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

Not Applicable

Recruiting

• Conditions: Gut Microbiome; Cognition
• Interventions: Device: Transcutaneous Vagal Nerve Stimulation (tVNS); Dietary Supplement: Probiotic Supplement

• Registration Number: NCT05090267
• Lead Sponsor: University of Florida

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-21
• Study First Submitted QC: 2021-10-11
• Study First Posted: 2021-10-22
• Study Start: 2022-06-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-10
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Device (including sham)	Transcutaneous Vagal Nerve Stimulation (tVNS)	Transcutaneous Vagal Nerve Stimulation (tVNS)
Dietary Supplement (e.g., vitamins, minerals)	Probiotic Supplement	Visbiome probiotic supplement

Primary Outcome Measures

Name	Time	Method
Reduction of dysbiosis from day 1 to day 90	Baseline up to 90 days	The gut microbiome will be analyzed through stool samples to measure for changes in biodiversity including an increase in beneficial bacteria.
Improved cognition from day 1 to day 90	Baseline up to 90 days	Various indices of cognition will be measured using standard neuropsychological tests and neuroimaging at multiple time points and examined for change within subjects.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Coral Gables, Florida, United States