An interventional study of Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 and Placebo in Healthy, Stress-related Problem and Depression, sponsored by Medical University of Lodz. Completed at 1 site in Poland. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-12.
Sponsored by Medical University of Lodz · Not applicable, Interventional, and Prevention
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 100 is above the median of 84 across 6,720 interventional studies indexed under Depression.
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Exclusion Criteria:
Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 combination probiotic - encapsulated
Dietary Supplement: Lactobacillus helveticus R0052 and Bifidobacterium longum R0175
Mixture of potato starch and magnesium stearate (the excipients that are present in the tested product) - encapsulated
Dietary Supplement: Placebo
8-week supplementation (56 days); 3 × 10\^9 CFU/day
8-week supplementation (56 days)
Cortisol
Salivary cortisol level measured with ELISA test
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 56
Interleukin-1β (IL-1β)
Salivary IL-1β level measured with ELISA test in relation to total protein concentration in saliva
Time frame: Day 0, Day 55
Interleukin-8 (IL-8)
Salivary IL-8 level measured with ELISA test in relation to total protein concentration in saliva
Time frame: Day 0, Day 55
Microbiome
Salivary microbiome assessed with 16S rRNA gene sequencing
Time frame: Day 0, Day 55
Metabolome
Salivary metabolome assessed with liquid chromatography-mass spectrometry
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 0, Day 55
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Medical University of Lodz