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

NCT03160066 | Completed

• 1 other identifier: APC057
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Psychobiotic; Brain-gut axis; Stress; Cognition; EEG

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in the Inflammatory profile

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

• Changes in Mood

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

• Change in Electroencephalography (EEG)

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

• Change in Salivary cortisol concentrations

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

• Changes in Anxiety

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

Study Arms (2)

Active

ACTIVE COMPARATOR

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)

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.

Dietary Supplement: Placebo

Interventions

Lactobacillus Rhamnosus (JB-1) DIETARY_SUPPLEMENT

Lactobacillus Rhamnosus (JB-1) capsule

Active

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• able to give informed written consent
• able to speak English

You may not qualify if:

• 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

Sponsors & Collaborators

• University College Cork: lead

Study Sites (1)

APC Microbiome Institute

Cork, Cork, Ireland

Location

Study Officials

• Ted Dinan, MD, PhD

  University College Cork

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 17, 2015
• First Posted: May 19, 2017
• Study Start: July 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: May 30, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)