Cognitive and Inflammation Targeted Gut-brain Interventions in Alcohol; Probiotics, Alcohol, Transcutaneous Vagus Nerve Stimulation, and HIV Study
Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 70
Healthy Volunteers: f
View:
• Age 35-70 years
• English or Spanish speaking
• Alcohol users
• Cognitive impairment
• Current CD4\>350
Locations
United States
Florida
University of Miami
RECRUITING
Coral Gables
Contact Information
Primary
Emily Carter
em.carter@phhp.ufl.edu
352-294-5837
Time Frame
Start Date: 2022-06-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 80
Treatments
Experimental: Dietary Supplement (e.g., vitamins, minerals)
Visbiome probiotic supplement
Active_comparator: Device (including sham)
Transcutaneous Vagal Nerve Stimulation (tVNS)
Related Therapeutic Areas
Sponsors
Collaborators: University of Miami, Soterix Medical, National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Louisville, Exegi Pharma, LLC
Leads: University of Florida