跳至主要内容
临床试验/NCT01675414
NCT01675414已完成不适用

Understanding Gastrointestinal Conditions in Children With ASD

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 131 人开始时间: 2008年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
131
试验地点
1
主要终点
diagnosis of active gastrointestinal disorder/dysfunction based on the medical history reviewed by and the physical examination performed by a pediatric gastroenterologist

研究概览

简要总结

The purpose of this research study is to help us learn if children with Autism Spectrum Disorder (ASD) have gastrointestinal (stomach and intestine) problems more frequently than children without ASD do. The investigators hope to learn if children with ASD and gastrointestinal (GI) disorders have certain Problem Behaviors (PB), such as self-injury and aggression, more than children with ASD but no GI disorders do. The investigators want to learn if the Gastrointestinal Symptoms Questionnaire (GIQ) can help us tell which children with ASD also have gastrointestinal disorders.

Hypothesis 1: Children with ASD exhibit high rates of symptomatic GI dysfunction that are not identified by current diagnostic evaluation.

Hypothesis 2: Painful or discomfort-causing gastrointestinal dysfunctions contribute to an elevated incidence or severity of PB in an identifiable subpopulation of PB-expressing children. The investigators anticipate that the proposed study will raise the standard of medical care for children with ASD by improving current methods of identifying GI dysfunction and determining whether there is a significant relationship between GI dysfunction and PB in this population.

研究设计

研究类型
Observational
观察模型
Cohort

入排标准

年龄范围
2 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children who are ATN Registry subjects between 2 and 17 years old (inclusive)
  • Meet criteria for an ASD according to the diagnostic measures Autism Diagnostic Observation Schedule (ADOS) and DSM-IV Symptom Checklist, which were conducted at an established ATN center within the last 18 months

排除标准

  • Diagnoses of Rett Syndrome, Childhood Disintegrative Disorder, or other genetic disorders (e.g. Fragile X, Down syndrome, etc.).

结局指标

主要结局

diagnosis of active gastrointestinal disorder/dysfunction based on the medical history reviewed by and the physical examination performed by a pediatric gastroenterologist

时间窗: 6 months after initial evaluation by pediatric gastroenterologist

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Harland S. Winter, MD

Director, Pediatric Inflammatory Bowel Disease Center

Massachusetts General Hospital

研究点 (1)

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