Different Dietary Practices in Children with Autism Spectrum Disorder

NCT ID: NCT06852027

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2026-07-31

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.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Gluten-Free-Casein-Free Diet

The Gluten-free Casein-free diet is one of the most researched diets for Autism Spectrum Disorder. This diet is based on the elimination of foods containing gluten and casein. In this arm, children between the ages of 3 and 10 will be subjected to a Gluten-free-Casein-free diet for 12 weeks. Children will be controlled for compliance with the diet every two weeks.

Group Type: EXPERIMENTAL

Different Dietary Practices

Intervention Type: OTHER

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

Feingold Diet

The Feingold Diet was originally developed for Attention Deficit and Hyperactivity Disorder, it is thought to be effective in symptomatic treatment due to enzyme deficiency in children with Autism Spectrum Disorder, but there are not enough studies on it. The Feingold Diet is one of the most researched diets for Autism Spectrum Disorder. This diet is based on the elimination of foods containing gluten and casein. In this arm, children between the ages of 3 and 10 will be subjected to a the Feingold Diet diet for 12 weeks. Children will be controlled for compliance with the diet every two weeks.

Group Type: EXPERIMENTAL

Different Dietary Practices

Intervention Type: OTHER

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

Control

the arm receives no intervention during the study. (CONTROL GROUP). Children in this group will be monitored every 2 weeks for 12 weeks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aydin Adnan Menderes University

OTHER

Sponsor Role: lead

Responsible Party

Simge Gürel

Master student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aydin province Efeler Autism Life Center

Aydin, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E-15189967-050.04-593675

Identifier Type: -

Identifier Source: org_study_id