Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
480 participants
OBSERVATIONAL
2022-08-16
2023-03-04
Brief Summary
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Detailed Description
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This study will assess CeD symptom patterns over a 3-month observation period. The study will enroll approximately 400 participants.
The data will be prospectively collected, via a self-reported ePRO platform accessible by smartphone.
This virtual study will be conducted in the United States.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants with CeD
Participants diagnosed with CeD will be observed prospectively for CeD symptom patterns over a 3-month period.
No Intervention
This is a non-interventional study.
Interventions
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No Intervention
This is a non-interventional study.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with CeD for at least 1 year.
3. For participants diagnosed over the age of 18: Biopsy confirmed diagnosis with CeD (participant reported).
4. For participants diagnosed under the age of 18: Blood test or biopsy confirmed diagnosis with CeD (participant reported).
5. Currently following a gluten free diet (GFD) for at least 6 months.
6. Has experienced symptoms believed by the participant to be CeD related in the last 3 months.
7. Has daily access to a smartphone as well as internet/Wi-Fi/cellular data.
8. Speaks and reads English.
9. Lives in the US (participant reported).
Exclusion Criteria
12 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Takeda
Lexington, Massachusetts, United States
Countries
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Related Links
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To obtain more information on the study, click here/on this link
Other Identifiers
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TAK-101-5001
Identifier Type: -
Identifier Source: org_study_id
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