Clinical trial NCT05848336: The Gluten-Casein-free Diet in Children With Autism: A Clinical Results of the Ophthalmic and Behavioral Manifestations
Official title: Effect of Gluten-free, Casein-free Diet in Children With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Ophthalmic Abnormalities
Keywords: gluten free casein free diet
Lead sponsor: Uskudar University
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Gilliam Autism Rating Scale 2 (GARS-2)
timeFrame: 8 weeks
measure: Weight (kg)
timeFrame: 8 weeks
measure: Body mass index
timeFrame: 8 weeks
Secondary outcomes:
measure: The pupil measurements
timeFrame: 8 weeks
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Üsküdar University
Study officials:
References: