The Path Study: Cognitive and Inflammation Targeted Gut-brain Interventions in Alcohol; Probiotics, Alcohol, Transcutaneous Vagus Nerve Stimulation, and HIV Study
Recruiting · NCT05090267 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Florida
View the official record on ClinicalTrials.gov →Interventions studied
Probiotic SupplementTranscutaneous Vagal Nerve Stimulation (tVNS)
What this trial is about
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.
Who can take part
Age range
35 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed across 1 US state.
- University of Miami - Coral Gables, Florida, United States