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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Cognition, Gut Microbiome

In brief

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.

Key facts

Study ID

NCT05090267

Run by

University of Florida

People needed

80

Starts

2022-06-01

Expected to finish

2026-12-30

Last updated by the study team

2026-08-06

Who can join

Age: 35 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 35-70 years
• English or Spanish speaking
• Alcohol users
• Cognitive impairment
• Current CD4>350

You may not qualify if…

• 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.

Where it is running

• University of Miami — Coral Gables, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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