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

RecruitingNAAges 35 Years - 70 YearsAllUniversity of Florida
NCT05090267 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 35-70 years * English or Spanish speaking * Alcohol users * Cognitive impairment * Current CD4\>350 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.
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What it tests

  • Probiotic Supplement
  • Transcutaneous Vagal Nerve Stimulation (tVNS)
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Where

1 site
University of Miami
Coral Gables, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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