NCT05090267View on ClinicalTrials.gov

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

NARecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

June 1, 2022

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
CognitionGut Microbiome
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.

Trial Locations (1)

33146

RECRUITING

University of Miami, Coral Gables

Sponsors
All Listed Sponsors
collaborator

University of Miami

OTHER

collaborator

University of Louisville

OTHER

collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

collaborator

Exegi Pharma, LLC

INDUSTRY

collaborator

Soterix Medical

INDUSTRY

lead

University of Florida

OTHER

NCT05090267 - The Path Study: Cognitive and Inflammation Targeted Gut-brain Interventions in Alcohol; Probiotics, Alcohol, Transcutaneous Vagus Nerve Stimulation, and HIV Study | Biotech Hunter | Biotech Hunter