Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06519916
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-05-28
Brief Title:
Mental Perfomance in Patients With Coeliac Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Does a Gluten-free Diet Change the Mental Performance A Comparative Study of Cognitive Function Among Children With Coeliac Disease and Healthy Controls
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Between July 2020 and August 2021 all children aged between 6 and 18 years under the care of the University Childrens hospital of Basel and the Childrens hospital of Aarau Switzerland diagnosed with CD according to the Guidelines for diagnosing CD of the European Society for Paediatric Gastroenterology Hepatology and Nutrition were informed about the study Further inclusion criteria were a strict adherence to the diet defined as a negative transglutaminase for at least one year before participation in the study Exclusion criteria comprised a diagnosis made less than a year ago the presence of other chronic diseases including food allergies and the intake of regular medication CD patients and their parents were informed about the study during the regular appointment for a clinical and serological check-up After obtaining their consent patients received another appointment to participate in the study
For every CD-patient an age-and-sex-matched healthy control was recruited Exclusion criteria for healthy controls were chronic diseases regular medication intake food allergies or specific diets
Firstly all participants were asked to fill in the questionnaire to examine the QOL Kidscreen52 was used a standardized questionnaire containing 52 questions developed to assess the subjective health and the psychological mental and social well-being of children and adolescents covering ten important aspects of life physical well-being psychological well-being moods emotions self-perception autonomy parent relation home life financial resources peers social support school environment bullying The answers to all questions were converted into numbers from one to five In most subgroups a higher number indicates a more positive answer except for self-perception questions are like do you doubt your appearance etc and bullying where a lower number indicates also less exposure to bullying Participants were also asked to fill in the ISI insomnia severety index a 7-item self-report standardized questionnaire assessing the nature severity and impact of insomnia
Participants completed a computerized Flanker task to assess cognitive performance In this cognitive task the target was flanked by non-target stimuli which correspond either to the same directional response as the target congruent flankers or to the opposite response incongruent flankers In our child-friendly variant participants were presented with five fish in a row and were asked to press the correct button according to the orientation of the target central fish Participants were instructed to respond as accurately and as quickly as possible The two different conditions were presented with equal probability Visual stimuli were shown for 200 ms against a black background followed by a blank inter-trial period of random length between 900 and 1300 ms Participants completed one practice block and two test blocks with 40 trials each Flanker task is a reliable well-recognized neuropsychological test for assessing executive function Mean reaction times on response-correct trials and accuracy rates were calculated for congruent and incongruent trials
To have consistency the interviews and instructions for Flanker task were conducted by the same three students Uncomplete patient data sets were excluded
For every CD-patient an age-and-sex-matched healthy control was recruited Exclusion criteria for healthy controls were chronic diseases regular medication intake food allergies or specific diets
Firstly all participants were asked to fill in the questionnaire to examine the QOL Kidscreen52 was used a standardized questionnaire containing 52 questions developed to assess the subjective health and the psychological mental and social well-being of children and adolescents covering ten important aspects of life physical well-being psychological well-being moods emotions self-perception autonomy parent relation home life financial resources peers social support school environment bullying The answers to all questions were converted into numbers from one to five In most subgroups a higher number indicates a more positive answer except for self-perception questions are like do you doubt your appearance etc and bullying where a lower number indicates also less exposure to bullying Participants were also asked to fill in the ISI insomnia severety index a 7-item self-report standardized questionnaire assessing the nature severity and impact of insomnia
Participants completed a computerized Flanker task to assess cognitive performance In this cognitive task the target was flanked by non-target stimuli which correspond either to the same directional response as the target congruent flankers or to the opposite response incongruent flankers In our child-friendly variant participants were presented with five fish in a row and were asked to press the correct button according to the orientation of the target central fish Participants were instructed to respond as accurately and as quickly as possible The two different conditions were presented with equal probability Visual stimuli were shown for 200 ms against a black background followed by a blank inter-trial period of random length between 900 and 1300 ms Participants completed one practice block and two test blocks with 40 trials each Flanker task is a reliable well-recognized neuropsychological test for assessing executive function Mean reaction times on response-correct trials and accuracy rates were calculated for congruent and incongruent trials
To have consistency the interviews and instructions for Flanker task were conducted by the same three students Uncomplete patient data sets were excluded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None