The Effects of Lactobacillus Rhamnosus (JB-1) on Stress and Cognition in Healthy Volunteers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- University College Cork
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Change in Cognition
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Prof Ted Dinan
Professor
University College Cork
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in Cognition
Time Frame: 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 Outcomes
- Change in the Inflammatory profile(Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment)
- Change in Salivary cortisol concentrations(Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment)
- Changes in Mood(Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment)
- Changes in Anxiety(Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment)
- Change in Electroencephalography (EEG)(Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment)
- Changes in Stress levels(Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment)