Status:
COMPLETED
Virtual Celiac Symptoms Study in Adults and Teenagers
Lead Sponsor:
Takeda
Conditions:
Celiac Disease
Eligibility:
All Genders
12+ years
Brief Summary
The goal of this study is to better understand the symptoms and impacts of celiac disease (CeD). Participants use a smart phone online app to answer daily questionnaires about symptoms and life with C...
Detailed Description
This is an observational, prospective study to measure symptoms and impacts of CeD. This study will assess CeD symptom patterns over a 3-month observation period. The study will enroll approximately ...
Eligibility Criteria
Inclusion
- At least 12 years of age or older.
- Diagnosed with CeD for at least 1 year.
- For participants diagnosed over the age of 18: Biopsy confirmed diagnosis with CeD (participant reported).
- For participants diagnosed under the age of 18: Blood test or biopsy confirmed diagnosis with CeD (participant reported).
- Currently following a gluten free diet (GFD) for at least 6 months.
- Has experienced symptoms believed by the participant to be CeD related in the last 3 months.
- Has daily access to a smartphone as well as internet/Wi-Fi/cellular data.
- Speaks and reads English.
- Lives in the US (participant reported).
Exclusion
- 1\. Currently involved or planning to be involved in any clinical studies with an investigational drug, surgical procedure, or gluten challenge over the 3-month observation period.
Key Trial Info
Start Date :
August 16 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 4 2023
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT05309330
Start Date
August 16 2022
End Date
March 4 2023
Last Update
March 10 2023
Active Locations (1)
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1
Takeda
Lexington, Massachusetts, United States, 02421