NCT04869930Unknown不适用
Establishing a Diagnostic and Therapeutic Index in Autism Spectrum Disorder (ASD) and Fragile X Syndrome
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- microbial diversity profile
研究概览
简要总结
The purpose of this study is to accumulate and quantitatively analyze data on the microbiome, serotonin signaling and genetics, and inflammatory cytokines from patients with Autism Spectrum Disorder and Fragile X Syndrome. Computational analysis of multi-dimensional datasets will be used to establish a "Diagnostic and Therapeutic Index" - an objective set of tools that can help differentiate subtypes of Autism Spectrum Disorder and develop more accurate methods of diagnosis and response to treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Months 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Early childhood (pre-diagnosis) OR existing ASD diagnosis (Moderate to Severe)
- •Existing FXS diagnosis
排除标准
- •Hospitalization
- •Enrolled in another clinical study
结局指标
主要结局
microbial diversity profile
时间窗: 2 years
genetic analysis of microbial species in fecal samples
次要结局
- differences in serotonin levels(2 years)
- differential expression of serotonin-related signaling molecules(2 years)
研究者
研究点 (1)
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