CompletedNot Applicable

Virtual Celiac Symptoms Study in Adults and Teenagers

United States480 participantsStarted 2022-08-16

Plain-language 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 CeD for 12 weeks. There are no blood draws, gluten challenges, medications, or doctor visits required.

Who can participate

Age range12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

What they're measuring

Number of Participants With Each Gastrointestinal Symptom and Tiredness Assessed by the Celiac Disease Symptom Diary (CDSD)

Timeframe: Up to 12 weeks

Number of Participants With Presence of Non-gastrointestinal (GI) Symptoms

Timeframe: Up to 12 weeks

Trial details

NCT IDNCT05309330

SponsorTakeda

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-03-04

View on ClinicalTrials.gov More Celiac Disease trials