What is the CeDar Rose study?

The CeDar Rose study is for people who have well-controlled celiac disease. This study is an observational study, meaning there is no investigational medicine being evaluated. Instead, participants will wear a medical device that monitors various biometrics. Additionally, participants will be periodically sent a random sample of either gluten or sham (fake) gluten to ingest.

This is a decentralized study, so all study activities are conducted remotely or at the participant’s home. Visits and e-consent is home-based, conducted via telemedicine during a videoconference session and facilitated by home nursing (HN) professionals at the participant’s home.

Who can join the CeDar Rose study?

Study participants may be able to join the study if they meet the following requirements:

• You are 18-65 years old
• You have celiac disease diagnosed by biopsy showing at least partial villous atrophy and positive celiac serology. You must be able to obtain a copy of the biopsy report from your gastroenterologist and provide it to your study doctor.
• You have been on a gluten-free diet at least 12 months prior to screening

Other study requirements will apply.

What will happen during the study?

Study participants can expect the following:

• Review & sign the Informed Consent Form
• Screening (6 weeks): Receive study health assessments to confirm if you qualify for the study.
• Observation Period (13 weeks): Participants will wear the wearable device, complete daily questionnaires, and randomly receive both gluten challenges and sham gluten challenges orally.

Participation in a clinical research study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.