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| Name | Class |
|---|---|
| Pomeranian Medical University Szczecin | OTHER |
| SANPROBI Sp. z o.o. Sp.k. | UNKNOWN |
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Probiotics are "live microorganisms which when administered in adequate amounts confer a health benefit on the host". Accumulating evidence indicates their effect in mental health restoration. Beneficial neuropsychological and psychobiological effects are particularly well substantiated in clinical samples. However, it is not clearly documented whether probiotic supplementation reduces depressive and anxiety symptoms in healthy volunteers experiencing temporal deterioration in mental functioning while facing a stressful event. The combination of Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 is particularly well studied in terms of its central nervous system action with significantly deciphered mechanism. As a result, this combination is particularly promising to study the effect of mental health improvement in healthy volunteers facing a stressful event.
The aim of this project is to assess the impact of a 8-week supplementation with probiotic combination of Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 strains in the daily dose of 3 × 10^9 colony forming units on mental health measures and oral microbiota composition and metabolome in healthy young adults facing a psychologically stressful event. The aim will be achieved by comparing the probiotic combination supplement to placebo in a randomized triple-blind controlled trial settings with a participant allocation ratio of 1:1.
The summer academic examination session and the upcoming first take of the final exam in pharmacology at third year of medical studies will be a model of a stressful event. The participants will supplement their diets with probiotic/placebo for 8 weeks before the exam. After giving written informed consent, before the supplementation (relatively stress-free time period in terms of academic activities) the participants will provide background sociodemographic, anthropometric and psychometric data. At that time, participants will also give samples of saliva to assess cortisol and selected cytokines concentrations as well as salivary microbiome and metabolome. At the end of supplementation, a day before the final exam, participants will donate salivary samples and do psychometric tests for the second time to assess the same parameters as at the beginning of the study. Participants will also do a pre-exam test in pharmacology (not considered a formal academic assessment) as a comparator for the results of the formal examination held a day after.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 combination probiotic - encapsulated |
|
| Placebo | Placebo Comparator | Mixture of potato starch and magnesium stearate (the excipients that are present in the tested product) - encapsulated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 | Dietary Supplement | 8-week supplementation (56 days); 3 × 10^9 CFU/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cortisol | Salivary cortisol level measured with ELISA test | Day 0, Day 55 |
| Depression symptoms under examination-related stress | Depression symptoms measured with Depression Anxiety Stress Scale - 21 (DASS-21). Seven items, each scored 0 to 3 points, yielding a total between 0 and 21 points. The more points the more severe depression. | Day 0, Day 55 |
| Anxiety symptoms under examination-related stress | Anxiety symptoms measured with Depression Anxiety Stress Scale - 21 (DASS-21). Seven items, each scored 0 to 3 points, yielding a total between 0 and 21 points. The more points the more severe anxiety. | Day 0, Day 55 |
| Stress symptoms under examination-related stress | Stress symptoms measured with Depression Anxiety Stress Scale - 21 (DASS-21). Seven items, each scored 0 to 3 points, yielding a total between 0 and 21 points. The more points the more severe stress. | Day 0, Day 55 |
| Performance under examination-related stress | Number of correctly-answered questions in the final examination in pharmacology in relation to subject knowledge assessed in the pre-exam test. 60 questions, each scored 0 or 1 point, yielding a total between 0 and 60 points. The more points the better performance under examination-related stress. | Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Interleukin-1β (IL-1β) | Salivary IL-1β level measured with ELISA test in relation to total protein concentration in saliva | Day 0, Day 55 |
| Interleukin-8 (IL-8) | Salivary IL-8 level measured with ELISA test in relation to total protein concentration in saliva |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michał S. Karbownik, PhD | Medical University of Lodz | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Lodz | Lodz | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20974015 | Background | Messaoudi M, Lalonde R, Violle N, Javelot H, Desor D, Nejdi A, Bisson JF, Rougeot C, Pichelin M, Cazaubiel M, Cazaubiel JM. Assessment of psychotropic-like properties of a probiotic formulation (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175) in rats and human subjects. Br J Nutr. 2011 Mar;105(5):755-64. doi: 10.1017/S0007114510004319. Epub 2010 Oct 26. | |
| 24372793 |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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Healthy medical students are assigned
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| Placebo | Dietary Supplement | 8-week supplementation (56 days) |
|
| Day 0, Day 55 |
| Microbiome | Salivary microbiome assessed with 16S rRNA gene sequencing | Day 0, Day 55 |
| Metabolome | Salivary metabolome assessed with liquid chromatography-mass spectrometry | Day 0, Day 55 |
| Mood | Current mood measured with a pictogram-enhanced visual analog mood scale. A single item scored 0 to 10 points, yielding a total between 0 and 10 points. The more points the better mood. | Day 0, Day 55 |
| Depression symptoms under examination-related stress (supportive measure) | Depression symptoms measured with Patient Health Questionnaire - 9 (PHQ-9). Nine items, each scored 0 to 3 points, yielding a total between 0 and 27 points. The more points the more severe depression. | Day 0, Day 55 |
| Anxiety symptoms under examination-related stress (supportive measure) | Anxiety symptoms measured with General Anxiety Disorder - 7 (GAD-7). Seven items, each scored 0 to 3 points, yielding a total between 0 and 21 points. The more points the more severe anxiety. | Day 0, Day 55 |
| Sleep quality under examination-related stress | Sleep quality status measured with Pittsburgh Sleep Quality Index (PSQI). Seven components, each scored 0 to 3 points, yielding a total composite score of 0 to 21 points. The more points the more sleep difficulties. | Day 0, Day 55 |
| Fatigue under examination-related stress | Fatigue status measured with Fatigue Severity Scale (FSS). Nine items, each scored 1 to 7 points, yielding a total between 7 and 63 points. The more points the greater fatigue severity. | Day 0, Day 55 |
| Background |
| Ait-Belgnaoui A, Colom A, Braniste V, Ramalho L, Marrot A, Cartier C, Houdeau E, Theodorou V, Tompkins T. Probiotic gut effect prevents the chronic psychological stress-induced brain activity abnormality in mice. Neurogastroenterol Motil. 2014 Apr;26(4):510-20. doi: 10.1111/nmo.12295. Epub 2013 Dec 30. |
| 29291614 | Background | Ait-Belgnaoui A, Payard I, Rolland C, Harkat C, Braniste V, Theodorou V, Tompkins TA. Bifidobacterium longum and Lactobacillus helveticus Synergistically Suppress Stress-related Visceral Hypersensitivity Through Hypothalamic-Pituitary-Adrenal Axis Modulation. J Neurogastroenterol Motil. 2018 Jan 30;24(1):138-146. doi: 10.5056/jnm16167. |
| 32528399 | Background | Chao L, Liu C, Sutthawongwadee S, Li Y, Lv W, Chen W, Yu L, Zhou J, Guo A, Li Z, Guo S. Effects of Probiotics on Depressive or Anxiety Variables in Healthy Participants Under Stress Conditions or With a Depressive or Anxiety Diagnosis: A Meta-Analysis of Randomized Controlled Trials. Front Neurol. 2020 May 22;11:421. doi: 10.3389/fneur.2020.00421. eCollection 2020. |
| 32438624 | Background | 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. |