Microbiome and the Gut-Brain Axis

NCT02693327 | Completed DMC

• 1 other identifier: IRB201500409
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 2

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.

Conditions

Mental Disorder

Keywords

Gut Microbiome; Mental Disorder; Dysbiosis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Mental illness group

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

Other: Biological Sample; Other: Blood Sample

Non-mental illness group

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

Other: Biological Sample; Other: Blood Sample

Interventions

Biological Sample OTHER

A one time sample will be collected.

Also known as: Stool Sample

Mental illness group; Non-mental illness group

Blood Sample OTHER

A one time blood sample will be collected.

Mental illness group; Non-mental illness group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Group 1 will have a diagnosis of a mental illness. Group 2 will not have a diagnosis of mental illness.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (2)

Department of Medicine, Springhill clinics

Gainesville, Florida, 32610, United States

Location

Department of Psychiatry, Springhill clinic

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Mental Disorders; Dysbiosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Bruce R. Stevens, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2016
• First Posted: February 26, 2016
• Study Start: April 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: June 15, 2018

Record last verified: 2018-06

Locations

US (2)