Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03160066
Recruitment Status : Completed
First Posted : May 19, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Prof Ted Dinan, University College Cork

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Lactobacillus Rhamnosus (JB-1) Dietary Supplement: Placebo Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effects of Lactobacillus Rhamnosus (JB-1) on Stress and Cognition in Healthy Volunteers
Study Start Date : July 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03160066


Locations
Layout table for location information
Ireland
APC Microbiome Institute
Cork, Ireland, Cork
Sponsors and Collaborators
University College Cork
Investigators
Layout table for investigator information
Principal Investigator: Ted Dinan, MD, PhD University College Cork

Layout table for additonal information
Responsible Party: Prof Ted Dinan, Professor, University College Cork
ClinicalTrials.gov Identifier: NCT03160066     History of Changes
Other Study ID Numbers: APC057
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof Ted Dinan, University College Cork:
Psychobiotic
Brain-gut axis
Stress
Cognition
EEG