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

Cognition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05090267
• Other study ID #: CED000000532
• Secondary ID: P01AA029543PRO00
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: May 2024
• Source: University of Florida
• Contact: Emily Carter
• Phone: 352-294-5837
• Email: em.carter[@]phhp.ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognition
• Gut Microbiome
• Inflammation

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami	Coral Gables	Florida

Sponsors (6)

Lead Sponsor	Collaborator
University of Florida	Exegi Pharma, LLC, National Institute on Alcohol Abuse and Alcoholism (NIAAA), Soterix Medical, University of Louisville, University of Miami

Country where clinical trial is conducted

United States, 

Outcome

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