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

NCT ID: NCT06269614

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-12
• Study Completion Date: 2026-12-31

Brief Summary

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.

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.

Conditions

Autism Spectrum Disorder; Adverse Childhood Experiences; Stress Reaction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Probiotic Treatment

Pediatric Probiotic Treatment

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

Consumption of probiotic with parent- as tolerated for 4 weeks.

No Probiotic Treatment

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Probiotic

Consumption of probiotic with parent- as tolerated for 4 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 95 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nova Southeastern University

OTHER

Sponsor Role: lead

Responsible Party

Gesulla Cavanaugh

Assistant Dean of Research and Assessment

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gesulla Cavanaugh, PhD

Role: PRINCIPAL_INVESTIGATOR

Nova Southeastern University

Locations

Nova Southeastern University College of Nursing

Davie, Florida, United States

Countries

United States

Other Identifiers

QOL334829

Identifier Type: -

Identifier Source: org_study_id