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Probiotic Supplement

Probiotics + tVNS for Cognition Improvement

N/A

Recruiting

Led By Eric Porges, PhD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cognitive impairment

Age 35-70 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 90 days

Awards & highlights

Study Summary

This trial is testing two interventions to see if they can improve cognition by targeting the gut-brain axis. One is a portable device to stimulate the autonomic nervous system, and the other is a probiotic supplement.

Who is the study for?

This trial is for English or Spanish speakers aged 35-70 who consume alcohol, have a CD4 count over 350, and some cognitive impairment. It's not for those with recent opioid use, past-year intensive addiction treatment, current antibiotic or probiotic use, major psychiatric illness, or very high alcohol consumption.Check my eligibility

What is being tested?

The study tests two interventions: a portable Transcutaneous Vagus Nerve Stimulator (tVNS) thought to reduce inflammation and boost cognition; and a probiotic supplement aimed at improving gut health in people with HIV affected by alcohol.See study design

What are the potential side effects?

Potential side effects may include discomfort from the tVNS device and changes in digestion due to the probiotics. Individual reactions can vary based on personal health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have difficulty with memory or thinking clearly.

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I am between 35 and 70 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Improved cognition from day 1 to day 90

Reduction of dysbiosis from day 1 to day 90

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Dietary Supplement (e.g., vitamins, minerals)Experimental Treatment1 Intervention

Visbiome probiotic supplement

Group II: Device (including sham)Active Control1 Intervention

Transcutaneous Vagal Nerve Stimulation (tVNS)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Probiotic Supplement

2006

N/A

~180

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,341 Previous Clinical Trials

715,587 Total Patients Enrolled

1 Trials studying Cognition

48 Patients Enrolled for Cognition

University of MiamiOTHER

902 Previous Clinical Trials

409,996 Total Patients Enrolled

University of LouisvilleOTHER

339 Previous Clinical Trials

76,600 Total Patients Enrolled

Media Library

Probiotic Supplement (Probiotic Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05090267 — N/A

Cognition Research Study Groups: Dietary Supplement (e.g., vitamins, minerals), Device (including sham)

Cognition Clinical Trial 2023: Probiotic Supplement Highlights & Side Effects. Trial Name: NCT05090267 — N/A

Probiotic Supplement (Probiotic Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05090267 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a minimum age requirement for participation in this experiment?

"In order to be deemed eligible for this experiment, patients must have an age between 35 and 70 years old."

Answered by AI

Is the opportunity to enroll in this research currently available?

"According to the details available on clinicaltrials.gov, this medical trial is currently seeking participants; it was initially posted in June 1st 2022 and its latest update occured 5 days ago at July 5th of the same year."

Answered by AI

What is the current cap on participants for this medical trial?

"Affirmative. Clinicaltrials.gov attests to this trial's recruitment status, which began on June 1st of 2022 and most recently updated in the 5th day of July 2022. 80 participants are needed for a single test site."

Answered by AI

What criteria must one meet to be a participant in this clinical trial?

"To participate in this medical study, potential patients must present with cognitive acuity and fall within the ages of 35 to 70. The team behind the trial are looking for 80 individuals that meet these criteria."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "The Path Study: Cognitive and Inflammation Targeted Gut-brain Interventions in Alcohol; Probiotics, Alcohol, Transcutaneous Vagus Nerve Stimulation, and HIV Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05090267.