Clinical trial NCT03160066: The Effects of Lactobacillus Rhamnosus (JB-1) on Stress and Cognition
Official title: The Effects of Lactobacillus Rhamnosus (JB-1) on Stress and Cognition in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Psychobiotic
Brain-gut axis
Stress
Cognition
EEG
Lead sponsor: University College Cork
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 29
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Cognition
timeFrame: Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment
Secondary outcomes:
measure: Change in the Inflammatory profile
timeFrame: Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment
measure: Changes in Mood
timeFrame: Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment
measure: Change in Electroencephalography (EEG)
timeFrame: Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment
measure: Change in Salivary cortisol concentrations
timeFrame: Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment
measure: Changes in Anxiety
timeFrame: Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment
measure: Changes in Stress levels
timeFrame: Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: APC Microbiome Institute
Study officials:
affiliation: University College Cork
name: Ted Dinan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: