[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100446194":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":38,"locations":44,"responsibleParty":65,"collaborators":67,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":26,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":26,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":26,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"University of Florida","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dietary Supplement (e.g., vitamins, minerals)","EXPERIMENTAL","Visbiome probiotic supplement",[13],"Dietary Supplement: Probiotic Supplement",{"label":15,"type":16,"description":17,"interventionNames":18},"Device (including sham)","ACTIVE_COMPARATOR","Transcutaneous Vagal Nerve Stimulation (tVNS)",[19],"Device: Transcutaneous Vagal Nerve Stimulation (tVNS)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Probiotic Supplement","Participants will take a probiotic supplement or placebo for 90 days.",[9],null,{"type":28,"name":17,"description":29,"armGroupLabels":30,"otherNames":26},"DEVICE","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.",[15],[32,35],{"name":33,"affiliation":5,"role":34},"Eric Porges, PhD","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":5,"role":37},"Robert L Cook, MD","STUDY_DIRECTOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":26,"email":43},"Emily Carter","CONTACT","352-294-5837","em.carter@phhp.ufl.edu",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"University of Miami","RECRUITING","Coral Gables","Florida","33146","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-80.26838,25.72149,{"lat":57,"lon":56},[60,64],{"name":61,"role":41,"phone":62,"phoneExt":26,"email":63},"Varan Govind, PhD","305-243-8096","vgovind@umail.miami.edu",{"name":61,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":66,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[68,69,71,74,77],{"name":46,"class":6},{"name":70,"class":6},"University of Louisville",{"name":72,"class":73},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","NIH",{"name":75,"class":76},"Exegi Pharma, LLC","INDUSTRY",{"name":78,"class":76},"Soterix Medical","100446194","the-path-study-cognitive-and-inflammation-targeted-gut-brain-interventions-in-alcohol-probiotics-alcohol-transcutaneous-vagus-nerve-stimulation-and-hiv-study-100446194",false,"NCT05090267","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","Inclusion Criteria:\n\n* Age 35-70 years\n* English or Spanish speaking\n* Alcohol users\n* Cognitive impairment\n* Current CD4\\>350\n\nExclusion Criteria:\n\n* Diagnosed major psychiatric illness\n* Consumption of over 300 drinks in the past 30 days\n* Recent opioid use\n* Lifetime history of medically-assisted alcohol detoxification\n* Inpatient or intensive treatment for addictive behaviors in the past 12 months\n* MRI contraindications\n* Current antibiotic treatment\n* Current probiotic use\n* Physical impairment precluding motor response or lying still.","ALL","35 Years","70 Years",{"count":90,"type":91},80,"ESTIMATED","INTERVENTIONAL",[94],"NA","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.",[97,98],"Cognition","Gut Microbiome","2026-08-04",{"date":101,"type":102},"2026-08-06","ACTUAL",{"date":104,"type":102},"2022-06-01",{"date":106,"type":91},"2026-12-30",{"name":5,"class":6},1]