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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nova Southeastern UniversityLead Sponsor

89 Previous Clinical Trials

11,566 Total Patients Enrolled

Gesulla Cavanaugh, PhDPrincipal InvestigatorNova Southeastern University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently able to participate in this ongoing research study?

"Affirmative. The details on clinicaltrials.gov imply that this medical investigation is presently enrolling participants. Initially shared on January 12th, 2023, the trial's most recent update was made on February 13th, 2024. Recruitment aims to include 75 patients from a single site."

Answered by AI

What is the cumulative enrollment count for participants in this clinical investigation?

"Indeed, as indicated on clinicaltrials.gov, this investigation is actively seeking suitable individuals. The trial was first listed on 1/12/2023 and most recently revised on 2/13/2024. Enrollment aims to reach 75 volunteers at a single site."

Answered by AI

Are individuals older than 35 years able to participate in this medical research study?

"Individuals as young as 4 years old, up to a maximum of 95 months old, are eligible for participation according to the specified inclusion criteria for this trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Gesulla Cavanaugh 2023. "Assessing the Gut Microbiome and Its Association With Pediatric Stress and Cognition". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06269614.

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