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

NCT05848336 | Completed

• 1 other identifier: UskudarUGFCFAUTISM
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Ophthalmic Abnormalities

Keywords

gluten free casein free diet

Outcome Measures

Primary Outcomes (3)

• Gilliam Autism Rating Scale 2 (GARS-2)

  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.

  8 weeks

• Weight (kg)

  Body weight was measured in kilograms.

  8 weeks

• Body mass index

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

  8 weeks

Secondary Outcomes (1)

• The pupil measurements

  8 weeks

Study Arms (1)

Gluten Free Casein Free Diet

EXPERIMENTAL

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.

Behavioral: Gluten Free Casein Free Diet

Interventions

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).

Gluten Free Casein Free Diet

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uskudar University: lead

Study Sites (1)

Üsküdar University

Istanbul, 34672, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 8, 2023
• Study Start: November 26, 2020
• Primary Completion: March 14, 2022
• Study Completion: January 18, 2023
• Last Updated: May 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)