Completed

Gluten-Free Casein-Free Diet for Children with Autism Spectrum Disorder

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This study aims to observe how a gluten-free and casein-free diet affects specific blood markers in children with autism spectrum disorder.

What is being tested

Gluten Free Casein Free Diet

+ Normal Diet

Other
Who is being recruted

Autism Spectrum Disorder+1

+ Mental Disorders

+ Child Development Disorders, Pervasive

From 3 to 6 Years
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: August 2024
See protocol details

Summary

Principal SponsorKaradeniz Technical University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2024

Actual date on which the first participant was enrolled.

This study focuses on understanding how a gluten-free and casein-free (GFCF) diet might affect children aged 3 to 6 who have been diagnosed with autism spectrum disorder (ASD). Researchers are interested in whether this diet can influence levels of certain proteins in the blood, namely zonulin and claudin-5, which are related to gut and brain barriers. The study also examines changes in brain activity using EEG, and looks at how the diet might impact autism symptoms and other clinical signs. This research is important because it could offer new insights into dietary interventions that might help improve the wellbeing of children with ASD. Participants in the study will follow a GFCF diet for 12 weeks. Throughout the study, children will undergo various evaluations, including blood tests to measure levels of zonulin and claudin-5, assessments of autism symptoms using standardized scales, and EEG tests to observe any changes in brain activity. The study ensures that children continue to receive their regular special education hours. The potential benefits of the study include improving understanding of how diet affects the gut and brain in children with ASD, which could lead to better management of the condition. However, children not adhering to the diet or missing special education sessions will be excluded from the study to maintain consistent data.

Official TitleEffect of Gluten-free Casein-free Diet on Serum Zonulin and Claudin-5 Levels and Some Clinical Symptoms in Children With Autism Spectrum Disorder: A Randomized Controlled Trial
Principal SponsorKaradeniz Technical University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

21 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 3 to 6 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autism Spectrum DisorderMental DisordersChild Development Disorders, PervasiveNeurodevelopmental Disorders

Criteria

Inclusion Criteria: Children diagnosed with ASD will undergo general examinations by a pediatric neurologist, psychiatrist, and dietitian, and eligible participants will be included in the study. All children will be evaluated by a child and adolescent psychiatrist according to DSM-5 diagnostic criteria, and all will have their neurological evaluations completed by a pediatric neurologist. Children diagnosed with autism spectrum disorder who receive at least two hours of regular special education per week will be included in the study. Special education is crucial for every child diagnosed with ASD. The project team considers the importance of special education for children with ASD. It has been stated that participants who do not receive special education or are not continuing their education will be excluded. However, children's special education hours vary widely. The state provides two hours of special education for diagnosed children. Further hours of education may vary based on family requests. Because each child in this study will be evaluated after three months based on their individual development, it is expected that their education hours will remain constant throughout the study. If each participating child receives two hours of special education during the study, the continuity of these two hours will be monitored. If a change in training hours is detected, participants will be excluded from the study. Analysis will be conducted by adjusting for the effect of training hours to determine the effect of the diet. Individuals who meet the study criteria and voluntarily agree to participate in the study will be provided with an informed consent form. The Childhood Autism Rating Scale (CARS) and the Problem Behavior Checklist (ABC) will be used in the clinical evaluation of all children. These scales will be completed by the same clinician during the initial psychiatric evaluation and immediately after completing the 12-week diet program. Blinding will be applied to the CARS, ABC, gastrointestinal sensitivity index, Bristol stool scale, and serum zonulin and claudin-5 analyses administered to the participants at the beginning and end of the study. Except for the dietitian researcher responsible for explaining and monitoring the nutrition education and diet plan, all other researchers will evaluate the participants in accordance with the blinding principle. Exclusion Criteria: Those under three years of age and over six years of age; Those unable to be fed orally; Patients with height-for-age, weight-for-age, and BMI-for-age Z scores above +2 SD and below -2 SD for their age and gender using World Health Organization growth references; those diagnosed with neurometabolic diseases such as epilepsy, Fragile X syndrome, or Williams syndrome; those who do not continue their special education or do not accept special education; those who are on any dietary treatment, using nutritional supplements and/or medication in the last 2 months; those with diet compliance less than 80%; and those diagnosed with celiac disease and gluten intolerance will be excluded from the study.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The group following a ASD

Group II

Active Comparator
Normal Diet

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Karadeniz Teknik Üniversitesi

Trabzon, Turkey (Türkiye)Open Karadeniz Teknik Üniversitesi in Google Maps
CompletedOne Study Center