Mental Perfomance in Patients With Coeliac Disease

NCT06519916 | Completed

• 1 other identifier: 2019-01095
• Study Type: observational
• Target: 444
• Locations: 1 country
• Sites: 1

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.

Conditions

Celiac Disease in Children; Gluten Allergy

Keywords

mental performance; gluten-free diet; microbiome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quality of life (qol)

  cross-sectional

Study Arms (2)

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

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

Interventions

Assessment of mental performance BEHAVIORAL

There was no intervention, the mental performance was assessed

Healthy control group; Patients with CD

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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)

Sponsors & Collaborators

• University Children's Hospital Basel: lead

Study Sites (1)

University Children's HOspital

Basel, Switzerland

Location

Study Officials

• Corinne Legeret

  University Children's Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: July 25, 2024
• Study Start: July 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)