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Probiotic Treatment for Adverse Childhood Experiences

N/A
Recruiting
Led By Gesulla Cavanaugh, PhD
Research Sponsored by Nova Southeastern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Children 4-7 years old
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Study Summary

"This trial aims to study how the gut and brain are connected in children with autism and children exposed to repeated stress by analyzing their microbiome and eye-tracking data to understand how stress affects their symptoms."

Who is the study for?
This trial is for children with Autism Spectrum Disorder or those who have experienced repeated stress, including stress fractures and adverse childhood experiences. It aims to compare these groups with a control group of children without these conditions.Check my eligibility
What is being tested?
The study is testing whether taking probiotics can influence the gut microbiome and how this might be associated with stress responses and cognitive functions in children, using advanced techniques like metabolomics and eye-tracking.See study design
What are the potential side effects?
Probiotics are generally considered safe but may cause digestive discomfort, such as gas or bloating, especially when first starting them. Rarely, they could lead to more significant side effects in kids with compromised immune systems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child is between 4 and 7 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Enteric Microbiome abundance
Enteric Microbiome diversity
Secondary outcome measures
Improved physiological response to stressor
Improved response to stressor

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Probiotic TreatmentExperimental Treatment1 Intervention
Pediatric Probiotic Treatment
Group II: No Probiotic TreatmentActive Control1 Intervention
No intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Probiotic
2013
Completed Phase 4
~3570

Find a Location

Who is running the clinical trial?

Nova Southeastern UniversityLead Sponsor
93 Previous Clinical Trials
11,617 Total Patients Enrolled
Gesulla Cavanaugh, PhDPrincipal InvestigatorNova Southeastern University
~39 spots leftby Dec 2025
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