RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-06-01
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05090267

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:35 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 35-70 years
  2. * English or Spanish speaking
  3. * Alcohol users
  4. * Cognitive impairment
  5. * Current CD4\>350
  1. * Diagnosed major psychiatric illness
  2. * Consumption of over 300 drinks in the past 30 days
  3. * Recent opioid use
  4. * Lifetime history of medically-assisted alcohol detoxification
  5. * Inpatient or intensive treatment for addictive behaviors in the past 12 months
  6. * MRI contraindications
  7. * Current antibiotic treatment
  8. * Current probiotic use
  9. * Physical impairment precluding motor response or lying still.

Contacts and Locations

Study Contact

Emily Carter
CONTACT
352-294-5837
em.carter@phhp.ufl.edu

Principal Investigator

Eric Porges, PhD
PRINCIPAL_INVESTIGATOR
University of Florida
Robert L Cook, MD
STUDY_DIRECTOR
University of Florida

Study Locations (Sites)

University of Miami
Coral Gables, Florida, 33146
United States

Collaborators and Investigators

Sponsor: University of Florida

  • Eric Porges, PhD, PRINCIPAL_INVESTIGATOR, University of Florida
  • Robert L Cook, MD, STUDY_DIRECTOR, University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-01
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2022-06-01
Study Completion Date2026-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Cognition
  • Gut Microbiome