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NCT05686369 · ClinicalTrials.gov registry record
A Decentralized Home-Based Study To Investigate Novel Objective Biomarker Of Gluten-Mediated Symptoms In Celiac Disease Participants (CeDar ROSE Study)
A clinical trial of Celiac Disease, sponsored by Chugai Pharmaceutical.
- Completed
- Registry status
- 12
- Enrollment target
- 1
- Study location
NCT05686369 is a study of Celiac Disease that has completed, run by Chugai Pharmaceutical. The registered enrollment target is 12 participants, below the 1,980-participant average among 24 other Celiac Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05686369, a study of Celiac Disease, has completed, sponsored by Chugai Pharmaceutical.
- COMPLETED
- Registry status
- 12 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Study Locations (1)
California
- Science 37 - Culver City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2023-03-08 |
| Est. Completion | 2023-10-05 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05686369
The ClinicalTrials.gov registry entry for NCT05686369 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,980-participant average among 24 other Celiac Disease trials with a reported enrollment target (99% lower). The listed sponsor is Chugai Pharmaceutical, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Celiac Disease appearing as the primary indexed condition, and to 0 interventions.
NCT05686369 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05686369 about?
NCT05686369 is a clinical study titled "A Decentralized Home-Based Study To Investigate Novel Objective Biomarker Of Gluten-Mediated Symptoms In Celiac Disease Participants (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 a...
What is the current status of trial NCT05686369?
This trial is currently completed. The enrollment target is 12 participants. The study started on 2023-03-08. Estimated completion is 2023-10-05.
What conditions does trial NCT05686369 study?
This clinical trial studies the following conditions: Celiac Disease.
Who is sponsoring clinical trial NCT05686369?
This trial is sponsored by Chugai Pharmaceutical, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05686369 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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