跳至主要内容
临床试验/NCT06269614
NCT06269614进行中(未招募)不适用

A Multilevel Approach to Assess the Involvement of Gut Microbiome in Autism and Childhood Stress Regulation

Nova Southeastern University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2023年1月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
75
试验地点
1
主要终点
Enteric Microbiome abundance

研究概览

简要总结

Using a metabolomics approach in combination with eye-tracking data, this research study proposes to gather evidence from two interrelated body systems (gut and brain) in order to assess how the microbiome is involved in stress modulated symptoms in children with autism and children exposed to repeated stress in comparison to a control group.

详细描述

The purpose of this study is to find out more about stress in children with autism and those who had negative experiences as children. This will help to find new ways to create therapies against stress on children with autism and those from disadvantaged backgrounds. This study is important because Adverse Childhood Experiences events put children at risk for many health issues. The aims include the examination of the involvement of the microbiome in autistic behaviors and as a modulator and response to stress in the pediatric population.

This study is significant in that many studies point to the gut microbiota as a significant mediator to brain function and behavior, while gut microbiome has been found to play a role in stress mediation. In general, microbiome studies in humans are still minimal and are even more lacking in autism and pediatric research; nonetheless, they have facilitated the evaluation of the potential connection between the microbiome and brain function. For these reasons, this research study is even more relevant in the formation of targeted and feasible strategies to find external and internal factors responsible in the buffering of stress in children from disadvantaged backgrounds, and those with autism.

The children who participate in this study will be assessed at two time points; the second time will be after 4-6 weeks from our first meeting. The parent will make the first appointment with the researcher to allow the child take part of the study. The parent will be given a survey to complete on the child and the parent. The parent will also be provided with a stool collection kit. This kit will be used for them to collect stool sample from the participating child before they come to the first and second appointments with the researcher.

The child will watch a short 2-minute video of a medium stressful scenario followed by a fun video. The child will watch the short video while the researchers evaluate the child's interest through their eye movement with an eye tracker on the computer. The child's heart rate will be measured using a Fingertip Pulse Oximeter.

During the first visit with the researcher, the parent will also receive a coupon and instructions to purchase Garden of Life Children's probiotics at the grocery store if they want their child to incorporate the probiotics in their diet for 4 weeks. They will receive instructions for the child to eat more fruits and vegetables after consulting with the child's pediatrician and/or specialist. The parent can have the researcher's recommended children's probiotics, multivitamins, more fruits and vegetables in the child's diet for 4 weeks before returning to the lab for a second observation. The child will again provide spit and stool after the 4 weeks which will be brought back to the lab during the second appointment.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
4 Years 至 95 Months(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Children diagnosed with Autism
  • •Children with neurotypical development
  • •Children in foster care
  • •Children in homeless shelters
  • •Children 4-7 years old
  • •Must be able to watch a short video
  • •Must be able to consume children's powder probiotics for 4 weeks

排除标准

  • •Children younger than 4, and older than 7.9 years old.
  • •Inability to watch a screen
  • •severe cognitive impairment

研究组 & 干预措施

Probiotic Treatment

Experimental

Pediatric Probiotic Treatment

干预措施: Probiotic (Dietary Supplement)

No Probiotic Treatment

No Intervention

No intervention

结局指标

主要结局

Enteric Microbiome abundance

时间窗: 4 weeks

Increase in gut microbiome abundance (from stool samples) based on values from statistical methods, Analysis of Variance to compare differential abundance analysis.

Enteric Microbiome diversity

时间窗: 4 weeks

Increase in gut microbiome diversity in the number of beneficial bacteria in the gut (from stool samples) as measured by α-diversity measures using plot\_anova\_diversity function in microbiomeSeq package.

次要结局

  • Improved response to stressor(4 weeks)
  • Improved physiological response to stressor(4 weeks)

研究者

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

Gesulla Cavanaugh

Assistant Dean of Research and Assessment

Nova Southeastern University

研究点 (1)

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