Probiotics + tVNS for Cognition Improvement
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using antibiotics or probiotics.
What data supports the effectiveness of the treatment Probiotics + tVNS for Cognition Improvement?
Research shows that probiotics can enhance cognitive function and affect brain activity through the gut-brain axis, which involves the vagus nerve. Additionally, probiotics have been found to improve cognitive impairment in both humans and animals, suggesting potential benefits for cognition improvement.12345
Is the combination of probiotics and tVNS generally safe for humans?
Research on probiotics shows they can influence brain function and behavior through the gut-brain axis, and they have been used safely in various studies. However, specific safety data on the combination of probiotics with transcutaneous vagal nerve stimulation (tVNS) is not provided in the available research.23467
How is the Probiotics + tVNS treatment for cognition improvement different from other treatments?
This treatment is unique because it combines probiotics, which can influence brain function through the gut-brain axis, with transcutaneous vagal nerve stimulation (tVNS), a non-invasive method that stimulates the vagus nerve to potentially enhance cognitive function. This dual approach targets both the gut microbiome and neural pathways, offering a novel way to improve cognition compared to traditional treatments.12346
Research Team
Eric Porges, PhD
Principal Investigator
University of Florida
Robert L Cook, MD
Principal Investigator
University of Florida
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the Visbiome probiotic supplement or Transcutaneous Vagal Nerve Stimulation (tVNS) to target the gut-brain axis
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Probiotic Supplement
- Transcutaneous Vagal Nerve Stimulation (tVNS)
Probiotic Supplement is already approved in European Union, United States, Canada, Japan for the following indications:
- Supportive therapy for gastrointestinal health
- Prevention of antibiotic-associated diarrhea
- Dietary supplement for gut health
- Prevention of necrotizing enterocolitis in preterm infants
- Natural health product for digestive health
- Supportive therapy for irritable bowel syndrome
- Food for specified health uses (FOSHU) for gut health
- Prevention of allergic diseases
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor
University of Miami
Collaborator
University of Louisville
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Exegi Pharma, LLC
Industry Sponsor
Soterix Medical
Industry Sponsor
Exegi Pharma, LLC
Collaborator