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

University of Florida

Status: Enrolling

Conditions: Gut Microbiome; Cognition

Treatments: Dietary Supplement: Probiotic Supplement; Device: Transcutaneous Vagal Nerve Stimulation (tVNS)

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT05090267

CED000000532

PRO00035889 (Other Identifier)

P01AA029543 (U.S. NIH Grant/Contract)

Details and patient eligibility

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

---

80 participants in 2 patient groups

Dietary Supplement (e.g., vitamins, minerals)

Experimental group

Description:

Visbiome probiotic supplement

Treatment:

Dietary Supplement: Probiotic Supplement

Device (including sham)

Active Comparator group

Description:

Transcutaneous Vagal Nerve Stimulation (tVNS)

Treatment:

Device: Transcutaneous Vagal Nerve Stimulation (tVNS)