Mental Perfomance in Patients With Coeliac Disease (NCT06519916) | Clinical Trial Compass
CompletedNot Applicable
Mental Perfomance in Patients With Coeliac Disease
Switzerland444 participantsStarted 2020-07-01
Plain-language summary
Coeliac disease (CD) is an immune-mediated systemic disorder triggered by gluten in genetically predisposed patients. The only available treatment is a strict life long gluten-free diet (GFD), which has been linked to a reduced quality of life (QOL) and causes alterations in the gastrointestinal microbiome. Abnormal compositions of the microbiome are now recognized as factors in the pathogenesis of neuropsychological disorders via gut-brain-axis. The aim of this study was to assess the QOL and the mental performance of children and teenagers with CD and compare it to healthy controls (HC).
Methods: Children between the ages of 6 and 18 years with CD and age-and-sex-matched healthy controls (HC) filled in a questionnaire to assess QOL and performed the Flanker task, a standardized test to assess cognitive performance.
Who can participate
Age range
4 Years – 18 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:
* CD diagnosed according to European guidelines (ESPGHAN)
* only patients, who stick to a strict glutenfree diet (measured by transglutaminase for at least a year before participation in the study)
Exclusion Criteria: - any other chronic disease
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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.
1This trial studied mental performance in children with celiac disease — has my child's gluten-free diet been in place long enough that it might have already improved their cognitive function, or is there still a reason to look more closely at how their thinking and learning are affected?
2Since this trial is now completed, would it be worth asking the researchers or my doctor whether any results have been published, and what those findings might mean for how we monitor my child's mental performance going forward?
3The study looked at mental performance specifically in children with celiac disease — are there particular areas of thinking, memory, or concentration that my doctor recommends we watch for in my child, given what research like this has shown about the condition?
4If my child is still having cognitive or learning difficulties despite following a strict gluten-free diet, does my doctor think a formal assessment of their mental performance — like the kind used in this study — would be useful for us to pursue?
5Is there anything about how this study was designed or what it was measuring that my doctor thinks is directly relevant to decisions we should be making right now about my child's care or schooling support?
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.