Clinical trial NCT06852027: Different Dietary Practices in Children with Autism Spectrum Disorder
Official title: Evaluation of the Effects of Different Dietary Practices on Quality of Life and Eating Behavior in Children with Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Quality of Life
Eating Behavior
Autism Spectrum Disorder
gluten-free-casein-free diet
feingold diet
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 45
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to investigate the effects of gluten-free casein-free diet and feingold diet on gastrointestinal system (GI) symptoms , eating behavior and quality of life in children with autism spectrum disorder. Research questions are below:

Is there a difference in the effects of a gluten-free-casein-free diet and the Feingold Diet on GI symptoms? Is there a difference in the effects of a gluten-free-casein-free diet and the Feingold Diet on eating behavior? Is there a difference in the effects of a gluten-free-casein-free diet and the Feingold Diet on quality of life?

Detailed description: Autism Spectrum Disorder is defined as different neurodevelopmental disorders characterized by social communication, restrictive, repetitive, and typical behaviors and interests. Although it is not known precisely how the disease develops, literature reviews see genetic and environmental factors as the leading causes. The prevalence of Autism Spectrum Disorder is increasing day by day. There is no treatment for Autism Spectrum Disorder in light of the latest data. The applications made are primarily aimed at reducing stereotypical behaviors. Children with Autism Spectrum Disorder often experience gastrointestinal complaints such as diarrhea, constipation, abdominal pain, bloating, and gas. In addition, children with ASD also experience food selectivity, restrictive/avoidant feeding disorder, food neophobia, and nutritional problems due to sensory sensitivity. Considering these conditions, it is thought that dietary therapy may also be effective in the symptomatic treatment of Autism Spectrum Disorder with the support of studies conducted in recent years.

The Gluten-free Casein-free diet developed for Autism Spectrum Disorder is among the most researched diets. This diet is based on the elimination of foods containing gluten and casein. Although the other diet discussed in this study, the Feingold Diet, was developed initially for Attention Deficit and Hyperactivity Disorder, it is thought that it may be effective in symptomatic treatment due to enzyme deficiency in children with ASD. However, there are not enough studies on it. This study aimed to examine the effects of the Gluten-Casein-Free Diet and the Feingold Diet on gastrointestinal complaints in children with Autism Spectrum Disorder using the Scale of Eating Time Behaviors in Children with Autism (BAMBI), the Gastrointestinal Sensitivity Index and the Quality of Life Scale for Children. The study was planned to be conducted with 45 children with ASD between the ages of 3-10 registered at the Efeler Autism Life Center affiliated with the Efeler District Municipality of Aydın Province. Therefore, the necessary permissions will be obtained from the Efeler Autism Life Center, and the study will be submitted to the ethics committee for approval. The research data will be analyzed using the SPSS 22 (Statistical Package for the Social Sciences) program. Numbers and percentage distributions for descriptive feature data; correlation analyses will be used to determine the relationship and analyses appropriate for nonparametric and parametric data between the data.

Eligibility criteria: Inclusion Criteria:Children with autism between the ages of 3-10 registered at Efeler Autism Life Center in Aydın province.

The criteria for inclusion for the gluten-free-casein-free diet are as follows:

* Not having diseases such as celiac, lactose intolerance
* Not having previously applied a gluten-free diet, gluten-free casein-free diet, lactose-free diet
* Having gastrointestinal complaints

The criteria for inclusion for the Feingold Diet are as follows:

* Not having been diagnosed with attention deficit and hyperactivity disorder
* Not having previously taken the Feingold diet
* Not having any food allergies

Exclusion Criteria:People who do not comply with the diet or do not respond to the survey will be excluded from the study and the information obtained will not be used for the research.

* The patient is breastfed
* The patient has any chronic disease
* The patient has any psychiatric disease

Primary outcomes:
measure: Gastrointestinal symptoms
timeFrame: Baseline and 3 months
measure: Eating behaviors
timeFrame: Baseline and 3 months
measure: Pediatric Quality of Life
timeFrame: Baseline and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Aydin province Efeler Autism Life Center
Study officials:
References: