Probiotics and Examination-related Stress in Healthy Medical Students

NCT ID: NCT03427515

Last Updated: 2018-02-09

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-20

Study Completion Date

2016-06-20

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Stress-related Problem Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Healthy medical students were assigned
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Lactobacillus

Lactobacillus rhamnosus GG (ATCC 53103) - encapsulated

Group Type EXPERIMENTAL

Lactobacillus rhamnosus GG (ATCC 53103)

Intervention Type DIETARY_SUPPLEMENT

30 days of supplementation, 6x10\^9 CFU/day

Placebo

Placebo - encapsulated mixture of maltodextrins

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

30 days of supplementation

Saccharomyces

Saccharomyces boulardii (CNCM I-1079) - encapsulated

Group Type EXPERIMENTAL

Saccharomyces boulardii (CNCM I-1079)

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

Saccharomyces boulardii (CNCM I-1079)

30 days of supplementation, 5x10\^9 CFU/day

Intervention Type DIETARY_SUPPLEMENT

Placebo

30 days of supplementation

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Lodz

OTHER

Sponsor Role lead

Responsible Party

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Michal Karbownik

Research assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MichaƂ 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.

Reference Type BACKGROUND
PMID: 25772005 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29276734 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20458757 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32438624 (View on PubMed)

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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