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Enrolling by invitation NCT06852027

Different Dietary Practices in Children with Autism Spectrum Disorder

No phase Interventional Autism Spectrum Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Different Dietary Practices.
Who it may be relevant to
Registry conditions: Autism Spectrum Disorder. Basic parameters: 3 years — 10 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of the Effects of Different Dietary Practices on Quality of Life and Eating Behavior in Children with Autism Spectrum Disorder

Overview

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.

Interventions

  • Other Different Dietary Practices
    The aim was to investigate the effects of Gluten-Casein-Free Diet and Feingold Diet on gastrointestinal complaints in children with Autism Spectrum Disorder.

Primary outcome measures

  • Gastrointestinal symptoms [Time frame: Baseline and 3 months]
  • Eating behaviors [Time frame: Baseline and 3 months]
  • Pediatric Quality of Life [Time frame: Baseline and 3 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Aydin province Efeler Autism Life Center — Aydin

Identifiers

NCT: NCT06852027 · E-15189967-050.04-593675

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗