Mental DisorderNCT02693327
Microbiome and the Gut-Brain Axis
An observational study of Mental Disorder, run by University of Florida at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Disorder
- What is being tested?
- Biological Sample and Blood Sample
- How many people
- 58 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2016to Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Group 1 will have a diagnosis of a mental illness. Group 2 will not have a diagnosis of mental illness.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Department of Medicine, Springhill clinics
Gainesville, Florida, 32610
Department of Psychiatry, Springhill clinic
Gainesville, Florida, 32610
About this study
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.
Read the 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.
- Conditions
- Mental Disorder
- Being tested
- Biological Sample, Blood Sample
- Keywords
- Gut Microbiome, Mental Disorder, Dysbiosis
- Medical subject headings
- Mental Disorders, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological SampleOther
Also called Stool Sample
A one time sample will be collected.
Blood SampleOther
A one time blood sample will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Mental illness group | Participants in this group will provide biological samples to include both stool and blood samples. Receives: 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. Receives: Other: Biological Sample; Other: Blood Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startApr 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruce R. Stevens, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693327
- Sponsor's protocol ID
- IRB201500409
- Status last verified
- Jun 2018
- First submitted
- 16 Feb 2016
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome and the Gut-Brain Axis
- ClinicalTrials.gov ID
- NCT02693327
- Acronym / sponsor ID
- IRB201500409
- Conditions
- Mental Disorder
- Keywords
- Gut Microbiome, Mental Disorder, Dysbiosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 26 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mental illness group | – | Other: Biological Sample, Other: Blood SampleParticipants in this group will provide biological samples to include both stool and blood samples. |
| Non-mental illness group | – | Other: Biological Sample, Other: Blood SampleParticipants in this group will provide biological samples to include both stool and blood samples. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1 will have a diagnosis of a mental illness. Group 2 will not have a diagnosis of mental illness.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological SampleAlso: Stool SampleA one time sample will be collected. | Other | Mental illness group, Non-mental illness group |
| Blood SampleA one time blood sample will be collected. | Other | Mental illness group, Non-mental illness group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce R. Stevens, PhD principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Disorder, run by University of Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The potential differences in gut microbiome profiles between persons diagnosed with a major mental illness vs. healthy controls. (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2018.