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临床试验/NCT06519916
NCT06519916已完成不适用

Does a Gluten-free Diet Change the Mental Performance? A Comparative Study of Cognitive Function Among Children With Coeliac Disease and Healthy Controls

University Children's Hospital Basel1 个研究点 分布在 1 个国家目标入组 444 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
444
试验地点
1
主要终点
Mental performance

研究概览

简要总结

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.

详细描述

Between July 2020 and August 2021, all children aged between 6 and 18 years, under the care of the University Children's hospital of Basel and the Children's 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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
4 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • any other chronic disease

结局指标

主要结局

Mental performance

时间窗: cross-sectional

The performance of the Flanker -Test was compared. Flanker-Test is a standardised test to assess mental performance. All participants performed this Flanker-Test (Computer Test) and afterwards the quality of life (see below ) was assessed. There was no follow-up, in this study participants with Coeliac disease and healthy controls only performed the Flanker-Test and the assessment of Quality of life (qol)and both groups were compared to each other. In other words, it is a snapshot, as the Flanker test and the quality of life survey were carried out on the same day.

次要结局

  • Quality of life (qol)(cross-sectional)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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