Probiotics and Examination-related Stress in Healthy Medical Students

Not Applicable

Completed

• Conditions: Anxiety; Healthy; Stress-related Problem
• Interventions: Dietary Supplement: Lactobacillus rhamnosus GG (ATCC 53103); Dietary Supplement: Placebo; Dietary Supplement: Saccharomyces boulardii (CNCM I-1079)

• Registration Number: NCT03427515
• Lead Sponsor: Medical University of Lodz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-20
• Primary Completion: 2016-06-20
• Study Completion: 2016-06-20
• Status Verified: 2018-02
• Study First Submitted: 2018-02-02
• Study First Submitted QC: 2018-02-07
• Last Update Submitted: 2018-02-07
• Study First Posted: 2018-02-09
• Last Update Posted: 2018-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactobacillus	Lactobacillus rhamnosus GG (ATCC 53103)	Lactobacillus rhamnosus GG (ATCC 53103) - encapsulated
Placebo	Placebo	Placebo - encapsulated mixture of maltodextrins
Saccharomyces	Saccharomyces boulardii (CNCM I-1079)	Saccharomyces boulardii (CNCM I-1079) - encapsulated

Primary Outcome Measures

Name	Time	Method
Performance under examination-related stress	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 Outcome Measures

Name	Time	Method
Cortisol	Measured a day before the final examination in Basic Medical Pharmacology	Salivary cortisol level
State anxiety under examination-related stress	30 minutes before the final examination in Basic Medical Pharmacology	State anxiety measured with State-Trait Anxiety Inventory (STAI)
Pulse rate	30 minutes before the final examination in Basic Medical Pharmacology	Individual, instructed measurement of pulse rate
Metanephrine	Measured a day before the final examination in Basic Medical Pharmacology	Salivary metanephrine level