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Probiotics and Examination-related Stress in Healthy Medical Students

Effect of Supplementation With Saccharomyces Boulardii and Lactobacillus Rhamnosus on Examination-related Stress in Healthy Medical Students: a Randomised, Double-blind, Placebo-controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03427515
Enrollment
92
Registered
2018-02-09
Start date
2016-04-20
Completion date
2016-06-20
Last updated
2018-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Healthy, Stress-related Problem

Keywords

Psychobiotics, Probiotics, Examination, Stress

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.

Interventions

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

DIETARY_SUPPLEMENTSaccharomyces boulardii (CNCM I-1079)

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

DIETARY_SUPPLEMENTPlacebo

30 days of supplementation

Sponsors

Medical University of Lodz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

Healthy medical students were assigned

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Performance under examination-related stressThe examination is held on the 30th day of the trial.Number of correctly-answered questions in the final examination in Basic Medical Pharmacology

Secondary

MeasureTime frameDescription
State anxiety under examination-related stress30 minutes before the final examination in Basic Medical PharmacologyState anxiety measured with State-Trait Anxiety Inventory (STAI)
CortisolMeasured a day before the final examination in Basic Medical PharmacologySalivary cortisol level
Pulse rate30 minutes before the final examination in Basic Medical PharmacologyIndividual, instructed measurement of pulse rate
MetanephrineMeasured a day before the final examination in Basic Medical PharmacologySalivary metanephrine level

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026