search
Back to results

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

Primary Purpose

Autism Spectrum Disorder, Ophthalmic Abnormalities

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Gluten Free Casein Free Diet
Sponsored by
Uskudar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring gluten free casein free diet

Eligibility Criteria

2 Years - 11 Years (Child)All SexesAccepts 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

Sites / Locations

  • Üsküdar University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gluten Free Casein Free Diet

Arm 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.

Outcomes

Primary Outcome Measures

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.
Weight (kg)
Body weight was measured in kilograms.
Body mass index
Body mass index (BMI)=weight/(height)^2

Secondary Outcome Measures

The pupil measurements
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.

Full Information

First Posted
April 26, 2023
Last Updated
May 5, 2023
Sponsor
Uskudar University
search

1. Study Identification

Unique Protocol Identification Number
NCT05848336
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 26, 2020 (Actual)
Primary Completion Date
March 14, 2022 (Actual)
Study Completion Date
January 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uskudar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Ophthalmic Abnormalities
Keywords
gluten free casein free diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gluten Free Casein Free Diet
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Gluten Free Casein Free Diet
Intervention Description
Thirty children with autism were evaluated before the diet (Pre-Test) and after 8 weeks of dietary intervention (Post-Test).
Primary Outcome Measure Information:
Title
Gilliam Autism Rating Scale 2 (GARS-2)
Description
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.
Time Frame
8 weeks
Title
Weight (kg)
Description
Body weight was measured in kilograms.
Time Frame
8 weeks
Title
Body mass index
Description
Body mass index (BMI)=weight/(height)^2
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
The pupil measurements
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Üsküdar University
City
İstanbul
ZIP/Postal Code
34672
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs