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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | Capsules containing 1x10^9 colony forming units of Lactobacillus Rhamnosus (JB-1) will be given once per day for 4 weeks. |
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| Placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus Rhamnosus (JB-1) | Dietary Supplement | Lactobacillus Rhamnosus (JB-1) capsule |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ted Dinan, MD, PhD | University College Cork | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| APC Microbiome Institute | Cork | Cork | Ireland |
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| Placebo |
| Dietary Supplement |
Placebo |
|
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 |