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

NCT06269614 | Active Not Recruiting

• 1 other identifier: QOL334829
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Adverse Childhood Experiences; Stress Reaction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Improved response to stressor

  4 weeks

• Improved physiological response to stressor

  4 weeks

Study Arms (2)

Probiotic Treatment

EXPERIMENTAL

Pediatric Probiotic Treatment

Dietary Supplement: Probiotic

No Probiotic Treatment

NO INTERVENTION

No intervention

Interventions

Probiotic DIETARY_SUPPLEMENT

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

Probiotic Treatment

Eligibility Criteria

• Age: 4 Years - 95 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Nova Southeastern University: lead

Study Sites (1)

Nova Southeastern University College of Nursing

Davie, Florida, 33314, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Fractures, Stress

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Gesulla Cavanaugh, PhD

  Nova Southeastern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Dean of Research and Assessment

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: February 21, 2024
• Study Start: January 12, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)