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The Path Study: Probiotics and tVNS for Cognition and Gut Health in Alcohol Users with HIV

This study, called The Path Study, is looking at two ways to improve thinking skills (cognition) and gut health in people aged 35-70 who use alcohol and have HIV. You might receive a probiotic supplement or a placebo (inactive substance) for 90 days. You might also use a Transcutaneous Vagal Nerve Stimulator (tVNS), a small device placed near your ear that sends a gentle electrical current, for one hour daily over 30 days. The study aims to see if these interventions can improve your thinking abilities and balance the bacteria in your gut. To join, you must be an English or Spanish speaker, use alcohol, and have some cognitive impairment and a current CD4 count above 350. The study is currently unclear about its recruitment status.

Study design
This interventional study plans to enroll 80 participants. It is evaluating two interventions: a probiotic supplement and a tVNS device.
What's involved
Participants will take a probiotic supplement or placebo for 90 days. They will also use a tVNS device for 1 hour daily for 30 days.
Compensation
Not stated in the trial record.
Follow-up
Cognition and gut bacteria balance will be measured from the start of the study up to 90 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05090267

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

Recruiting
NAAges 35–70InterventionalBasic science
University of Florida
~80 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:Probiotic SupplementTranscutaneous Vagal Nerve Stimulation (tVNS)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Improved cognition from day 1 to day 90
Measured over Baseline up to 90 days
+1 more outcome measured

Conditions

Cognition
Gut Microbiome

Explore related trials

HIV InfectionCD4 Gene

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Eric Porges, PhD · PRINCIPAL_INVESTIGATOR · University of Florida
  • Robert L Cook, MD · STUDY_DIRECTOR · University of Florida

Who to contact

Emily Carter
[email protected]
352-294-5837
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

  • Improved cognition from day 1 to day 90Baseline up to 90 days

    Various indices of cognition will be measured using standard neuropsychological tests and neuroimaging at multiple time points and examined for change within subjects.

  • Reduction of dysbiosis from day 1 to day 90Baseline up to 90 days

    The gut microbiome will be analyzed through stool samples to measure for changes in biodiversity including an increase in beneficial bacteria.