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Completed

NCT Number: NCT03427515

Probiotics and Examination-related Stress in Healthy Medical Students

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.

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Key information

Conditions

Healthy Anxiety Anxiety Disorders Mental Disorders Stress-related Problem

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactobacillus rhamnosus GG (ATCC 53103)

Dietary Supplement

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

Saccharomyces boulardii (CNCM I-1079)

Dietary Supplement

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

Placebo

Dietary Supplement

30 days of supplementation

Primary outcomes

  1. Performance under examination-related stress

    Time frame: The examination is held on the 30th day of the trial.

    Number of correctly-answered questions in the final examination in Basic Medical Pharmacology

Secondary outcomes

  1. State anxiety under examination-related stress

    Time frame: 30 minutes before the final examination in Basic Medical Pharmacology

    State anxiety measured with State-Trait Anxiety Inventory (STAI)

  2. Cortisol

    Time frame: Measured a day before the final examination in Basic Medical Pharmacology

    Salivary cortisol level

  3. Pulse rate

    Time frame: 30 minutes before the final examination in Basic Medical Pharmacology

    Individual, instructed measurement of pulse rate

  4. Metanephrine

    Time frame: Measured a day before the final examination in Basic Medical Pharmacology

    Salivary metanephrine level

Sponsors and collaborators

Lead sponsor

Medical University of Lodz

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 9, 2018
Registry last updated
Feb 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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