Microbiome Determinants of Neurological and Gastrointestinal Symptoms of Autism Spectrum Disorder (ASD)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Prevalence of species in samples from people with ASD
研究概览
简要总结
This observational study aims to identify human microbiome determinants of the symptoms associate with ASD as well as identify the human microbiome determinants of the success of FMT (fecal matter transplant) therapy and to develop a statistical model that can improve FMT donor-recipient matching. Participants are recruited through NovelBiome only, this study will NOT utilize other clinical sites.
详细描述
This longitudinal, observational study aims to identify human microbiome determinants of the symptoms associate with ASD as well as identify the human microbiome determinants of the success of FMT therapy and to develop a statistical model that can improve FMT donor-recipient matching.
Participant phenotype data and samples are collected at several time points relative to their receiving FMT therapy.
Participants will collect stool, urine, environmental swabs, saliva, and blood at home via VLS's (Viome Life Sciences) at-home kits mailed to them by VLS. The at-home samples are collected by participants (and when appropriate LAR/guardian). The samples are then returned to VLS via postage-paid mailers (provided). These samples are analyzed by the VLS laboratory.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ASD, from medical records, self-diagnosed and/or LAR reported (LAR = legally authorized representative)
- •Plans to undergo FMT treatment at a Novel Biome Clinic
- •Consented to participate in the study
排除标准
- •Active cancer therapy
- •Antibiotic use within 30 days prior to starting the FMT therapy. FMT therapy itself starts with antibiotic treatment.
结局指标
主要结局
Prevalence of species in samples from people with ASD
时间窗: 10 years
Prevalence of species in samples from people with ASD compared to non-ASD samples
Prevalence of species in samples that led to successful FMT therapy
时间窗: 10 years
Prevalence of species in samples that led to successful FMT therapy
次要结局
未报告次要终点