Virtual Celiac Symptoms Study in Adults and Teenagers
Assessment of Symptom Patterns in Celiac Disease: A Prospective Longitudinal Survey
1 other identifier
observational
480
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2022
CompletedFirst Posted
Study publicly available on registry
April 4, 2022
CompletedStudy Start
First participant enrolled
August 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 4, 2023
CompletedMarch 10, 2023
March 1, 2023
7 months
March 25, 2022
March 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Each Gastrointestinal Symptom and Tiredness Assessed by the Celiac Disease Symptom Diary (CDSD)
The CDSD is a celiac specific symptom assessment tool administered daily. The symptoms measured will include diarrhea, abdominal pain, bloating, nausea/vomiting, number of bowel movements and tiredness. Presence and count of each symptom will be reported for the overall sample as well as separately for adults (age greater than or equal to \[\>=\] 18) and adolescents (age \>=12 less than \[\<\] 18).
Up to 12 weeks
Number of Participants With Presence of Non-gastrointestinal (GI) Symptoms
Non-GI symptoms include: Headache, Brain fog (feeling confused or disorganized, or finding it hard to put thoughts into words), Dermatitis herpetiformis (DH) or other rash (suspected to be related to gluten exposure), Joint/body pain (suspected to be related to gluten exposure), Irritability (feeling easily upset or frustrated), Mouth sores/canker sores, and others. Presence/count of each symptom will be assessed overall and separately for adults (age \>=18) and adolescents (age \>=12 and \<18).
Up to 12 weeks
Secondary Outcomes (4)
Number of Participants With Presence/Absence of Known and Suspected Gluten Exposure
Up to 12 weeks
Quality of Life (QoL) as Measured by the 12-Item Short Form Survey (SF-12) Version 2 (v2)
Up to 12 weeks
Number of Participants With Healthcare Resource Utilization (HCRU)
Up to 12 weeks
Work Productivity Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire
Up to 12 weeks
Study Arms (1)
Participants with CeD
Participants diagnosed with CeD will be observed prospectively for CeD symptom patterns over a 3-month period.
Interventions
Eligibility Criteria
Participants diagnosed with CeD in the United States.
You may qualify if:
- 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).
You may not qualify if:
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (1)
Takeda
Lexington, Massachusetts, 02421, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2022
First Posted
April 4, 2022
Study Start
August 16, 2022
Primary Completion
March 4, 2023
Study Completion
March 4, 2023
Last Updated
March 10, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.