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Probiotics and Examination-related Stress in Healthy Medical Students

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ClinicalTrials.gov Identifier: NCT03427515
Recruitment Status : Completed
First Posted : February 9, 2018
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Michal Karbownik, Medical Universtity 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.


Condition or disease Intervention/treatment Phase
Healthy Stress-related Problem Anxiety Dietary Supplement: Lactobacillus rhamnosus GG (ATCC 53103) Dietary Supplement: Saccharomyces boulardii (CNCM I-1079) Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Healthy medical students were assigned
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : April 20, 2016
Actual Primary Completion Date : June 20, 2016
Actual Study Completion Date : June 20, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lactobacillus
Lactobacillus rhamnosus GG (ATCC 53103) - encapsulated
Dietary Supplement: Lactobacillus rhamnosus GG (ATCC 53103)
30 days of supplementation, 6x10^9 CFU/day

Placebo Comparator: Placebo
Placebo - encapsulated mixture of maltodextrins
Dietary Supplement: Placebo
30 days of supplementation

Experimental: Saccharomyces
Saccharomyces boulardii (CNCM I-1079) - encapsulated
Dietary Supplement: Saccharomyces boulardii (CNCM I-1079)
30 days of supplementation, 5x10^9 CFU/day




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427515


Sponsors and Collaborators
Medical Universtity of Lodz
Investigators
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Principal Investigator: Michał S. Karbownik, PhD Medical University of Lodz

Publications:
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Responsible Party: Michal Karbownik, Research assistant, Medical Universtity of Lodz
ClinicalTrials.gov Identifier: NCT03427515     History of Changes
Other Study ID Numbers: 502-03/5-108-03/502-54-157
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michal Karbownik, Medical Universtity of Lodz:
Psychobiotics
Probiotics
Examination
Stress