80 Participants Needed

Probiotics + tVNS for Cognition Improvement

TL
EC
Overseen ByEmily Carter
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

EP

Eric Porges, PhD

Principal Investigator

University of Florida

RL

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

I speak English or Spanish.
I have difficulty with memory or thinking clearly.
I am between 35 and 70 years old.
See 2 more

Exclusion Criteria

Current probiotic use
Diagnosed major psychiatric illness
I have not been in intensive treatment for addiction in the last year.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Visbiome probiotic supplement or Transcutaneous Vagal Nerve Stimulation (tVNS) to target the gut-brain axis

12 weeks
Multiple visits for neuropsychological tests and stool sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Probiotic Supplement
  • Transcutaneous Vagal Nerve Stimulation (tVNS)
Trial OverviewThe 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.
Participant Groups
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)

Probiotic Supplement is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Probiotics for:
  • Supportive therapy for gastrointestinal health
  • Prevention of antibiotic-associated diarrhea
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Approved in United States as Probiotics for:
  • Dietary supplement for gut health
  • Prevention of necrotizing enterocolitis in preterm infants
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Approved in Canada as Probiotics for:
  • Natural health product for digestive health
  • Supportive therapy for irritable bowel syndrome
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Approved in Japan as Probiotics for:
  • 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

Trials
1,428
Recruited
987,000+

University of Miami

Collaborator

Trials
976
Recruited
423,000+

University of Louisville

Collaborator

Trials
353
Recruited
76,400+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials
865
Recruited
1,091,000+

Exegi Pharma, LLC

Industry Sponsor

Trials
3
Recruited
220+

Soterix Medical

Industry Sponsor

Trials
12
Recruited
410+

Exegi Pharma, LLC

Collaborator

Trials
2
Recruited
170+

Findings from Research

A meta-analysis of 7 human trials and 11 animal studies found that probiotics significantly enhance cognitive function, with a moderate effect size of 0.24 in humans and a strong effect size of 0.90 in animals.
Probiotics were particularly effective in cognitively impaired individuals compared to healthy individuals, suggesting that tailored probiotic interventions may be beneficial for those with cognitive disorders.
Probiotics treatment improves cognitive impairment in patients and animals: A systematic review and meta-analysis.Lv, T., Ye, M., Luo, F., et al.[2021]
Ingestion of the probiotic Lactobacillus rhamnosus (JB-1) significantly increased neuronal activity in the mesenteric nerve bundle of mice, indicating that it influences gut-brain signaling through vagal afferents.
The effects of JB-1 on neuronal firing were completely blocked by prior vagotomy, suggesting that the gut-brain communication facilitated by this probiotic is dependent on the vagus nerve, highlighting its potential role in psychiatric treatments.
Psychoactive bacteria Lactobacillus rhamnosus (JB-1) elicits rapid frequency facilitation in vagal afferents.Perez-Burgos, A., Wang, B., Mao, YK., et al.[2022]
A 3-week intake of probiotics significantly improved body composition in normal weight obese (NWO) and preobese-obese (PreOB/OB) women, leading to reductions in BMI and fat mass, and increases in fat-free mass.
Probiotic treatment also resulted in lower psychological distress and improved gut health, as indicated by reduced symptoms of bacterial overgrowth and better orocecal transit time, suggesting a beneficial effect on both physical and mental health.
Can psychobiotics intake modulate psychological profile and body composition of women affected by normal weight obese syndrome and obesity? A double blind randomized clinical trial.De Lorenzo, A., Costacurta, M., Merra, G., et al.[2018]

References

Probiotics treatment improves cognitive impairment in patients and animals: A systematic review and meta-analysis. [2021]
Psychoactive bacteria Lactobacillus rhamnosus (JB-1) elicits rapid frequency facilitation in vagal afferents. [2022]
Can psychobiotics intake modulate psychological profile and body composition of women affected by normal weight obese syndrome and obesity? A double blind randomized clinical trial. [2018]
Probiotic Mixture Containing Lactobacillus helveticus, Bifidobacterium longum and Lactiplantibacillus plantarum Affects Brain Responses Toward an Emotional Task in Healthy Subjects: A Randomized Clinical Trial. [2022]
Probiotic Mixture Containing Lactobacillus helveticus, Bifidobacterium longum and Lactiplantibacillus plantarum Affects Brain Responses to an Arithmetic Stress Task in Healthy Subjects: A Randomised Clinical Trial and Proof-of-Concept Study. [2022]
Homeostatic regulation of neuronal excitability by probiotics in male germ-free mice. [2022]
Probiotics protect against gut dysbiosis associated decline in learning and memory. [2020]