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

Part of paid clinical trials in Coral Gables, Florida.

Sponsor
University of Florida
Study ID
NCT05090267
Status
Recruiting
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Conditions

  • Cognition
  • Gut Microbiome

Eligibility Criteria

Sex
ALL
Age
35 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Probiotic Supplement — DIETARY_SUPPLEMENT
    Participants will take a probiotic supplement or placebo for 90 days.
  • 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.

Study Details

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.

Key Dates

Start date
Jun 1, 2022
Status verified
Jun 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Dietary Supplement (e.g., vitamins, minerals)
    Visbiome probiotic supplement
  • Active Comparator: Device (including sham)
    Transcutaneous Vagal Nerve Stimulation (tVNS)

Primary Outcome Measure

Improved cognition from day 1 to day 90 [ Time Frame: Baseline up to 90 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiCoral GablesFlorida33146
Varan Govind, PhD
[email protected]
305-243-8096
Varan Govind, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Miami· Coral Gables, FL

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