Microbiome and the Gut-Brain Axis

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 Overview

• Status: Completed
• Conditions: Mental Disorder
• Intervention / Treatment: Other: Biological Sample; Other: Blood Sample

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.

• Study Type: Observational
• Enrollment (Actual): 58

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • Department of Medicine, Springhill clinics
    • Gainesville, Florida, United States, 32610
      • Department of Psychiatry, Springhill clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Group 1 will have a diagnosis of a mental illness. Group 2 will not have a diagnosis of mental illness.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mental illness group; Participants in this group will provide biological samples to include both stool and blood samples.	Other: Biological Sample; A one time sample will be collected.; Other Names: Stool Sample; Other: Blood Sample; A one time blood sample will be collected.
Non-mental illness group; Participants in this group will provide biological samples to include both stool and blood samples.	Other: Biological Sample; A one time sample will be collected.; Other Names: Stool Sample; Other: Blood Sample; A one time blood sample will be collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Bruce R. Stevens, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: February 16, 2016
• First Submitted That Met QC Criteria: February 22, 2016
• First Posted (Estimate): February 26, 2016

Study Record Updates

• Last Update Posted (Actual): June 15, 2018
• Last Update Submitted That Met QC Criteria: June 13, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Gut Microbiome; Mental Disorder; Dysbiosis
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: IRB201500409

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No