Recruiting

Probiotics & TVNS

Sponsor:

University of Florida

Code:

NCT05090267

Conditions

Cognition

Gut Microbiome

Eligibility Criteria

Sex: All

Age: 35 - 70

Healthy Volunteers: Not accepted

Interventions

Probiotic Supplement

Transcutaneous Vagal Nerve Stimulation (tVNS)

Study Details

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

Study ID

NCT05090267

Start date

Jun 1, 2022

Status verified date

Jun, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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

Visbiome probiotic supplement

active comparator: Device (including sham)

Transcutaneous Vagal Nerve Stimulation (tVNS)

Interventions

Probiotic Supplement

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

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.

Primary outcome measure

  • Improved cognition from day 1 to day 90 [ Time Frame: Baseline up to 90 days ]
  • Reduction of dysbiosis from day 1 to day 90 [ Time Frame: Baseline up to 90 days ]

Central Contacts and Locations

Central contacts

Emily Carter

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

Locations

University of Miami

Recruiting

Coral Gables, Florida, United States, 33146

Contacts

Varan Govind, PhD

305-243-8096vgovind@umail.miami.edu

Principal Investigator:

Varan Govind, PhD

More Information

Sponsor

University of Florida

Last update posted

Aug 6, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Florida on 2026-08-06.