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The Path Study: Cognitive and Inflammation Targeted Gut-brain Interventions in Alcohol; Probiotics, Alcohol, Transcutaneous Vagus Nerve Stimulation, and HIV Study
Sponsor: University of Florida
Summary
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.
Official title: Cognitive and Inflammation Targeted Gut-brain Interventions in Alcohol; Probiotics, Alcohol, Transcutaneous Vagus Nerve Stimulation, and HIV Study
Key Details
Gender
All
Age Range
35 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2022-06-01
Completion Date
2026-06-30
Last Updated
2025-06-15
Healthy Volunteers
No
Conditions
Interventions
Probiotic Supplement
Participants will take a probiotic supplement or placebo for 90 days.
Transcutaneous Vagal Nerve Stimulation (tVNS)
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.
Locations (1)
University of Miami
Coral Gables, Florida, United States