Probiotics and Examination-related Stress in Healthy Medical Students
NCT ID: NCT03427515
Last Updated: 2018-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
92 participants
INTERVENTIONAL
2016-04-20
2016-06-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Lactobacillus
Lactobacillus rhamnosus GG (ATCC 53103) - encapsulated
Lactobacillus rhamnosus GG (ATCC 53103)
30 days of supplementation, 6x10\^9 CFU/day
Placebo
Placebo - encapsulated mixture of maltodextrins
Placebo
30 days of supplementation
Saccharomyces
Saccharomyces boulardii (CNCM I-1079) - encapsulated
Saccharomyces boulardii (CNCM I-1079)
30 days of supplementation, 5x10\^9 CFU/day
Interventions
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Lactobacillus rhamnosus GG (ATCC 53103)
30 days of supplementation, 6x10\^9 CFU/day
Saccharomyces boulardii (CNCM I-1079)
30 days of supplementation, 5x10\^9 CFU/day
Placebo
30 days of supplementation
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
30 Years
ALL
Yes
Sponsors
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Medical University of Lodz
OTHER
Responsible Party
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Michal Karbownik
Research assistant
Principal Investigators
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MichaĆ S. Karbownik, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Lodz
References
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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.
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.
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.
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.
Other Identifiers
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502-03/5-108-03/502-54-157
Identifier Type: -
Identifier Source: org_study_id
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