Healthy
Conditions
Keywords
Psychobiotic, Brain-gut axis, Stress, Cognition, EEG
Brief summary
Emerging evidence suggests that microorganisms acting via the Brain-Gut axis may have potential benefits for the management of stress-related conditions. The majority of studies have focused on animal models. Preclinical studies have identified the Lactobacillus Rhamnosus JB-1 strain as a putative psychobiotic with an impact on stress-related behaviours, physiology and cognitive performance. Whether such preclinical effects could be translated to healthy human volunteers remains unknown.
Detailed description
30 healthy male volunteers will be recruited in a randomized single blind placebo controlled cross over trial. Study participation will involve a screening visit followed by a baseline cognitive test battery, EEG and stress visit (socially evaluated cold-pressor test). These measures will be repeated after 4 weeks of daily probiotic and placebo capsules.
Interventions
DIETARY_SUPPLEMENTLactobacillus Rhamnosus (JB-1)
Lactobacillus Rhamnosus (JB-1) capsule
DIETARY_SUPPLEMENTPlacebo
Placebo
Sponsors
University College Cork
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* able to give informed written consent * able to speak English
Exclusion criteria
* having a significant acute or chronic illness * following a diet or taking a medication that would interfere with study objectives * pose a safety risk or confound the interpretation of the study results * evidence of immunodeficiency, bleeding disorder or coagulopathy * English not being participant's first language * colour blindness * dyslexia or dyscalculia * taking any probiotic products or antibiotics in the last 4 weeks * receiving any treatment involving experimental drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cognition | Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment | A battery of cognitive tests will be assessed using the Cambridge Neuropsychological Test Automated Battery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Mood | Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment | Beck Depression Inventory |
| Change in Electroencephalography (EEG) | Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment | EEG measures of absolute power in the delta (1.5-3.5Hz), theta (4-7.5Hz), alpha1 (8- 9.5Hz), alpha2 (10-12.5Hz), beta1 (13-17.5Hz), and beta2 (18-25.5Hz) frequency bands |
| Change in the Inflammatory profile | Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment | Cytokine levels and toll-like receptor activity |
| Changes in Anxiety | Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment | Beck Anxiety Inventory |
| Changes in Stress levels | Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment | Perceived Stress Scale |
| Change in Salivary cortisol concentrations | Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment | Salivary cortisol will be collected before and after the socially evaluated cold pressor procedure. |
Countries
Ireland
Outcome results
None listed