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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03160066
• Other study ID #: APC057
• Status: Completed
• Phase: N/A
• First received: December 17, 2015
• Last updated: May 24, 2017
• Start date: July 2015
• Est. completion date: September 2016

Study information

• Verified date: May 2017
• Source: University College Cork
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Lactobacillus Rhamnosus (JB-1)
Lactobacillus Rhamnosus (JB-1) capsule
• Placebo
Placebo

Locations

Country	Name	City	State
Ireland	APC Microbiome Institute	Cork

Sponsors (1)

Lead Sponsor	Collaborator
University College Cork

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Changes in Mood	Beck Depression Inventory	Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment
Secondary	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
Secondary	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
Secondary	Changes in Anxiety	Beck Anxiety Inventory	Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment
Secondary	Changes in Stress levels	Perceived Stress Scale	Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment