Mental Perfomance in Patients With Coeliac Disease

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

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.

Study Overview

• Status: Completed
• Conditions: Celiac Disease in Children; Gluten Allergy
• Intervention / Treatment: Behavioral: Assessment of mental performance

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 444

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland
    • University Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children diagnosed with CD according to the Guidelines for diagnosing CD of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN), 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

Description

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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Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with CD; Patients with CD, who have been diagnosed according to the Guidelines for diagnosing CD of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition and stick strictly to a gluten-free diet (transglutaminase negative, at least for a year)	Behavioral: Assessment of mental performance; There was no intervention, the mental performance was assessed
Healthy control group; Age-and-sex-matched healthy control. Exclusion criteria for healthy controls were chronic diseases, regular medication intake, food allergies or specific diets.	Behavioral: Assessment of mental performance; There was no intervention, the mental performance was assessed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental performance	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.	cross-sectional

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life (qol)	The outcome of qol was compared. To assess the quality of life, all participants had to fill in the questionnaire (Kidscreen-52) at the same time, than the Flanker-Test. All tests were performed within one year. Both tests were compared between the patients with Coeliac disease and the healthy control group. In other words, it is a snapshot, as the Flanker test and the quality of life survey were carried out on the same day. For the qol, the higher the score, the higher the qol	cross-sectional

Collaborators and Investigators

• Sponsor: University Children's Hospital Basel
• Investigators: Principal Investigator: Corinne Legeret, University Children's Hospital Basel

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: May 28, 2024
• First Submitted That Met QC Criteria: July 19, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 19, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: microbiome; gluten-free diet; mental performance
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Celiac Disease
• Other Study ID Numbers: 2019-01095

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No