Effect of Gluten-free, Casein-free Diet in Children With Autism
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Autism Spectrum Disorder
- Sponsor
- Uskudar University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Weight (kg)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Mesut Karahan
Assoc. Prof.
Uskudar University
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
Outcomes
Primary Outcomes
Weight (kg)
Time Frame: 8 weeks
Body weight was measured in kilograms.
Gilliam Autism Rating Scale 2 (GARS-2)
Time Frame: 8 weeks
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.
Body mass index
Time Frame: 8 weeks
Body mass index (BMI)=weight/(height)\^2
Secondary Outcomes
- The pupil measurements(8 weeks)