Different Dietary Practices in Children with Autism Spectrum Disorder

NCT06852027 | Enrolling By Invitation

• 1 other identifier: E-15189967-050.04-593675
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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?

Conditions

Autism Spectrum Disorder

Keywords

Quality of Life; Eating Behavior; Autism Spectrum Disorder; gluten-free-casein-free diet; feingold diet

Outcome Measures

Primary Outcomes (3)

• Gastrointestinal symptoms

  It will be evaluated whether there is a difference in the effects of the gluten-free-casein-free diet and the Feingold Diet on the gastrointestinal system. The evaluation will be made using the Gastrointestinal Sensitivity Index. Gastrointestinal Sensitivity Index: The GI sensitivity index assesses 0-17 points. A score of seven and above is a severe symptom in the child. The Gastrointestinal Sensitivity Index is applied by hospital personnel. It was prepared to examine children's digestive problems and their changes according to periods. The test consists of nine headings under the heading of symptoms: "Constipation, Diarrhea, Average Stool Density, Abdominal Hardness, Stool Odor, Flatulence, Abdominal Pain, Unexplained Daytime Irritability, Nighttime Awakening, and Abdominal Hardness." Each heading was matched with the answers numbered "0, 1, 2" and the sensitivity index was obtained.

  Baseline and 3 months

• Eating behaviors

  It will examine whether there is a difference between the effects of the gluten-free-casein-free diet and the Feingold Diet on eating behavior. Brief Autism Mealtime Behaviors Inventory (BAMBI): It was adapted into Turkish by Meral and Fidan in 2014. The scale consists of 18 items. It consists of three subscales: limited food variety, refusal, and autism-related behavioral characteristics. Items 3, 9, 10, and 15 are reverse-scored. Each item is scored as 1 for never, 2 for rarely/rarely, 3 for occasionally/sometimes, 4 for often, and 5 for always, according to its frequency of occurrence. The BAMBI-total score and subscale scores are as follows: For the limited food variety score, the total score of items 10, 11, 13, 14, 15, 16, 17, and 18 is evaluated; for the food refusal score, the total score of items 1, 2, 4, 7 and 8 is evaluated; and for the autism-specific behavior score, the total score of items 3, 5, 6, 9 and 12 is evaluated. High scores from the total and subscales indicate

  Baseline and 3 months

• Pediatric Quality of Life

  It will examine whether there is a difference between the effects of the gluten-free-casein-free diet and the Feingold Diet on quality of life. The Pediatric Quality of Life Inventory (PedsQL): The Children's Quality of Life Questionnaire (PedsQL) was developed by Varni and colleagues in 1999 to assess the health-related quality of life of children and adolescents between the ages of 2 and 18. The scale has four separate forms organized according to age group characteristics for the 2-4, 5-7, 8-12, and 13-18 age groups. The Turkish validity and reliability studies of the forms for the 5-7 age group were conducted by Üneri et al., and the Turkish validity and reliability studies of the forms for the 8-12 and 13-18 age groups were conducted by Memik et al. The scale, which has a parent-only form for the 2-4 age group, has both parent and child forms for other age groups. The scale has four subscales that question physical, emotional, social, and school-related functionality. While a fi

  Baseline and 3 months

Study Arms (3)

Gluten-Free-Casein-Free Diet

EXPERIMENTAL

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.

Other: Different Dietary Practices

Feingold Diet

EXPERIMENTAL

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.

Other: Different Dietary Practices

Control

NO INTERVENTION

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

Interventions

Different Dietary Practices 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; Gluten-Free-Casein-Free Diet

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Aydin province Efeler Autism Life Center

Aydin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Feeding Behavior

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavior, Animal; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master student

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 28, 2025
• Study Start: February 1, 2025
• Primary Completion: August 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)