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

University College Cork (UCC)

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Lactobacillus Rhamnosus (JB-1)

Study type: Interventional

Funder types: Other

Identifiers

NCT03160066

APC057

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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29 participants in 2 patient groups, including a placebo group

Active

Active Comparator group

Description:

Capsules containing 1x10\^9 colony forming units of Lactobacillus Rhamnosus (JB-1) will be given once per day for 4 weeks.

Treatment:

Dietary Supplement: Lactobacillus Rhamnosus (JB-1)

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo