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

Study Overview

• Status: Recruiting
• Conditions: Cognition; Gut Microbiome
• Intervention / Treatment: Dietary supplement: Probiotic Supplement; Device: Transcutaneous Vagal Nerve Stimulation (tVNS)

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emily Carter; Phone Number: 352-294-5837; Email: em.carter@phhp.ufl.edu

Study Locations

• United States
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Recruiting
      • University of Miami
      • Contact: Varan Govind, PhD; Phone Number: 305-243-8096; Email: vgovind@umail.miami.edu
      • Principal Investigator: Varan Govind, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 31 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dietary Supplement (e.g., vitamins, minerals); Visbiome probiotic supplement	Dietary supplement: Probiotic Supplement; Participants will take a probiotic supplement or placebo for 90 days.
Active Comparator: Device (including sham); Transcutaneous Vagal Nerve Stimulation (tVNS)	Device: Transcutaneous Vagal Nerve Stimulation (tVNS); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); University of Miami; University of Louisville; Soterix Medical; Exegi Pharma, LLC
• Investigators: Study Director: Robert L Cook, MD, University of Florida; Principal Investigator: Eric Porges, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: September 21, 2021
• First Submitted That Met QC Criteria: October 11, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: June 12, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: CED000000532; P01AA029543 (U.S. NIH Grant/Contract); PRO00035889 (Other Identifier: UFirst)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes