Microbiome and the Gut-Brain Axis

Mental Disorder Clinical Trial

Official title:

Microbiome and the Gut-Brain Axis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02693327
• Other study ID #: IRB201500409
• Status: Completed
• Start date: April 2016
• Est. completion date: September 2017

Study information

• Verified date: June 2018
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorder
• Mental Disorders
• Psychotic Disorders

Intervention

Other:
• Biological Sample
A one time sample will be collected.
• Blood Sample
A one time blood sample will be collected.

Locations

Country	Name	City	State
United States	Department of Medicine, Springhill clinics	Gainesville	Florida
United States	Department of Psychiatry, Springhill clinic	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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