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COMPLETED

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

NCT05686369 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 12 participants
Start Date 2023-03-08
Est. Completion 2023-10-05

Sponsor

Chugai Pharmaceutical

35 total trials

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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. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Chugai Pharmaceutical, which has 35 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Celiac Disease appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05686369 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

Who is sponsoring clinical trial NCT05686369?

This trial is sponsored by Chugai Pharmaceutical, which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial