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

Uskudar University

Status: Completed

Conditions: Autism Spectrum Disorder; Ophthalmic Abnormalities

Treatments: Behavioral: Gluten Free Casein Free Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05848336

UskudarUGFCFAUTISM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 2 to 11 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Gluten Free Casein Free Diet

Experimental group

Description:

Foods containing gluten (pasta, bread, etc.), casein (unfermented dairy products), and their disguised sources have been eliminated from the nutrition program. Also, packaged foods (chocolate, crackers, etc.) containing additives such as artificial preservatives, food coloring, and sweeteners that create a tendency to consume in children were avoided from the nutrition program. Goat milk contains type A2 casein, and most of the casein is digested in fermented dairy products. In order to increase calcium intake, the consumption of some foods (dill, kale, spinach, chard, arugula, broccoli, parsley, legumes, nuts, tahini, etc.) has been increased. Elimination was done gradually, considering nervousness, anxiety, etc., due to the effects of opioid mechanisms of action and gastrointestinal system symptoms.

Treatment:

Behavioral: Gluten Free Casein Free Diet