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Could a special diet ease autism symptoms? small trial investigates

NCT ID NCT07274930

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study looked at whether a gluten-free and casein-free diet affects certain blood markers and symptoms in children with autism spectrum disorder. Twenty-one children aged 3-6 were randomly assigned to either the special diet or a normal diet for 12 weeks. Researchers measured changes in gut and brain barrier proteins, autism symptoms, and brain activity.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
gluten-free casein-free diet
What this could lead to
If it works, this diet could help ease some autism-related symptoms and gut issues in children.
What could go wrong
This is a very small, early study with only 21 children, so results may not apply widely. The diet is hard to follow and may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

21 people

The number who actually took part.

Started

Aug 2024

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 6 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Karadeniz Teknik Üniversitesi

    Trabzon, Ortahi̇sar, 61080, Turkey (Türkiye)

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Other studies related to the condition(s) this trial covers.