NCT05848336

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Uskudar University · Academic / Other
• Sex: All
• Age: 2 Years – 11 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Autism Spectrum Disorder
• Ophthalmic Abnormalities

Interventions

Type	Name	Description
BEHAVIORAL	Gluten Free Casein Free Diet	Thirty children with autism were evaluated before the diet (Pre-Test) and after 8 weeks of dietary intervention (Post-Test).

Timeline

• Start date: 2020-11-26
• Primary completion: 2022-03-14
• Completion: 2023-01-18
• First posted: 2023-05-08
• Last updated: 2023-05-08

Locations

1 site across 1 country: Turkey (Türkiye)