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Microbiome and the Gut-Brain Axis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02693327
Recruitment Status : Completed
First Posted : February 26, 2016
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment
Mental Disorder Other: Biological Sample Other: Blood Sample

Detailed 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.

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Study Type : Observational
Actual Enrollment : 58 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Microbiome and the Gut-Brain Axis
Study Start Date : April 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

Group/Cohort Intervention/treatment
Mental illness group
Participants in this group will provide biological samples to include both stool and blood samples.
Other: Biological Sample
A one time sample will be collected.
Other Name: Stool Sample

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

Non-mental illness group
Participants in this group will provide biological samples to include both stool and blood samples.
Other: Biological Sample
A one time sample will be collected.
Other Name: Stool Sample

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




Primary Outcome Measures :
  1. The potential differences in gut microbiome profiles between persons diagnosed with a major mental illness vs. healthy controls. [ Time Frame: Baseline ]
    In vitro metagenomic sequencing and taxa analyses of gut microbial DNA isolated from stool samples.

  2. Correlation of blood biomarkers with gut microbiome taxa, comparing persons diagnosed with a major mental illness vs. healthy controls. [ Time Frame: Baseline ]
    In vitro analysis of blood biomarkers including short chain fatty acids, inflammatory markers, and evidence for presence of bacteria.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02693327


Locations
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United States, Florida
Department of Medicine, Springhill clinics
Gainesville, Florida, United States, 32610
Department of Psychiatry, Springhill clinic
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Bruce R. Stevens, PhD University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02693327    
Other Study ID Numbers: IRB201500409
First Posted: February 26, 2016    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
Gut Microbiome
Mental Disorder
Dysbiosis
Additional relevant MeSH terms:
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Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders