HealthyNCT03427515
Probiotics and Examination-related Stress in Healthy Medical Students
A study testing Lactobacillus rhamnosus GG (ATCC 53103) and Saccharomyces boulardii (CNCM I-1079) in people with Healthy and Stress-related Problem, run by Medical University of Lodz.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Stress-related Problem, Anxiety
- What is being tested?
- Lactobacillus rhamnosus GG (ATCC 53103) and Saccharomyces boulardii (CNCM I-1079)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2016to 20 Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being a third year medical student of the Faculty of Medicine or Faculty of Military Medicine, Medical University of Lodz
Who cannot join
- 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
Show all 18Show fewer
- 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
About this study
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
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.
- Conditions
- Healthy, Stress-related Problem, Anxiety
- Being tested
- Lactobacillus rhamnosus GG (ATCC 53103), Saccharomyces boulardii (CNCM I-1079), Placebo
- Keywords
- Psychobiotics, Probiotics, Examination, Stress
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus rhamnosus GG (ATCC 53103)Dietary supplement
30 days of supplementation, 6x10^9 CFU/day
Saccharomyces boulardii (CNCM I-1079)Dietary supplement
30 days of supplementation, 5x10^9 CFU/day
PlaceboDietary supplement
30 days of supplementation
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus | Experimental | Lactobacillus rhamnosus GG (ATCC 53103) - encapsulated Receives: Dietary Supplement: Lactobacillus rhamnosus GG (ATCC 53103) |
| Placebo | Placebo comparator | Placebo - encapsulated mixture of maltodextrins Receives: Dietary Supplement: Placebo |
| Saccharomyces | Experimental | Saccharomyces boulardii (CNCM I-1079) - encapsulated Receives: Dietary Supplement: Saccharomyces boulardii (CNCM I-1079) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance under examination-related stress
Number of correctly-answered questions in the final examination in Basic Medical Pharmacology
Measured: The examination is held on the 30th day of the trial.
Secondary outcomes (4)
State anxiety under examination-related stress
State anxiety measured with State-Trait Anxiety Inventory (STAI)
Measured: 30 minutes before the final examination in Basic Medical Pharmacology
Cortisol
Salivary cortisol level
Measured: Measured a day before the final examination in Basic Medical Pharmacology
Pulse rate
Individual, instructed measurement of pulse rate
Measured: 30 minutes before the final examination in Basic Medical Pharmacology
Metanephrine
Salivary metanephrine level
Measured: Measured a day before the final examination in Basic Medical Pharmacology
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start20 Apr 2016
- Primary completion20 Jun 2016
- Study completion20 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Healthy medical students were assigned
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michal Karbownik, Medical University of Lodz
- Investigators
- Michał S. Karbownik, PhD, Principal investigator, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427515
- Sponsor's protocol ID
- 502-03/5-108-03/502-54-157
- Status last verified
- Feb 2018
- First submitted
- 2 Feb 2018
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25772005Foster 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.
PubMed 29276734McFarland 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.
PubMed 20458757Karbownik 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.
PubMed 32438624
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03427515
- Acronym / sponsor ID
- 502-03/5-108-03/502-54-157
- Conditions
- Healthy, Stress-related Problem, Anxiety
- Keywords
- Psychobiotics, Probiotics, Examination, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 20 Apr 2016 (actual)
- Primary completion
- 20 Jun 2016 (actual)
- Study completion
- 20 Jun 2016 (actual)
- First posted
- 9 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Healthy medical students were assigned
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus | Experimental | Dietary Supplement: Lactobacillus rhamnosus GG (ATCC 53103)Lactobacillus rhamnosus GG (ATCC 53103) - encapsulated |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo - encapsulated mixture of maltodextrins |
| Saccharomyces | Experimental | Dietary Supplement: Saccharomyces boulardii (CNCM I-1079)Saccharomyces boulardii (CNCM I-1079) - encapsulated |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Being a third year medical student of the Faculty of Medicine or Faculty of Military Medicine, Medical University of Lodz
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus rhamnosus GG (ATCC 53103)30 days of supplementation, 6x10^9 CFU/day | Dietary supplement | Lactobacillus |
| Saccharomyces boulardii (CNCM I-1079)30 days of supplementation, 5x10^9 CFU/day | Dietary supplement | Saccharomyces |
| Placebo30 days of supplementation | Dietary supplement | Placebo |
Primary outcome
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
4 secondary outcomes
State anxiety under examination-related stress
Time frame: 30 minutes before the final examination in Basic Medical Pharmacology
Cortisol
Time frame: Measured a day before the final examination in Basic Medical Pharmacology
Pulse rate
Time frame: 30 minutes before the final examination in Basic Medical Pharmacology
Metanephrine
Time frame: Measured a day before the final examination in Basic Medical Pharmacology
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
- Background: PubMed 25772005Dinan 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.
- Background: PubMed 29276734Foster 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.
- Background: PubMed 20458757McFarland 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.
- Derived from this study: PubMed 32438624Karbownik 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michał S. Karbownik, PhD principal investigator
Medical University of Lodz
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus rhamnosus GG (ATCC 53103) and Saccharomyces boulardii (CNCM I-1079) in people with Healthy and Stress-related Problem, run by Medical University of Lodz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance under examination-related stress (time frame: The examination is held on the 30th day of the trial.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03427515, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2018.