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Clinical Trials/NCT02693327
NCT02693327
Completed
Not Applicable

Microbiome and the Gut-Brain Axis

University of Florida2 sites in 1 country58 target enrollmentApril 2016
ConditionsMental Disorder

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mental Disorder
Sponsor
University of Florida
Enrollment
58
Locations
2
Primary Endpoint
The potential differences in gut microbiome profiles between persons diagnosed with a major mental illness vs. healthy controls.
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
September 2017
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Study Sites (2)

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