Microbiome and the Gut-Brain Axis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Mental Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Mental illness group

Participants in this group will provide biological samples to include both stool and blood samples.

Biological Sample

Intervention Type OTHER

A one time sample will be collected.

Blood Sample

Intervention Type OTHER

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.

Biological Sample

Intervention Type OTHER

A one time sample will be collected.

Blood Sample

Intervention Type OTHER

A one time blood sample will be collected.

Interventions

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Biological Sample

A one time sample will be collected.

Intervention Type OTHER

Blood Sample

A one time blood sample will be collected.

Intervention Type OTHER

Other Intervention Names

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Stool Sample

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes