Diet and Behavior in Young Children With Autism
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Safety and efficacy of the gluten free casein free diet
研究概览
简要总结
This study will determine whether a gluten- and casein-free diet has specific benefits for children with autism.
详细描述
Autism is a serious brain disorder that affects brain development and often causes social and educational problems. Prior studies suggested that a gluten- and casein-free diet may have a therapeutic effect on the behavior of children with autism. This study will examine the effects of such a diet on the behavior of children with autism who meet research diagnostic criteria, are monitored in adherence to the diet, and receive similar intense behavioral therapy.
Children in this study will be following a gluten free and casein free diet for 18 weeks. All subjects will have 6 weeks of baseline followed by 12 weeks of randomized, double-blind, placebo-controlled, challenge snacks with careful behavioral observation and evaluation. They also will be receiving uniform educational and behavioral services through their provider. Standard autism evaluation methods, weekly diet and sleep diaries and scheduled laboratory tests will be used to assess subjects. An end of study, follow-up assessment will be completed at 30 weeks after the start of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Months 至 54 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Autism spectrum disorder or pervasive developmental disorder, ADI-R and ADOS positive.
- •Participation in applied behavioral analysis classes for at least 4 months, with at least 10 hours per week of service, and at least 1 hour of service in the home
- •A score higher than 30 on the Mullen Early Learning scale
- •Ability to maintain a gluten- and casein-free diet during the study
- •In order to maintain study integrity, and due to frequent child assessments, enrollment is limited to a select population within the Rochester area
排除标准
- 未提供
结局指标
主要结局
Safety and efficacy of the gluten free casein free diet
时间窗: Measured at Weeks 6,18 and 30
Behavioral data: activity, sleep, behaviors related to the autism; Medical data: stool pattern, nutrition
次要结局
未报告次要终点
研究者
susan hyman
Professor
University of Rochester