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NCT05090267 · ClinicalTrials.gov registry record · NA

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

A NA study of Cognition and Gut Microbiome, sponsored by University of Florida.

Recruiting
Registry status
NA
Development phase
80
Enrollment target
1
Study location

NCT05090267: Recruiting NA study of Cognition and Gut Microbiome, sponsored by University of Florida.

NCT05090267 is a NA study of Cognition and Gut Microbiome that is actively recruiting participants, run by University of Florida. The registered enrollment target is 80 participants, below the 169-participant average among 35 other Cognition trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05090267, a NA study of Cognition and Gut Microbiome, is actively recruiting participants, sponsored by University of Florida.

RECRUITING
Registry status
NA
Development phase
80 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

Various indices of cognition will be measured using standard neuropsychological tests and neuroimaging at multiple time points and examined for change within subjects.

Conditions Studied

Interventions

  • DIETARY_SUPPLEMENT Probiotic Supplement
  • DEVICE Transcutaneous Vagal Nerve Stimulation (tVNS)

Study Locations (1)

Florida

  • University of Miami - Coral Gables

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2022-06-01
Est. Completion 2026-06-30
Phase NA
University of Florida

1,106 total trials

What NCT05090267 shows while recruiting

NCT05090267 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 169-participant average among 35 other Cognition trials with a reported enrollment target (53% lower).

The record links to 2 conditions, with Cognition appearing as the primary indexed condition, and to 2 interventions - of which Probiotic Supplement is the first listed.

NCT05090267 reports a single indexed study location in Florida.

Frequently Asked Questions

What is clinical trial NCT05090267 about?

NCT05090267 is a clinical study titled "The Path Study: Cognitive and Inflammation Targeted Gut-brain Interventions in Alcohol; Probiotics, Alcohol, Transcutaneous Vagus Nerve Stimulation, and HIV Study". 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 co...

What is the current status of trial NCT05090267?

This trial is currently recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2022-06-01. Estimated completion is 2026-06-30.

What conditions does trial NCT05090267 study?

This clinical trial studies the following conditions: Cognition, Gut Microbiome.

What interventions are being tested in trial NCT05090267?

The interventions under investigation include: Probiotic Supplement (DIETARY_SUPPLEMENT), Transcutaneous Vagal Nerve Stimulation (tVNS) (DEVICE).

Who is sponsoring clinical trial NCT05090267?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05090267 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Cognition

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05090267's enrollment target sits among peer trials

80 17th of 35 higher than 17 of 35 other Cognition trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cognition trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05090267, the US trial registry maintained by the National Library of Medicine. NCT05090267 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.