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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Lactobacillus Rhamnosus (JB-1)

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Cork, Ireland, Cork
    • APC Microbiome Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active; 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); Lactobacillus Rhamnosus (JB-1) capsule
Placebo Comparator: 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.	Dietary supplement: Placebo; Placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University College Cork
• Investigators: Principal Investigator: Ted Dinan, MD, PhD, University College Cork

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: December 17, 2015
• First Submitted That Met QC Criteria: May 17, 2017
• First Posted (Actual): May 19, 2017

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 24, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Stress; Cognition; EEG; Brain-gut axis; Psychobiotic
• Other Study ID Numbers: APC057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No