NCT01625299已完成不适用
PILOT STUDY: The Physiological Basis for Dietary Protein Intolerance in Children With Autism
The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2008年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Intestinal Permeability
研究概览
简要总结
We hypothesize that in children with autism dietary antigens can change the intestine, making it "leaky" and then affecting the brain changing their behavior.
详细描述
Subjects in 2 different diets (gluten/dairy and placebo) will be monitored for changes in intestinal permeability (urine lactulose mannitol ratio) and behavior (psychometric testing).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between the ages of 3 and 12 years,
- •DSM-IV (APA, 2000) diagnosis of Autistic Disorder (DSM-IV 299.90),
- •willingness to follow and maintain a gluten-free-dairy-free-diet for 4 weeks.
排除标准
- •food allergies,
- •celiac disease,
- •inflammatory bowel disease,
- •infectious gastrointestinal,
- •seizure disorder,
- •neurological problems with behavioral changes,
- •unwillingness to undertake the dietary challenge with milk and gluten or to maintain a gluten-free-dairy-free-diet during the study were excluded
结局指标
主要结局
Intestinal Permeability
时间窗: baseline, 2 weeks and 4 weeks
Changes in intestinal permeability and behavior with changes in diet
次要结局
- Psychometric testing(baseline, 2 weeks and 4 weeks)
- Gastrointestinal symptoms(baseline, week 2, week 4)
研究者
Fernando Navarro
Assistant Professor
The University of Texas Health Science Center, Houston
研究点 (2)
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