Microbiome and the Gut-Brain Axis

University of Florida

Status: Completed

Conditions: Mental Disorder

Treatments: Other: Biological Sample; Other: Blood Sample

Study type: Observational

Funder types: Other

Identifiers

NCT02693327

IRB201500409

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

58 participants in 2 patient groups

Mental illness group

Description:

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

Treatment:

Other: Blood Sample

Other: Biological Sample

Non-mental illness group

Description:

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

Treatment:

Other: Blood Sample

Other: Biological Sample