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

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

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.

Sponsors & Collaborators

• University of Miami

  collaborator OTHER

• University of Louisville

  collaborator OTHER

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• Exegi Pharma, LLC

  collaborator INDUSTRY

• Soterix Medical

  collaborator INDUSTRY

• University of Florida

  lead OTHER

Principal Investigators

• Eric Porges, PhD · University of Florida

• Robert L Cook, MD · University of Florida

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

35 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-01

Primary Completion

2026-06-30

Completion

2026-06-30

FDA Device

Yes

Countries

• United States

Study Locations