The Path Study: Cognitive and Inflammation Targeted Gut-brain Interventions in Alcohol; Probiotics, Alcohol, Transcutaneous Vagus Nerve Stimulation, and HIV Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Probiotic Supplement, Transcutaneous Vagal Nerve Stimulation (tVNS).
- Who it may be relevant to
- Registry conditions: Cognition, Gut Microbiome. Basic parameters: 35 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cognitive and Inflammation Targeted Gut-brain Interventions in Alcohol; Probiotics, Alcohol, Transcutaneous Vagus Nerve Stimulation, and HIV Study
Overview
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.
Interventions
- Dietary supplement Probiotic Supplement
Participants will take a probiotic supplement or placebo for 90 days. - Device 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 measures
- 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]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Miami — Coral Gables
Identifiers
NCT: NCT05090267 · CED000000532 · P01AA029543 · PRO00035889