RecruitingNot ApplicableNCT05090267

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

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


Sponsor

University of Florida

Enrollment

80 participants

Start Date

Jun 1, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 35 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether probiotics and a mild brain stimulation technique (transcutaneous vagus nerve stimulation, or tVNS) can improve memory and thinking problems in people living with HIV who also drink alcohol. Researchers believe that treating gut health and inflammation may help brain function. **You may be eligible if...** - You are between 35 and 70 years old - You speak English or Spanish - You drink alcohol and have some degree of cognitive (thinking or memory) impairment - You are living with HIV and your CD4 count is above 350 **You may NOT be eligible if...** - You have been diagnosed with a major psychiatric illness - You drank more than 300 drinks in the past 30 days - You have recently used opioids - You have ever needed medically supervised alcohol detoxification - You have received intensive addiction treatment in the past year - You cannot have an MRI scan - You are currently taking antibiotics or probiotics - You have a physical condition that prevents you from lying still or responding motorically Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTProbiotic Supplement

Participants will take a probiotic supplement or placebo for 90 days.

DEVICETranscutaneous 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.


Locations(1)

University of Miami

Coral Gables, Florida, United States

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NCT05090267


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