Microbiota-Diversity Enhancing Diet on Children With Autism Spectrum Disorder: The MIND-DASE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Changes in ATEC scores in diet (study) and non-diet (control) ASD participants from baseline to 1 year period.
研究概览
简要总结
Our dietary diversity has changed day by day in industrial age. A low dietary diversity may alter gut microbiota diversity and functional capacity. Wrong messages sourced from gut microbiota were speculated to have a bad influence on autism spectrum disorder (ASD) severity. A new nutritional model aiming to increase microbiota diversity in children with ASD can improve social and communicative behaviors in these children. The investigators compared 220 ASD patients who regularly followed a specific diet program for at least 12 months with randomly selected 100 children with ASD who did not have diet compliance in terms of nutritional status and regular behavioral assessments with special scales (ATEC, ABC, QoLA-P scales). The investigators arised a question that the Microbiota-Diversity Enhancing Diet on Children with ASD (MIND-DASE) which is a specific dietary intervention may have benefits on the neurodevelopmental outcomes of children with ASD.
详细描述
Since industrialization has altered human diet models, we faced with a low dietary diversity, reduced gut microbiota diversity and functional capacity day by day. These changes in gut microbiota have been speculated to associate with severity of autism spectrum disorder (ASD). The investigators researched the possible therapeutic effects of a new nutritional model aiming to increase microbiota diversity in children with ASD. Question is: Can we improve social and communicative behaviors in children with ASD by increasing microbiota diversity through a specific diet? A total of 2000 children diagnosed with ASD and followed in Autism Nutrition Research Center in investigators' hospital were screened: a) a total of 220 participants aged between 2-18 years who regularly followed the specific diet program for at least 12 months were identified as a study group, and b) randomly selected 100 children with ASD who did not have diet compliance were identified as control group. Assessments included dietary adherence and behavioral evaluations using baseline, 6th and 12th month Autism Treatment and Evaluation Checklist (ATEC), Aberrant Behavior Checklist (ABC), The Quality of Life in Autism Questionnaire- Parent version (QoLA-P) scales. The investigators compared diet and non-diet groups by evaluating demographic data, clinical symptoms, diet compliance status and ATEC, ABC, and QoLA-P scores in 12-month time period. The investigators foced on The Microbiota-Diversity Enhancing Diet on Children with ASD (MIND-DASE) which is a specific dietary intervention may have significant benefits on the neurodevelopmental outcomes of children with ASD.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals who were diagnosed ASD by a pediatric psychiatrist or a pediatric neurologist according to the DSM-V criteria
- •Having continued follow-up in our center at least 12 months regularly
- •Being between the ages of 2-18
排除标准
- •Having a genetic syndrome (such as Rett, Angelman syndrome)
- •Having an additional chronic disease
- •Following a different diet program other than our center
结局指标
主要结局
Changes in ATEC scores in diet (study) and non-diet (control) ASD participants from baseline to 1 year period.
时间窗: From enrollment to the end of 12-month time period
ATEC scores will be evaluated by a specialist psychiatric nurse in both groups. ATEC is a parent-completed questionnaire and has four subscales. A total score, which ranges from 0-179 points, is calculated from combined scores of each subscale. A lower ATEC score indicates improvement of ASD symptoms and a higher score correlates with more severe symptoms.
Changes in ABC scores in diet (study) and non-diet (control) ASD participants from baseline to 1 year period.
时间窗: From enrollment to the end of 12-month time period
ABC scores will be evaluated by a specialist psychiatric nurse in both groups. ABC is a scale for determining the behavioral problems in ASD children. It consists of 5 subscales and 58 items. Each item is rated on a four-point scale ranging from 0 (not a problem) to 3 (the problem is severe). Evaluation is based on the scores obtained from the subscales; minimum 0 points to maximum 174 points.
Changes QoLA-P scores in diet (study) and non-diet (control) ASD participants from baseline to 1 year period.
时间窗: From enrollment to the end of 12-month time period
The QoLA-P scores will be evaluated by a specialist psychiatric nurse in both groups. QoLA-P is designed as two subscales: Section A evaluates parent's perceptions about their own QoL, and section B measures the perceptions of parent's problems lived with an autistic child. Total score from this questionnaire ranges from 48 to 240 and higher scores show lesser severity effect.
次要结局
- Height status in diet and non-diet group(From enrollment to the end of 12-month time period)
- Weight status in diet and non-diet group(From enrollment to the end of 12-month time period)
研究者
Hasan Onal, MD
Prof M.D.
Kanuni Sultan Suleyman Training and Research Hospital