NCT05090267

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 35 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cognition
• Gut Microbiome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic Supplement	Participants will take a probiotic supplement or placebo for 90 days.
DEVICE	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.

Timeline

• Start date: 2022-06-01
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2021-10-22
• Last updated: 2025-06-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study