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Microbiome and the Gut-Brain Axis

Microbiome and the Gut-Brain Axis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02693327
Enrollment
58
Registered
2016-02-26
Start date
2016-04-30
Completion date
2017-09-30
Last updated
2018-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Disorder

Keywords

Gut Microbiome, Mental Disorder, Dysbiosis

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.

Interventions

A one time sample will be collected.

OTHERBlood Sample

A one time blood sample will be collected.

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The potential differences in gut microbiome profiles between persons diagnosed with a major mental illness vs. healthy controls.BaselineIn 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.BaselineIn vitro analysis of blood biomarkers including short chain fatty acids, inflammatory markers, and evidence for presence of bacteria.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026