An interventional study of Lactobacillus rhamnosus GG (ATCC 53103) and Saccharomyces boulardii (CNCM I-1079) in Healthy, Stress-related Problem and Anxiety, sponsored by Medical University of Lodz. Completed. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-09.
Sponsored by Medical University of Lodz · Not applicable, Interventional, and Prevention
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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.
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's enrollment of 92 is above the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Medical University of Lodz is the lead sponsor of 107 studies on the registry; 10 are open to participants now.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lactobacillus rhamnosus GG (ATCC 53103) - encapsulated
Dietary Supplement: Lactobacillus rhamnosus GG (ATCC 53103)
Placebo - encapsulated mixture of maltodextrins
Dietary Supplement: Placebo
Saccharomyces boulardii (CNCM I-1079) - encapsulated
Dietary Supplement: Saccharomyces boulardii (CNCM I-1079)
30 days of supplementation, 6x10\^9 CFU/day
30 days of supplementation, 5x10\^9 CFU/day
30 days of supplementation
Performance under examination-related stress
Number of correctly-answered questions in the final examination in Basic Medical Pharmacology
Time frame: The examination is held on the 30th day of the trial.
State anxiety under examination-related stress
State anxiety measured with State-Trait Anxiety Inventory (STAI)
Time frame: 30 minutes before the final examination in Basic Medical Pharmacology
Cortisol
Salivary cortisol level
Time frame: Measured a day before the final examination in Basic Medical Pharmacology
Pulse rate
Individual, instructed measurement of pulse rate
Time frame: 30 minutes before the final examination in Basic Medical Pharmacology
Metanephrine
Salivary metanephrine level
Time frame: Measured a day before the final examination in Basic Medical Pharmacology
No study locations are listed for this record.
Ran from Apr 2016 to primary completion in Jun 2016, 2 months.
Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 2 months is below that.
Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lacticaseibacillus rhamnosus GG