CognitionNCT05090267
The Path Study: Cognitive and Inflammation Targeted Gut-brain Interventions in Alcohol; Probiotics, Alcohol, Transcutaneous Vagus Nerve Stimulation, and HIV Study
A study testing Probiotic Supplement and Transcutaneous Vagal Nerve Stimulation (tVNS) in people with Cognition and Gut Microbiome, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Cognition, Gut Microbiome
- What is being tested?
- Probiotic Supplement and Transcutaneous Vagal Nerve Stimulation (tVNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 35-70 years
- English or Spanish speaking
- Alcohol users
- Cognitive impairment
- Current CD4>350
Who cannot join
- 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
Show all 9Show fewer
- Current antibiotic treatment
- Current probiotic use
- Physical impairment precluding motor response or lying still.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Coral Gables, Florida, 33146
Varan Govind, PhD, 305-243-8096, vgovind@umail.miami.edu
Varan Govind, PhD
About this study
Official title: 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 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.
- Conditions
- Cognition, Gut Microbiome
- Being tested
- Probiotic Supplement, Transcutaneous Vagal Nerve Stimulation (tVNS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic SupplementDietary supplement
Participants will take a probiotic supplement or placebo for 90 days.
Transcutaneous Vagal Nerve Stimulation (tVNS)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.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplement (e.g., vitamins, minerals) | Experimental | Visbiome probiotic supplement Receives: Dietary Supplement: Probiotic Supplement |
| Device (including sham) | Active comparator | Transcutaneous Vagal Nerve Stimulation (tVNS) Receives: Device: Transcutaneous Vagal Nerve Stimulation (tVNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to 90 days
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.
Measured: Baseline up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start1 Jun 2022
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This is a 2 x 2 factorial, longitudinal design (tVNS/Sham, Probiotic/Placebo) across three time points (baseline; 30days and 90days).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami, University of Louisville, National Institute on Alcohol Abuse and Alcoholism (NIAAA), Exegi Pharma, LLC, Soterix Medical
- Responsible party
- Sponsor
- Investigators
- Eric Porges, PhD, Principal investigator, University of FloridaRobert L Cook, MD, Study director, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090267
- Sponsor's protocol ID
- CED000000532
- Other IDs
- P01AA029543, PRO00035889
- Status last verified
- Jun 2026
- First submitted
- 21 Sep 2021
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Inflammation Targeted Gut-brain Interventions in Alcohol; Probiotics, Alcohol, Transcutaneous Vagus Nerve Stimulation, and HIV Study
- ClinicalTrials.gov ID
- NCT05090267
- Acronym / sponsor ID
- CED000000532
- Conditions
- Cognition, Gut Microbiome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- University of Miami, University of Louisville, National Institute on Alcohol Abuse and Alcoholism (NIAAA), Exegi Pharma, LLC, Soterix Medical
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a 2 x 2 factorial, longitudinal design (tVNS/Sham, Probiotic/Placebo) across three time points (baseline; 30days and 90days).
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement (e.g., vitamins, minerals) | Experimental | Dietary Supplement: Probiotic SupplementVisbiome probiotic supplement |
| Device (including sham) | Active comparator | Device: Transcutaneous Vagal Nerve Stimulation (tVNS)Transcutaneous Vagal Nerve Stimulation (tVNS) |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 35-70 years
- English or Spanish speaking
- Alcohol users
- Cognitive impairment
- Current CD4>350
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic SupplementParticipants will take a probiotic supplement or placebo for 90 days. | Dietary supplement | Dietary Supplement (e.g., vitamins, minerals) |
| 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. | Device | Device (including sham) |
Primary outcome
Improved cognition from day 1 to day 90
Time frame: Baseline up to 90 days
Various indices of cognition will be measured using standard neuropsychological tests and neuroimaging at multiple time points and examined for change within subjects.
Reduction of dysbiosis from day 1 to day 90
Time frame: Baseline up to 90 days
The gut microbiome will be analyzed through stool samples to measure for changes in biodiversity including an increase in beneficial bacteria.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric Porges, PhD principal investigator
University of Florida
Robert L Cook, MD study director
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Supplement and Transcutaneous Vagal Nerve Stimulation (tVNS) in people with Cognition and Gut Microbiome, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Carter (352-294-5837, em.carter@phhp.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved cognition from day 1 to day 90 (time frame: Baseline up to 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.