The Effects of Lactobacillus Rhamnosus (JB-1) on Stress and Cognition

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Lactobacillus Rhamnosus (JB-1) on Stress and Cognition in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Lactobacillus Rhamnosus (JB-1)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active<br>Capsules containing 1x10^9 colony forming units of Lactobacillus Rhamnosus (JB-1) will be given once per day for 4 weeks. | Dietary Supplement: Lactobacillus Rhamnosus (JB-1)<br>* Lactobacillus Rhamnosus (JB-1) capsule<br>|
| Placebo Comparator: Placebo<br>Placebo capsules identical to the probiotic in taste, smell, colour, and comprised only of the same non-active ingredients (corn starch, magnesium stearate and silicon dioxide) in the probiotic supplement will be given once per day for 4 weeks. | Dietary Supplement: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cognition | A battery of cognitive tests will be assessed using the Cambridge Neuropsychological Test Automated Battery | Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Inflammatory profile | Cytokine levels and toll-like receptor activity | Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment | 
| Changes in Mood | Beck Depression Inventory | Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment | 
| Change in Electroencephalography (EEG) | 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 from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment | 
| Change in Salivary cortisol concentrations | Salivary cortisol will be collected before and after the socially evaluated cold pressor procedure. | Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment | 
| Changes in Anxiety | Beck Anxiety Inventory | Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment | 
| Changes in Stress levels | Perceived Stress Scale | Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychobiotic, Brain-gut axis, Stress, Cognition, EEG