NCT05090267Recruiting
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
Source: ClinicalTrials.gov · Last updated 6 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 21 Sept 2021
- Start date
- Jun 2022
- Primary completion date
- Dec 2026
- Lead sponsor
- University of Florida
- Diseases
- HIV
- NCT number
- NCT05090267
What you commit to
- Study type: Interventional
- Planned participants: 80
- From Jun 2022 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosed major psychiatric illness
- Lifetime history of medically-assisted alcohol detoxification
- Physical impairment precluding motor response or lying still.
Other
- Consumption of over 300 drinks in the past 30 days
- Recent opioid use
- Inpatient or intensive treatment for addictive behaviors in the past 12 months
- MRI contraindications
- Current antibiotic treatment
- Current probiotic use
Who the study is looking for
- Age 35-70 years
- English or Spanish speaking
- Alcohol users
- Cognitive impairment
- Current CD4\>350
Age in the registry: 35 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Miami Coordinator of this site? Confirm its status | Coral Gables | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.