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 type | Interventional |
|---|---|
| Ages | 35 Years to 70 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Coral Gables, Florida) |
| Status | Recruiting |
| Started | June 1, 2022 |
| Main results expected | December 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | August 6, 2026 |
| Trial ID | NCT05090267 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
- Principal investigator: Eric Porges, PhD — University of Florida
- Study coordinator: Emily Carter
- Email: em.carter@phhp.ufl.edu
- Phone: 352-294-5837
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.