Clinical trial NCT02693327: Microbiome and the Gut-Brain Axis
Official title: Microbiome and the Gut-Brain Axis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Disorder
Keywords: Gut Microbiome
Mental Disorder
Dysbiosis
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2016-02-26
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: The potential differences in gut microbiome profiles between persons diagnosed with a major mental illness vs. healthy controls.
timeFrame: Baseline
measure: Correlation of blood biomarkers with gut microbiome taxa, comparing persons diagnosed with a major mental illness vs. healthy controls.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Department of Medicine, Springhill clinics
state: Florida
city: Gainesville
country: United States
facility: Department of Psychiatry, Springhill clinic
state: Florida
Study officials:
affiliation: University of Florida
name: Bruce R. Stevens, PhD
role: PRINCIPAL_INVESTIGATOR
References: