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| ID | Type | Description | Link |
|---|---|---|---|
| P01AA029543 | U.S. NIH Grant/Contract | View source | |
| PRO00035889 | Other Identifier | UFIRST |
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| Name | Class |
|---|---|
| University of Miami | OTHER |
| University of Louisville | OTHER |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
| Exegi Pharma, LLC |
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This project uses a hybrid trial design to evaluate two biomedical interventions targeting the gut-brain axis. One intervention is portable Transcutaneous Vagus Nerve Stimulator, tVNS, that is hypothesized to stimulate the autonomic nervous system, resulting in decreased inflammation and improved cognition. The second intervention is a probiotic supplement intended to replace gut bacteria that are associated with dysbiosis in persons with HIV and alcohol consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary Supplement (e.g., vitamins, minerals) | Experimental | Visbiome probiotic supplement |
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| Device (including sham) | Active Comparator | Transcutaneous Vagal Nerve Stimulation (tVNS) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic Supplement | Dietary Supplement | Participants will take a probiotic supplement or placebo for 90 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Improved cognition from day 1 to day 90 | Various indices of cognition will be measured using standard neuropsychological tests and neuroimaging at multiple time points and examined for change within subjects. | Baseline up to 90 days |
| Reduction of dysbiosis from day 1 to day 90 | The gut microbiome will be analyzed through stool samples to measure for changes in biodiversity including an increase in beneficial bacteria. | Baseline up to 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emily Carter | Contact | 352-294-5837 | em.carter@phhp.ufl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Eric Porges, PhD | University of Florida | Principal Investigator |
| Robert L Cook, MD | University of Florida | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Recruiting | Coral Gables | Florida | 33146 | United States |
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| INDUSTRY |
| Soterix Medical | INDUSTRY |
This is a 2 x 2 factorial, longitudinal design (tVNS/Sham, Probiotic/Placebo) across three time points (baseline; 30days and 90days).
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This is a 2x2 design in which subjects will be randomly assigned to one of 4 interventions groups: tVNS and probiotic (n=20); tVNS and placebo (n=20), sham stimulator and probiotic (n=20), and sham stimulator and placebo (n=20). We will use a computer-assisted stratified block randomization with block size of 4 to assign participants to the intervention. Study participants, investigators, staff, and physicians administering the probiotics or placebo will be unaware of specific group assignment. The stratified, blocked randomization and assignment of participants to the 4 intervention groups will be guided and monitored by Data Science Core.
| Transcutaneous Vagal Nerve Stimulation (tVNS) | Device | Participants will use a non-invasive stimulator 1 hour daily for 30 days. This stimulator is placed around the ear similar to headphones and produces a very mile electric current. This wellness device is safe to use and painless. Some describe the sensation to be a slight tingle up to a small itch. |
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