Assessing the Gut Microbiome and Its Association With Pediatric Stress and Cognition

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Autism Spectrum Disorder; Stress Reaction; Adverse Childhood Experiences
• Intervention / Treatment: Dietary supplement: Probiotic

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Davie, Florida, United States, 33314
      • Nova Southeastern University College of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic Treatment; Pediatric Probiotic Treatment	Dietary supplement: Probiotic; Consumption of probiotic with parent- as tolerated for 4 weeks.
No Intervention: No Probiotic Treatment; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enteric Microbiome abundance	Increase in gut microbiome abundance (from stool samples) based on values from statistical methods, Analysis of Variance to compare differential abundance analysis.	4 weeks
Enteric Microbiome diversity	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.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improved response to stressor	Improved regulated stress response as assessed by salivary cortisol levels from collected saliva while watching the video stressor and the relaxation video (before the probiotics intervention and after the probiotics intervention). Cortisol levels are measured in ug/dL.	4 weeks
Improved physiological response to stressor	Improved physiological response to stressor as measured by pulse rate (bpm) and galvanic skin response (peaks) simultaneously (before and after the probiotics intervention).	4 weeks

Collaborators and Investigators

• Sponsor: Nova Southeastern University
• Investigators: Principal Investigator: Gesulla Cavanaugh, PhD, Nova Southeastern University

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: February 13, 2024
• First Posted (Actual): February 21, 2024

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Wounds and Injuries; Fractures, Bone; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Fractures, Stress; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Probiotics
• Other Study ID Numbers: QOL334829

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be shared based on institutional and IRB approval

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No