharmaceutical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The concordance between the novel digital biomarker and the presence of celiac disease-related symptoms		up to 13 weeks
Secondary	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)	up to 13 weeks
Secondary	The comprehensive measurement	The comprehensive measurement objectively evaluated by wearable biosensor	up to 13 weeks
Secondary	The scores of Celiac Disease Symptom Diary (CDSD)	Scoring rate for celiac disease symptoms Minimum: Non Maximum: Very severe	up to 13 weeks
Secondary	The scores of Short Form 36 (SF-36)	Scoring rate for quality of life (higher score-better quality of life) Minimum: 0 Maximum: 100	up to 13 weeks
Secondary	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)	up to 13 weeks
Secondary	Adverse events	Incidence and severity of adverse events	up to 13 weeks
Secondary	Adverse events' relationship to gluten exposure	Incidence and severity of adverse events' relationship to gluten exposure	up to 13 weeks
Secondary	Safety as assessed by systolic and diastolic by blood pressure	Abnormality in blood pressure	up to 13 weeks
Secondary	Safety as assessed by body temperature	Abnormality in body temperature	up to 13 weeks
Secondary	Safety as assessed by pulse rate	Abnormality in pulse rate	up to 13 weeks
Secondary	Safety as assessed by respiratory rate	Abnormality in respiratory rate	up to 13 weeks
Secondary	Safety as assessed by percutaneous oxygen saturation	Abnormality in percutaneous oxygen saturation	up to 13 weeks
Secondary	Safety as assessed by hematology test with counting blood cells	Incidence of hematology abnormalities	up to 13 weeks
Secondary	Safety as assessed by blood chemistry test with measuring chemicals	Incidence of blood chemistry abnormalities	up to 13 weeks
Secondary	Safety as assessed by coagulation testing with thrombolytic capacity measurement	Incidence of coagulation abnormalities	up to 13 weeks
Secondary	Safety as assessed by urinalysis test with examining the visual, chemical and microscopic aspects	Incidence of urinalysis abnormalities	up to 13 weeks
Secondary	Safety as assessed by Electrocardiograms (QT interval)	Abnormality in QT interval	up to 13 weeks
Secondary	Safety as assessed by Electrocardiograms (heart rate)	Abnormality in heart rate	up to 13 weeks
Secondary	Celiac disease serology levels	Serology levels about tissue transglutaminase-2-IgA (tTG2-IgA; unit/mL)	up to 13 weeks
Secondary	Celiac disease serology levels	Serology levels about Deamidated gliadin peptide-IgA (DGP-IgA; unit), and deamidated gliadin peptide-IgG (DGP-IgG; unit)	up to 13 weeks
Secondary	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)	up to 13 weeks
Secondary	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)	up to 13 weeks
Secondary	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)	up to 13 weeks
Secondary	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)	up to 13 weeks
Secondary	The incidence of novel digital biomarker (Cohort B only)	The incidence of novel digital biomarker established in Cohort A (Cohort B only)	up to 13 weeks