Diet and Behavior in Young Children With Autism
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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New York
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Rochester、New York、美国、14642
- University of Rochester Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：1
Participants will follow a gluten-free and casein-free diet for 18 weeks.
The compliance with the diet was monitored with 24 hour dietary recall and nutritional sufficiency with diet diary analysis.
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Participants will follow a gluten-free and casein-free diet for 18 weeks.
All children received individual EIBI interventions to decrease the confound of different types of therapies.
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有源比较器：2
After established on a gluten free and casein free diet for at least 6 weeks, participants received double blind, placebo controlled challenges containing gluten, casein, gluten+casein, or placebo in a random order.
Data was collected on behavioral and physiologic responses relative to the challenges.
Children remained on the gluten free and casein free diet throughout this period.
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Participants will follow a gluten-free and casein-free diet for 18 weeks.
They will receive double blind placebo controlled challenge snacks that contain gluten, casein, gluten+casein or placebo with measurement of response.
They remain on the gluten free and casein free diet for the entire study period.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Safety and efficacy of the gluten free casein free diet
大体时间：Measured at Weeks 6,18 and 30
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Behavioral data: activity, sleep, behaviors related to the autism; Medical data: stool pattern, nutrition
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Measured at Weeks 6,18 and 30
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合作者和调查者
调查人员
- 首席研究员：Susan Hyman, MD、University of Rochester
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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