Skip to main content
OpenTrials
Completed

NCT Number: NCT05848336

The Gluten-Casein-free Diet in Children With Autism: A Clinical Results of the Ophthalmic and Behavioral Manifestations

To evaluate the efficacy of eight weeks of GFCF in children with ASD on autistic symptoms and ophthalmic findings such as corneal reflex, interpupillary distance (IPD) and pupil size.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders Ophthalmic Abnormalities

Age range

2 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Üsküdar University

Istanbul, 34672, Turkey (Türkiye)

About this study

Autism spectrum disorder (ASD) is a common condition. ASD is a heritable illness characterized by early-onset differences in interaction, communication, sensory atypicality, and stereotyped behaviors. Recent studies suggest a link between elimination diets and severity of autistic behaviors. The etiology of ASD has been still uncertain. Therefore, elucidating the underlying pathology may assist in risk assessment and facilitate process management. Non-harmful and existing evidence for the diet's benefits in ASD must be elucidated.

Primary Study Objective:

To assess the effect of a GFCF diet on variables autism index, stereotyped behaviors, communication, social interaction associated with ASD.

The pupillary response can be utilized to anticipate neurological and physiological activities under the surface. Changes in light trigger the pupil response, which adjusts the amount of brightness falling on the retina by instinctively constricting or dilating the pupil. Atypical pupil size has been linked to abnormal autonomic function in people with ASD. Disturbances in autonomic functions may also lead to differences in the corneal reflex. This study aimed to obtain more data on the behavioral symptoms and ophthalmic measurements of gluten-free casein-free (GFCF) on ASD. In addition, normal development children and children with autism may differ in facial morphology. This study also evaluates the effect of GFCF diet on IPD distance.

Secondary Objectives:

To assess the role of GFCF diet in the manifestation of opthalmic measurements such as pupil size, corneal reflex and IPD.

30 children with ASD were enrolled in a 8-weeks prospective GFCF diet treatment study. In the study, a single group was evaluated with measurements before and after dietary intervention.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent / Assent, as applicable must be signed prior to executing any study related procedure
  • Children, male or female, 2 to 11 years old (inclusive)
  • Confirmed diagnosis of ASD according to the DSM-IV Symptom Checklist
  • Ability to maintain a gluten- and casein-free diet during the study

Exclusion criteria

  • Cardiovascular, psychiatric, autoimmune, cancer, etc. children with secondary different disease
  • Children with any drug use
  • Children currently receiving treatment with any alternative medical methods (eg.hyperbaric).
  • Children with a diagnosis of celiac disease
  • Children who have received any dietary treatment before

Treatment and study plan

Gluten Free Casein Free Diet

Behavioral

Thirty children with autism were evaluated before the diet (Pre-Test) and after 8 weeks of dietary intervention (Post-Test).

Primary outcomes

  1. Gilliam Autism Rating Scale 2 (GARS-2)

    Time frame: 8 weeks

    Based on DSM-IV autism diagnostic criteria, GARS-2 is a behavior checklist for children and teenagers aged 3 to 22. The three subscales of the scale are communication, social interaction, and stereotypical behavior. Each subscale contains 14 items that are scored on a four-point scale (0: Never observed, 1: Rarely observed, 2: Sometimes observed, 3: Often observed). The total score obtained from the scale is converted into standard scores, and an OBI score is obtained. An OBI score of 85 and above indicates a high probability of having ASD, a score between 70-84 indicates a medium probability, and a score of 69 and below indicates a low probability.

  2. Weight (kg)

    Time frame: 8 weeks

    Body weight was measured in kilograms.

  3. Body mass index

    Time frame: 8 weeks

    Body mass index (BMI)=weight/(height)^2

Secondary outcomes

  1. The pupil measurements

    Time frame: 8 weeks

    The measurements of both groups were taken from a distance of 1 meter with a binocular photo refractometer under the same conditions, without cycloplegia. Plusoptix® A09 an measure a pupil size of 4.0-8.0 mm in 0.1 mm steps. Eccentric photorefraction is used as a measurement basis. The device provides convenience in terms of pediatric evaluation with its remarkable features. The pupil measurements were performed by an ophthalmologist in the outpatient clinical unit. The brightness level in the room was controlled via the lux meter application. Pupil size (mm) was measured at least three times after each participant was left in a room with a light level of 8 cd/m2 for 2 minutes. The average value of 3 consecutive consistent measurements was recorded.

Sponsors and collaborators

Lead sponsor

Uskudar University

Other

Registry information

Official study title

Effect of Gluten-free, Casein-free Diet in Children With Autism

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
May 8, 2023
Registry last updated
May 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.