Actively Recruiting

Phase Not Applicable
Age: 35Years - 70Years
All Genders
NCT05090267

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

Led by University of Florida · Updated on 2025-06-15

80

Participants Needed

1

Research Sites

212 weeks

Total Duration

On this page

Sponsors

U

University of Florida

Lead Sponsor

U

University of Miami

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 35Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 35-70 years
  • English or Spanish speaking
  • Alcohol users
  • Cognitive impairment
  • Current CD4 greater than 350
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Miami

Coral Gables, Florida, United States, 33146

Actively Recruiting

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Research Team

E

Emily Carter

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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