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

Description

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

Study Overview

Study Details

Study overview

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.

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

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

Condition
Cognition
Intervention / Treatment

-

Contacts and Locations

Coral Gables

University of Miami, Coral Gables, Florida, United States, 33146

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age 35-70 years
  • * English or Spanish speaking
  • * Alcohol users
  • * Cognitive impairment
  • * Current CD4\>350
  • * Diagnosed major psychiatric illness
  • * Consumption of over 300 drinks in the past 30 days
  • * Recent opioid use
  • * Lifetime history of medically-assisted alcohol detoxification
  • * Inpatient or intensive treatment for addictive behaviors in the past 12 months
  • * MRI contraindications
  • * Current antibiotic treatment
  • * Current probiotic use
  • * Physical impairment precluding motor response or lying still.

Ages Eligible for Study

35 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Florida,

Eric Porges, PhD, PRINCIPAL_INVESTIGATOR, University of Florida

Robert L Cook, MD, STUDY_DIRECTOR, University of Florida

Study Record Dates

2026-06-30