Microbiome and the Gut-Brain Axis

Completed

Conditions studied: Mental Disorder

In brief

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.

Key facts

Study ID

NCT02693327

Run by

University of Florida

People needed

58

Starts

2016-04-01

Expected to finish

2017-09-01

Last updated by the study team

2018-06-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Department of Medicine, Springhill clinics — Gainesville, Florida, United States
• Department of Psychiatry, Springhill clinic — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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