Clinical trial NCT03427515: Probiotics and Examination-related Stress in Healthy Medical Students
Official title: Effect of Supplementation With Saccharomyces Boulardii and Lactobacillus Rhamnosus on Examination-related Stress in Healthy Medical Students: a Randomised, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Stress-related Problem
Anxiety
Keywords: Psychobiotics
Probiotics
Examination
Stress
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Healthy medical students were assigned
Primary purpose: PREVENTION

Brief summary: Probiotics are live microorganisms exhibiting multiple properties beneficial to health. An increasing body of evidence indicates that probiotics may support healthy brain function and may relieve stress. Recent research in this area has examined lactic acid bacteria in detail, but little is known about the stress-relieving effects of Saccharomyces, a yeast with probiotic properties.

Psychological stress is a factor that allows people to successfully cope with various daily life situations. On the other hand, excessive stress may lead to bodily harm and decrease performance, e.g. academic achievements. Probiotics may help manage stress, but little is known whether probiotics improve performance under stress.

The aim of this trial is to examine whether the healthy medical students may demonstrate better performance in academic examinations when supplementing their diet with a yeast probiotic strain Saccharomyces boulardii (CNCM I-1079) or bacterial probiotic strain Lactobacillus rhamnosus GG (ATCC 53103). The secondary aim of the trial is to evaluate the potential effects of this supplementation on state anxiety as well as on biochemical and physiological stress markers.


Eligibility criteria: Inclusion Criteria:

* Being a third year medical student of the Faculty of Medicine or Faculty of Military Medicine, Medical University of Lodz

Exclusion Criteria:

* formal inability to sit the first attempt of the final examination of Basic Medical Pharmacology
* chronic diseases: neurological, psychiatric, cardiological, gastroenterological, immunological, endocrine or infectious
* state of immunosuppression
* history of hospitalization (\< 3 months before entrance to the study)
* presence of central venous catheter
* parenteral nutrition
* current pregnancy or intention to become pregnant within 3 months from the entrance to the study
* current lactation
* allergic reaction (\< 3 months before entrance to the study)
* hypersensitivity to yeast, maltodextrins, potato starch, magnesium stearate, hypromellose, gelatin, glycerol or titanium dioxide
* body mass index over 30
* chronic medication use (current or \< 3 months before entrance to the study)
* systemic antibacterial or antifungal medication use (current or \< 3 months before entrance to the study)
* overuse of alcohol or psychoactive substances (current or \< 3 months before entrance to the study)
* tobacco smoking - more than 5 cigarettes (or equivalents) a day (currently or \< 3 months before entrance to the study)
* pro- or prebiotic preparations intake (\< 3 months before entrance to the study)
* vegan or other atypical diet
* doing professional or extreme sports

Primary outcomes:
measure: Performance under examination-related stress
timeFrame: The examination is held on the 30th day of the trial.
Secondary outcomes:
measure: State anxiety under examination-related stress
timeFrame: 30 minutes before the final examination in Basic Medical Pharmacology
measure: Cortisol
timeFrame: Measured a day before the final examination in Basic Medical Pharmacology
measure: Pulse rate
timeFrame: 30 minutes before the final examination in Basic Medical Pharmacology
measure: Metanephrine
timeFrame: Measured a day before the final examination in Basic Medical Pharmacology
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of Lodz
name: Michał S. Karbownik, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dinan TG, Stilling RM, Stanton C, Cryan JF. Collective unconscious: how gut microbes shape human behavior. J Psychiatr Res. 2015 Apr;63:1-9. doi: 10.1016/j.jpsychires.2015.02.021. Epub 2015 Mar 3.
citation: Foster JA, Rinaman L, Cryan JF. Stress & the gut-brain axis: Regulation by the microbiome. Neurobiol Stress. 2017 Mar 19;7:124-136. doi: 10.1016/j.ynstr.2017.03.001. eCollection 2017 Dec.
citation: McFarland LV. Systematic review and meta-analysis of Saccharomyces boulardii in adult patients. World J Gastroenterol. 2010 May 14;16(18):2202-22. doi: 10.3748/wjg.v16.i18.2202.
citation: Karbownik MS, Kreczynska J, Kwarta P, Cybula M, Wiktorowska-Owczarek A, Kowalczyk E, Pietras T, Szemraj J. Effect of Supplementation with Saccharomyces Boulardii on Academic Examination Performance and Related Stress in Healthy Medical Students: A Randomized, Double-Blind, Placebo-Controlled Trial. Nutrients. 2020 May 19;12(5):1469. doi: 10.3390/nu12051469.