Microbiome and the Gut-Brain Axis

University of Florida58 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Mental Disorder

Interventions

Biological SampleOTHER

A one time sample will be collected.

Blood SampleOTHER

A one time blood sample will be collected.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Department of Medicine, Springhill clinics

Gainesville, Florida, United States

Department of Psychiatry, Springhill clinic

Gainesville, Florida, United States

Outcomes

Primary Outcomes

The potential differences in gut microbiome profiles between persons diagnosed with a major mental illness vs. healthy controls.

In vitro metagenomic sequencing and taxa analyses of gut microbial DNA isolated from stool samples.

Time frame: Baseline

Correlation of blood biomarkers with gut microbiome taxa, comparing persons diagnosed with a major mental illness vs. healthy controls.

In vitro analysis of blood biomarkers including short chain fatty acids, inflammatory markers, and evidence for presence of bacteria.

Time frame: Baseline

Data from ClinicalTrials.gov

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