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NCT Number: NCT05090267

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

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.

Recruiting

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Key information

Conditions

Cognition Gut Microbiome

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Coral Gables, Florida, 33146, United States

Location status: Recruiting

Location contact

Varan Govind, PhD

CONTACT

[email protected]

305-243-8096

Varan Govind, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic supplement

Dietary Supplement

Participants will take a probiotic supplement or placebo for 90 days.

Transcutaneous Vagal Nerve Stimulation (tVNS)

Device

Participants will use a non-invasive stimulator 1 hour daily for 30 days. This stimulator is placed around the ear similar to headphones and produces a very mile electric current. This wellness device is safe to use and painless. Some describe the sensation to be a slight tingle up to a small itch.

Primary outcomes

  1. Improved cognition from day 1 to day 90

    Time frame: Baseline 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.

  2. Reduction of dysbiosis from day 1 to day 90

    Time frame: Baseline 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Carter

CONTACT

[email protected]

352-294-5837

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Exegi Pharma, LLC
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • Soterix Medical
  • University of Louisville
  • University of Miami

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Oct 22, 2021
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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