Active — Not RecruitingNot Applicable

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

United States75 participantsStarted 2023-01-12

Plain-language 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.

Who can participate

Age range4 Years – 95 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Enteric Microbiome abundance

Timeframe: 4 weeks

Enteric Microbiome diversity

Timeframe: 4 weeks

Trial details

NCT IDNCT06269614

SponsorNova Southeastern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

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