Virtual Celiac Symptoms Study in Adults and Teenagers (NCT05309330) | Clinical Trial Compass
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 range
12 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Each Gastrointestinal Symptom and Tiredness Assessed by the Celiac Disease Symptom Diary (CDSD)
Timeframe: Up to 12 weeks
2
Number of Participants With Presence of Non-gastrointestinal (GI) Symptoms