Clinical trial NCT05309330: Virtual Celiac Symptoms Study in Adults and Teenagers
Official title: Assessment of Symptom Patterns in Celiac Disease: A Prospective Longitudinal Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Celiac Disease
Keywords: Celiac Disease
Signs and Symptoms
Digestive
Quality of Life
Diet
Gluten-Free
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2022-04-04
Enrollment: 480
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants diagnosed with CeD in the United States.

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

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Each Gastrointestinal Symptom and Tiredness Assessed by the Celiac Disease Symptom Diary (CDSD)
timeFrame: Up to 12 weeks
measure: Number of Participants With Presence of Non-gastrointestinal (GI) Symptoms
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Number of Participants With Presence/Absence of Known and Suspected Gluten Exposure
timeFrame: Up to 12 weeks
measure: Quality of Life (QoL) as Measured by the 12-Item Short Form Survey (SF-12) Version 2 (v2)
timeFrame: Up to 12 weeks
measure: Number of Participants With Healthcare Resource Utilization (HCRU)
timeFrame: Up to 12 weeks
measure: Work Productivity Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Takeda
state: Massachusetts
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: