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Celiac DiseaseNCT05686369

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

An observational study of Celiac Disease, run by Chugai Pharmaceutical at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Celiac Disease
How many people
12 participants
Where
1 siteUnited States
Study dates
8 Mar 2023to 5 Oct 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • [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
Show all 9Show fewer
  • 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)

Who cannot join

  • [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 locations and contacts

1 site in 1 country.

United States1 site

  • Science 37

    Culver City, California, 90230

Other trials in United States

About this 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)

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.

Read more

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.

Conditions
Celiac Disease
Medical subject headings
Celiac Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05686369
Study groupRoleWhat they receive
Cohort A: Well-controlled Celiac DiseaseCohort A: Well-controlled celiac disease participants who should be asymptomatic or mildly symptomatic
Cohort B: Non-Responsive Celiac DiseaseCohort 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: up to 13 weeks

Secondary outcomes (25)

  1. 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)

    Measured: up to 13 weeks

  2. The comprehensive measurement

    The comprehensive measurement objectively evaluated by wearable biosensor

    Measured: up to 13 weeks

  3. The scores of Celiac Disease Symptom Diary (CDSD)

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

    Measured: up to 13 weeks

  4. The scores of Short Form 36 (SF-36)

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

    Measured: up to 13 weeks

  5. 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)

    Measured: up to 13 weeks

  6. Adverse events

    Incidence and severity of adverse events

    Measured: up to 13 weeks

  7. Adverse events' relationship to gluten exposure

    Incidence and severity of adverse events' relationship to gluten exposure

    Measured: up to 13 weeks

  8. Safety as assessed by systolic and diastolic by blood pressure

    Abnormality in blood pressure

    Measured: up to 13 weeks

  9. Safety as assessed by body temperature

    Abnormality in body temperature

    Measured: up to 13 weeks

  10. Safety as assessed by pulse rate

    Abnormality in pulse rate

    Measured: up to 13 weeks

  11. Safety as assessed by respiratory rate

    Abnormality in respiratory rate

    Measured: up to 13 weeks

  12. Safety as assessed by percutaneous oxygen saturation

    Abnormality in percutaneous oxygen saturation

    Measured: up to 13 weeks

  13. Safety as assessed by hematology test with counting blood cells

    Incidence of hematology abnormalities

    Measured: up to 13 weeks

  14. Safety as assessed by blood chemistry test with measuring chemicals

    Incidence of blood chemistry abnormalities

    Measured: up to 13 weeks

  15. Safety as assessed by coagulation testing with thrombolytic capacity measurement

    Incidence of coagulation abnormalities

    Measured: up to 13 weeks

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

    Incidence of urinalysis abnormalities

    Measured: up to 13 weeks

  17. Safety as assessed by Electrocardiograms (QT interval)

    Abnormality in QT interval

    Measured: up to 13 weeks

  18. Safety as assessed by Electrocardiograms (heart rate)

    Abnormality in heart rate

    Measured: up to 13 weeks

  19. Celiac disease serology levels

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

    Measured: up to 13 weeks

  20. Celiac disease serology levels

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

    Measured: up to 13 weeks

  21. 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)

    Measured: up to 13 weeks

  22. 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)

    Measured: up to 13 weeks

  23. 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)

    Measured: up to 13 weeks

  24. 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)

    Measured: up to 13 weeks

  25. The incidence of novel digital biomarker (Cohort B only)

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

    Measured: up to 13 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2023
  2. Study start8 Mar 2023
  3. Primary completion5 Oct 2023
  4. Study completion5 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05686369
Sponsor's protocol ID
DQB002UZ
Status last verified
Nov 2023
First submitted
8 Nov 2022
Last updated
3 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds\_request.html).

Questions about this trial

What is this clinical trial studying?

An observational study of Celiac Disease, run by Chugai Pharmaceutical at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The concordance between the novel digital biomarker and the presence of celiac disease-related symptoms (time frame: up to 13 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05686369.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.

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