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临床试验/NCT04873674
NCT04873674招募中不适用

A Deep Learning Algorithm Platform to Predict Autism Diagnosis and Subtypes by Integrating Clinical, Cognitive, Imaging, Gut Microbiome, and Metabolome Data

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2020年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
420
试验地点
1
主要终点
Neuropsychological functions: Continuous Performance Test(CPT)

研究概览

简要总结

This is the first human study on ASD microbiome with robust methodologies: prospective and sibling designs, metagenomics profiles, establishing an ASD multi-dimensional databank (clinic, behavior, neurocognition, brain imaging, metabolomics, and microbiome) collected using the same methodology and genetic biology simultaneously, and developing a deep learning platform for ASD diagnosis and prevention. With the accomplishment of this project, we anticipate establishing a web application for clinical and academic use. Our findings will further advance the knowledge in the pathogenetic mechanisms of ASD to enhance early detection, diagnosis, and treatment, subsequently contributing to precision medicine.

详细描述

Due to the high prevalence (1% in Taiwan), long-lasting impairment, unclear etiologies, and a lack of effective detection, prevention, and biological treatment, autism spectrum disorder (ASD) has been prioritized for biomarker, mechanism, and treatment research. Recently the gut-brain-axis has been proved, mainly with animal models, to be altered in psychiatric disorders and notably in ASD. With PI Gau's long-term achievement in ASD multi-dimensional research and our preliminary finding of altered gut microbiota in ASD and their unaffected siblings, we propose this 4-year prospective large-scale study with sibling design and multi-dimensional measures (environmental, clinical, cognitive, imaging, gut microbiome, metabolome) to establish a deep learning algorithm platform for predicting ASD and searching potential biomarkers and probiotic treatment for ASD.

Specific Aims:

  1. To demonstrate the metagenomics profiles analysis based on the gut microbiome and metabolome of ASD patients, unaffected siblings, and typically developing controls (TDC).
  2. To investigate environmental factors such as pregnancy and birth history from the mother's medical records and interviews or national health insurance data, for the microbiome, metagenomics, and brain anatomy and function.
  3. To develop a deep learning algorithm platform using the environmental, behavioral/clinical phenotypes, neurocognitive/imaging endophenotypes, and metagenomics profiles to identify microbiota (metagenomics, too) makers and other predictors for ASD diagnosis, subtypes, and level of impairments.
  4. To establish a web application based on our deep learning algorithm platform for clinical use to assist medical doctors in diagnosing ASD.

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
4 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •ASD participants are (1) they have a clinical diagnosis of ASD defined by the DSM-5 criteria,1 made by board-certificated child psychiatrists and confirmed by the ADI-R/ADOS; (2) their ages range from 4 to 25; (3) both parents are Han Chinese; (4) they and their parents cooperate with all the assessments and stool and blood collection.
  • •Inclusion Criteria for US and TDC are (1) they do not reach the clinical diagnosis of ASD according to DSM-5 diagnostic criteria and the same criteria as described in the (2), (3), (4) and of Inclusion Criteria for ASD participants.

排除标准

  • •(1) comorbidity with DSM-5 diagnoses of schizophrenia, schizoaffective disorder, delusional disorder, other psychotic disorders, organic psychosis, schizotypal personality disorder, bipolar disorder, depression, severe anxiety disorders or substance use; (2) comorbidity with neurological or systemic disorders; and (3) having a first degree relative who may have ASD based on family history method assessment (the TDC group).

结局指标

主要结局

Neuropsychological functions: Continuous Performance Test(CPT)

时间窗: 15 minutes

The 4 dimensions of CCPT: focused attention, hyperactivity/impulsivity, sustained attention, and vigilance

Neuropsychological functions: Cambridge Neuropsychological Test Automated Batteries(CANTAB)

时间窗: 1.5 hours

The 4 main cognitive components of CANTAB: Visual Memory, Attention, Working and Planning Memory (Executive Functions), and Decision Making

Autism diagnostic interview (ADI-R)

时间窗: 4 hours

Including reciprocal social interaction, communication, and repetitive behaviors and stereotyped patterns, for children with a mental age from about 18 months into adulthood

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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