NCT03427515

Probiotics and Examination-related Stress in Healthy Medical Students

Completed NA Last updated 9 February 2018

What this trial tests

NA trial testing Lactobacillus rhamnosus GG (ATCC 53103) in Healthy in 92 participants. Completed in 20 June 2016.

Timeline

20 April 2016

Primary endpoint
20 June 2016

20 June 2016

Quick facts

Lead sponsor	Medical University of Lodz
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	92
Start date	20 April 2016
Primary completion	20 June 2016
Estimated completion	20 June 2016

Drugs / interventions tested

• Lactobacillus rhamnosus GG (ATCC 53103)
• Saccharomyces boulardii (CNCM I-1079)
• Placebo

Conditions studied

• Healthy — all drugs for Healthy →
• Stress-related Problem — all drugs for Stress-related Problem →
• Anxiety — all drugs for Anxiety →

Sponsor

Medical University of Lodz

Who can join

Adults 18 to 30, any sex, with Healthy or Stress-related Problem. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of Supplementation with <i>Saccharomyces Boulardii</i> on Academic Examination Performance and Related Stress in Healthy Medical Students: A Randomized, Double-Blind, Placebo-Controlled Trial.
   Karbownik MS, Kręczyńska J, Kwarta P, Cybula M, et al · · 2020 · cited 14× · PMID 32438624 · DOI 10.3390/nu12051469
2. Decrease in Salivary Serotonin in Response to Probiotic Supplementation With <i>Saccharomyces boulardii</i> in Healthy Volunteers Under Psychological Stress: Secondary Analysis of a Randomized, Double-Blind, Placebo-Controlled Trial.
   Karbownik MS, Kręczyńska J, Wiktorowska-Owczarek A, Kwarta P, et al · · 2021 · cited 7× · PMID 35069447 · DOI 10.3389/fendo.2021.800023