NCT03427515

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed
Last Updated

February 9, 2018

Status Verified

February 1, 2018

Enrollment Period

2 months

First QC Date

February 2, 2018

Last Update Submit

February 7, 2018

Conditions

HealthyStress-related ProblemAnxiety

Keywords

PsychobioticsProbioticsExaminationStress

Outcome Measures

Primary Outcomes (1)

  • Performance under examination-related stress

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

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

Secondary Outcomes (4)

  • State anxiety under examination-related stress

    30 minutes before the final examination in Basic Medical Pharmacology

  • Cortisol

    Measured a day before the final examination in Basic Medical Pharmacology

  • Pulse rate

    30 minutes before the final examination in Basic Medical Pharmacology

  • Metanephrine

    Measured a day before the final examination in Basic Medical Pharmacology

Study Arms (3)

Lactobacillus

EXPERIMENTAL

Lactobacillus rhamnosus GG (ATCC 53103) - encapsulated

Dietary Supplement: Lactobacillus rhamnosus GG (ATCC 53103)

Placebo

PLACEBO COMPARATOR

Placebo - encapsulated mixture of maltodextrins

Dietary Supplement: Placebo

Saccharomyces

EXPERIMENTAL

Saccharomyces boulardii (CNCM I-1079) - encapsulated

Dietary Supplement: Saccharomyces boulardii (CNCM I-1079)

Interventions

Lactobacillus rhamnosus GG (ATCC 53103)DIETARY_SUPPLEMENT

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

Lactobacillus
Saccharomyces boulardii (CNCM I-1079)DIETARY_SUPPLEMENT

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

Saccharomyces
PlaceboDIETARY_SUPPLEMENT

30 days of supplementation

Placebo

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 25772005BACKGROUND

  • 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.

    PMID: 29276734BACKGROUND

  • 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.

    PMID: 20458757BACKGROUND

  • 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.

    PMID: 32438624DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Michał S. Karbownik, PhD

    Medical University of Lodz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Healthy medical students were assigned
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

February 2, 2018

First Posted

February 9, 2018

Study Start

April 20, 2016

Primary Completion

June 20, 2016

Study Completion

June 20, 2016

Last Updated

February 9, 2018

Record last verified: 2018-02