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临床试验/NCT05794620
NCT05794620已完成不适用

Faecal Microbiota Analysis in Neurotypical and Autism Syndrome Disorder Siblings: FAMILY

East Suffolk and North Essex NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年12月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Gut microbiota

研究概览

简要总结

This study aims to accurately characterise the gut microbiota composition of faeces of children with ASD and compare it with the gut microbiota composition of their neurotypical siblings. In addition it aims to also characterise the metagenome and metabolome of the faeces of both ASD and neurotypical siblings.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
3 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children of both sexes who are diagnosed with ASD and under the care of ESNEFT who have a neurotypical sibling (either full or half sibling), who share their living environment. This is due to the study requiring stool samples that are from siblings, to control for genes and environment where possible.
  • Aged 3 years to 10 years old (at time of consent)
  • Parent/guardian able to consent to participate
  • Parent/guardian able to complete required surveys (or with accommodated adjustments)

排除标准

  • Use of antibiotics in the previous 4 weeks
  • Not under the care of ESNEFT
  • Children <3 years old and >10 years old
  • Children that don't have half or full siblings
  • Parent/guardian unable to provide informed consent or complete surveys, despite reasonable adjustments being implemented

研究组 & 干预措施

Children with Autism

A child with a diagnosis of Autism

干预措施: Stool sample (Other)

Neurotypical siblings

A full sibling of the child with Autism

干预措施: Stool sample (Other)

结局指标

主要结局

Gut microbiota

时间窗: 0 weeks

Gut microbiota composition of faeces of children with ASD

次要结局

未报告次要终点

研究者

发起方
East Suffolk and North Essex NHS Foundation Trust
申办方类型
Other
责任方
Sponsor

研究点 (1)

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