NCT05090267 The Path Study: Cognitive and Inflammation Targeted Gut-brain Interventions in Alcohol; Probiotics, Alcohol, Transcutaneous Vagus Nerve Stimulation, and HIV Study
| NCT ID | NCT05090267 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Florida |
| Condition | Cognition |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2022-06-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2022-06-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Eric Porges, PhD
PRINCIPAL INVESTIGATOR
University of Florida
Frequently Asked Questions
Who can join the NCT05090267 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, up to 70 Years, studying Cognition. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05090267 currently recruiting?
Yes, NCT05090267 is actively recruiting participants. Contact the research team at em.carter@phhp.ufl.edu for enrollment information.
Where is the NCT05090267 trial being conducted?
This trial is being conducted at Coral Gables, United States.
Who is sponsoring the NCT05090267 clinical trial?
NCT05090267 is sponsored by University of Florida. The principal investigator is Eric Porges, PhD at University of Florida. The trial plans to enroll 80 participants.