Effect of Gluten-free, Casein-free Diet in Children With Autism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Weight (kg)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Weight (kg)
时间窗: 8 weeks
Body weight was measured in kilograms.
Gilliam Autism Rating Scale 2 (GARS-2)
时间窗: 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
时间窗: 8 weeks
Body mass index (BMI)=weight/(height)\^2
次要结局
- The pupil measurements(8 weeks)
研究者
Mesut Karahan
Assoc. Prof.
Uskudar University