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

Last updated: June 12, 2025
Sponsor: University of Florida
Overall Status: Active - Recruiting

Phase

N/A

Condition

Inflammation

Brain Function

Treatment

Probiotic Supplement

Transcutaneous Vagal Nerve Stimulation (tVNS)

Clinical Study ID

NCT05090267
CED000000532
PRO00035889
P01AA029543
  • Ages 35-70
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 35-70 years

  • English or Spanish speaking

  • Alcohol users

  • Cognitive impairment

  • Current CD4>350

Exclusion

Exclusion Criteria:

  • 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.

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Probiotic Supplement
Phase:
Study Start date:
June 01, 2022
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • University of Miami

    Coral Gables, Florida 33146
    United States

    Active - Recruiting

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