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Completed

NCT Number: NCT03160066

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

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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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

APC Microbiome Institute

Cork, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactobacillus Rhamnosus (JB-1)

Dietary Supplement

Lactobacillus Rhamnosus (JB-1) capsule

Placebo

Dietary Supplement

Placebo

Primary outcomes

  1. 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

  1. Change in the Inflammatory profile

    Time frame: Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment

    Cytokine levels and toll-like receptor activity

  2. Changes in Mood

    Time frame: Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment

    Beck Depression Inventory

  3. Change in Electroencephalography (EEG)

    Time frame: Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment

    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

  4. Change in Salivary cortisol concentrations

    Time frame: Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment

    Salivary cortisol will be collected before and after the socially evaluated cold pressor procedure.

  5. Changes in Anxiety

    Time frame: Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment

    Beck Anxiety Inventory

  6. Changes in Stress levels

    Time frame: Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment

    Perceived Stress Scale

Sponsors and collaborators

Lead sponsor

University College Cork

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 19, 2017
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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