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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-09-30

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.

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Active

Capsules containing 1x10\^9 colony forming units of Lactobacillus Rhamnosus (JB-1) will be given once per day for 4 weeks.

Group Type ACTIVE_COMPARATOR

Lactobacillus Rhamnosus (JB-1)

Intervention Type DIETARY_SUPPLEMENT

Lactobacillus Rhamnosus (JB-1) capsule

Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Interventions

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Lactobacillus Rhamnosus (JB-1)

Lactobacillus Rhamnosus (JB-1) capsule

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes