Probiotics and Examination-related Stress in Healthy Medical Students

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03427515
• Other study ID #: 502-03/5-108-03/502-54-157
• Status: Completed
• Phase: N/A
• First received: February 2, 2018
• Last updated: February 7, 2018
• Start date: April 20, 2016
• Est. completion date: June 20, 2016

Study information

• Verified date: February 2018
• Source: Medical Universtity of Lodz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: June 20, 2016
• Est. primary completion date: June 20, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Healthy
• Stress-related Problem

Intervention

Dietary Supplement:
• Lactobacillus rhamnosus GG (ATCC 53103)
30 days of supplementation, 6x10^9 CFU/day
• Saccharomyces boulardii (CNCM I-1079)
30 days of supplementation, 5x10^9 CFU/day
• Placebo
30 days of supplementation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical Universtity of Lodz

References & Publications (3)

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. Review. — View Citation

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. Review. — View Citation

McFarland LV. Systematic review and meta-analysis of Saccharomyces boulardii in adult patients. World J Gastroenterol. 2010 May 14;16(18):2202-22. Review. — View Citation

Outcome

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