The Path Study: Cognitive and Inflammation Targeted Gut-brain Interventions in Alcohol; Probiotics, Alcohol, Transcutaneous Vagus Nerve Stimulation, and HIV Study

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.

NCT Number	NCT05090267
Lead Sponsor	University of Florida Collaborators: University of Miami, University of Louisville, National Institute on Alcohol Abuse and Alcoholism (NIAAA), Exegi Pharma, LLC, Soterix Medical
Conditions	Cognition, Gut Microbiome
Enrollment	80 participants
Start Date	2022-06-01
Primary Completion	2026-12-30 (estimated)
Study Completion	2026-12-30 (estimated)
Updated on ClinicalTrials.gov	2026-08-06