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

NCT05090267 | Recruiting DMC FDA Device

• 3 other identifiers: CED000000532P01AA029543PRO00035889
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cognition; Gut Microbiome

Outcome Measures

Primary Outcomes (2)

• Improved cognition from day 1 to day 90

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

  Baseline up to 90 days

• Reduction of dysbiosis from day 1 to day 90

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

  Baseline up to 90 days

Study Arms (2)

Dietary Supplement (e.g., vitamins, minerals)

EXPERIMENTAL

Visbiome probiotic supplement

Dietary Supplement: Probiotic Supplement

Device (including sham)

ACTIVE COMPARATOR

Transcutaneous Vagal Nerve Stimulation (tVNS)

Device: Transcutaneous Vagal Nerve Stimulation (tVNS)

Interventions

Probiotic Supplement DIETARY_SUPPLEMENT

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

Dietary Supplement (e.g., vitamins, minerals)

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.

Device (including sham)

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

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

Study Sites (1)

University of Miami

Coral Gables, Florida, 33146, United States

RECRUITING

Study Officials

• Eric Porges, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

• Robert L Cook, MD

  University of Florida

  STUDY DIRECTOR

Central Study Contacts

Emily Carter

CONTACT

352-294-5837; em.carter@phhp.ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a 2x2 design in which subjects will be randomly assigned to one of 4 interventions groups: tVNS and probiotic (n=20); tVNS and placebo (n=20), sham stimulator and probiotic (n=20), and sham stimulator and placebo (n=20). We will use a computer-assisted stratified block randomization with block size of 4 to assign participants to the intervention. Study participants, investigators, staff, and physicians administering the probiotics or placebo will be unaware of specific group assignment. The stratified, blocked randomization and assignment of participants to the 4 intervention groups will be guided and monitored by Data Science Core.
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a 2 x 2 factorial, longitudinal design (tVNS/Sham, Probiotic/Placebo) across three time points (baseline; 30days and 90days).

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: October 22, 2021
• Study Start: June 1, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-06

Locations

US (1)