Microbiome and the Gut-Brain Axis

Study Overview
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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.

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.

Official Title
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Microbiome and the Gut-Brain Axis

Conditions
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Mental Disorder

Intervention / Treatment
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* Other: Biological Sample
* Other: Blood Sample


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mental illness group<br>Participants in this group will provide biological samples to include both stool and blood samples. | Other: Biological Sample<br>* A one time sample will be collected.<br>* Other names: Stool Sample;Other: Blood Sample<br>* A one time blood sample will be collected.<br>|
| Non-mental illness group<br>Participants in this group will provide biological samples to include both stool and blood samples. | Other: Biological Sample<br>* A one time sample will be collected.<br>* Other names: Stool Sample;Other: Blood Sample<br>* A one time blood sample will be collected.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The potential differences in gut microbiome profiles between persons diagnosed with a major mental illness vs. healthy controls. | In vitro metagenomic sequencing and taxa analyses of gut microbial DNA isolated from stool samples. | Baseline | 
| Correlation of blood biomarkers with gut microbiome taxa, comparing persons diagnosed with a major mental illness vs. healthy controls. | In vitro analysis of blood biomarkers including short chain fatty acids, inflammatory markers, and evidence for presence of bacteria. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gut Microbiome, Mental Disorder, Dysbiosis