Clinical trial Recruiting at 1 site Interventional Ages 35 to 70

Cognitive and gut health interventions for alcohol users with HIV

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

Run by University of Florida · NCT05090267 · Data updated 2026-11-12

This study tests two different approaches to help people with HIV who drink alcohol by using a device to stimulate the nervous system and a probiotic to improve gut health and brain function.

Quick facts

Study typeInterventional
Ages35 Years to 70 Years
SexAll
Enrollment80 (estimated)
SponsorUniversity of Florida
Academic / other
Locations1 site (Coral Gables, Florida)
StatusRecruiting
StartedJune 1, 2022
Main results expectedDecember 30, 2026
Study endsDecember 30, 2026
Registry record updatedAugust 6, 2026
Trial IDNCT05090267 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are English or Spanish speaking adults aged 35-70 with cognitive impairment and a history of alcohol use.

Probably not a fit

Patients with major psychiatric illnesses or those who have recently undergone intensive treatment for addictive behaviors may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project evaluates two interventions aimed at improving cognition and gut health in individuals with HIV who consume alcohol. One intervention involves using a portable Transcutaneous Vagus Nerve Stimulator (tVNS) to stimulate the autonomic nervous system, potentially reducing inflammation and enhancing cognitive function. The second intervention is a probiotic supplement designed to restore healthy gut bacteria in participants experiencing dysbiosis. The study employs a hybrid trial design to assess the effectiveness of these interventions.

Why it matters

Potential benefit: If successful, this study could lead to improved cognitive function and gut health for individuals with HIV who consume alcohol.

How similar studies have gone: While the specific combination of interventions is novel, similar approaches targeting the gut-brain axis have shown promise in other studies.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • University of Miami
    Coral Gables, Florida, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.