Microbiome and the Gut-Brain Axis

Overview

This research study will examine the relationship interconnecting medical body health, mental health, and microbes of the digestive tract in persons living with serious mental illnesses,as compared to persons without such disorders. Existing research suggests that interactions between digestive tract microbes and the body may influence brain function circuits, mood, anxiety state, cognition, behavior, and medical physiology.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 2017

Detailed Description

People living with serious mental illnesses have far shorter life expectancy due to various attending medical disorders. Vast knowledge gaps exist regarding microbial taxa responsible for governing various the human states of health or morbidity or interactions with medications. Serious mental illnesses collectively comprise the single largest medical category of life-long disability worldwide. Mounting evidence in humans and in animal models of schizophrenia, post-traumatic stress disorder (PTSD) and related mental illnesses point to gut microbiome-host interactions that may influence brain function circuits, mood, anxiety state, cognition, behavior, as well as generate medical comorbidities. This research study will collect stool samples and blood for in vitro analysis of microbiome and metabolomics.

Interventions

  • Other: Biological Sample
    • A one time sample will be collected.
  • Other: Blood Sample
    • A one time blood sample will be collected.

Arms, Groups and Cohorts

  • Mental illness group
    • Participants in this group will provide biological samples to include both stool and blood samples.
  • Non-mental illness group
    • Participants in this group will provide biological samples to include both stool and blood samples.

Clinical Trial Outcome Measures

Primary Measures

  • The potential differences in gut microbiome profiles between persons diagnosed with a major mental illness vs. healthy controls.
    • Time Frame: Baseline
    • In vitro metagenomic sequencing and taxa analyses of gut microbial DNA isolated from stool samples.
  • Correlation of blood biomarkers with gut microbiome taxa, comparing persons diagnosed with a major mental illness vs. healthy controls.
    • Time Frame: Baseline
    • In vitro analysis of blood biomarkers including short chain fatty acids, inflammatory markers, and evidence for presence of bacteria.

Participating in This Clinical Trial

Inclusion Criteria

  • People with an existing major mental illness, as already diagnosed currently or within the past year by their doctor prior to being consented,
  • Meeting criteria of the fourth or fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV or DSM 5) or ICD-9 or ICD-10;
  • Diagnosed with a cardiovascular disorder.

Exclusion Criteria

  • Probiotic use currently or within 2 months prior to study enrollment,
  • Antibiotic treatment currently or within 2 months prior to study enrollment;
  • Diagnosis of an intellectual disability, pervasive developmental disorder, and/or progressive dementias including Alzheimer's disease.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Florida
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bruce R. Stevens, PhD, Principal Investigator, University of Florida

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