Microbiome and the Gut-Brain Axis

Completed

• Conditions: Mental Disorder
• Interventions: Other: Biological Sample; Other: Blood Sample

• Registration Number: NCT02693327
• Lead Sponsor: University of Florida

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.

Study Timeline

• Study First Submitted: 2016-02-16
• Study First Submitted QC: 2016-02-22
• Study First Posted: 2016-02-26
• Study Start: 2016-04
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-13
• Last Update Posted: 2018-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-mental illness group	Blood Sample	Participants in this group will provide biological samples to include both stool and blood samples.
Mental illness group	Biological Sample	Participants in this group will provide biological samples to include both stool and blood samples.
Mental illness group	Blood Sample	Participants in this group will provide biological samples to include both stool and blood samples.
Non-mental illness group	Biological Sample	Participants in this group will provide biological samples to include both stool and blood samples.

Primary Outcome Measures

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

Trial Locations

Locations (2)

Department of Psychiatry, Springhill clinic; 🇺🇸 Gainesville, Florida, United States

Department of Medicine, Springhill clinics; 🇺🇸 Gainesville, Florida, United States