Virtual Celiac Symptoms Study in Adults and Teenagers

Takeda

Status: Completed

Conditions: Celiac Disease

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT05309330

TAK-101-5001

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 480 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. At least 12 years of age or older.
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

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.

Trial design

480 participants in 1 patient group

Participants with CeD

Description:

Participants diagnosed with CeD will be observed prospectively for CeD symptom patterns over a 3-month period.

Treatment:

Other: No Intervention