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The aim of the planned research is to assess the dynamics of changes in the elements of the gut-brain axis (GBA), the cytokine profile and the endocannabinoid system markers, after dietary supplementation with probiotics Lactobacillus helveticus Rosell-52 and Bifidobacterium longum Rosell-175 by professional dancers. Although in recent years there has been growing interest in the influence of the gut microbiota on the body's adaptation to stress stimuli and on overall health, there is a lack of information on the influence of probiotics on systems involved in maintaining neuropsychiatric balance, such as the endocannabinoid system.
In order to determine the validity of the applied therapy with selective probiotics, the following will be assessed: intestinal bacteria and bacterial metabolites in the stool, cannabinoids and cannabinoid receptors and enzymes in the blood, indicators of mental distress in the blood, cytokines responsible for the modulation of the gut-brain axis in the blood, as well as questionnaires regarding the functioning of the digestive tract, fatigue, stress and sleep quality.
The study will involve active dancers of the Polish Theater in Poznan, the Polish Dance Theater, the Private School of Dance Art in Poznan and students of the Academy of Physical Education in the field of Dance. Dancers are a group of athletes that is exposed to particular injuries and work-overload. Professional dancers spend multiple hours a week on intensive physical training. The largest percentage of injuries occurring in the group of professional dancers are chronic injuries, including: inflammation of soft tissues, muscle strains and tears.
Professional dance is one of the most physically demanding forms of physical activity, and at the same time it is associated with a high burden on the nervous system problems caused by performances in front of an audience or subjective jury, frequent traveling and disturbances in the circadian rhythm.
Professional dancers are often referred to as artistic athletes due to their high level of physical activity and competition. Training dance for over 11.5 hours a week increases the risk of injury (women - mostly bone injuries, men - mostly bruises and tendon injuries). One of the reasons for the increased susceptibility to injuries among dancers is psychological stress. The observations results indicate that dancers often decide to continue training despite feeling pain, which limits the smoothness of their movements and leads to a further increase of stress. Highly physically active groups of people are more exposed to functional dyspepsia (FD) and irritable bowel syndrome (IBS), which occurence is correlated to chronic stress. As a result of chronic stress and the activation of the hypothalamic pituitary-adrenal axis (HPA), inflammatory processes in the gastrointestinal mucosa are initiated. The presence of noradrenaline increases the adhesion of bacteria and viruses to the epithelium, which in turn modulates the immune system within the intestines and increases their inflammation. Systemically acting cortisol causes the leakage of tight junctions (TJ) cells and an increase in the permeability of the intestinal barrier. Inflammation stimulates the secretion of cortisol, which initiates the further cycle of inflammation and weakening of the intestinal barrier function. As a consequence, cytokines and inflammatory mediators released in the course of inflammation act directly on the nerve endings that transmit these afferent nerve signals to the brain, becoming an endogenous stressor.
When exogenous and endogenous stress factors overlap, the body's perception of stress increases, which ultimately leads to psychological, physiological and behavioral changes.
Pain and depression are common comorbidities of neuropsychiatric origin. One of the body's regulatory systems, which in both cases is dysfunctional, is the endocannabinoid system (ECS). It has been suggested that these diseases can be caused by intense and prolonged exercise, which disrupts the intestinal barrier, causing changes in the profile of metabolites and the function of the intestinal microbiota. Overtraining leads to an increase in the levels of cortisol, adrenaline and noradrenaline, and to the translocation of lipopolysaccharide (LPS) outside the gut, increasing the concentration of pro-inflammatory cytokines in the body. This results in dysregulation of the balance between serotonin (5-HT), dopamine (DA) and gamma-aminobutyric acid (GABA) and fatigue. These changes lead to further activation of the endocannabinoid system and, in the long-term, weakening of adaptive abilities.
The neuromodulatory properties of the cannabinoid system are manifested e.g. in short- and long-term synaptic plasticity and modulation of pain conduction. Research results indicate that the endocannabinoid system, in addition to its key role in regulating intestinal motility, also affects the secretory functions of the gastrointestinal tract and the integrity of the intestinal epithelium, which may be an alternative way to regulate the immune system and inflammation in the intestines.
Type 1 cannabinoid receptors (CB1) are located presynaptically in the cell membrane of central and peripheral nervous system neurons, and their activation inhibits the release of many neurotransmitters, i.e. acetylcholine, noradrenaline, dopamine, serotonin, glutamate and γ-aminobutyric acid. Type 2 cannabinoid receptors (CB2) are found mainly on the surface of cells of the immune system, especially B-lymphocytes, macrophages and monocytes. Their activation inhibits pro-inflammatory cytokines release and increases the release of anti-inflammatory cytokines.
Cannabinoid receptors are found in both, the immune and digestive systems. Endogenous cannabinoids modify the body's response to stress by influencing the hypothalamic pituitary-adrenal axis (HPA). Stress leads to an increased activity of endocannabinoids which, mainly through the CB1 cannabinoid receptors, lead to the inhibition of the release of corticosteroids. In addition, the activation of CB1 receptors in the gastrointestinal tract reduces the intensity of pain conduction (nociception), which is induced by activation, e.g. TRPV1 vanilloid receptors. It has been shown that inflammation within the intestinal epithelium of the gastrointestinal tract causes an increase in the neural conduction of neurons containing CB1 receptors, which contributes to a change in the proportion of these receptors in relation to the TRPV1 located mainly in the cell membrane of dorsal root ganglion afferents (DRGs). As a result, two different receptors interact and the TRPV1 receptor activity is abolished. Inflammatory mediators released from the intestinal epithelium stimulate visceral pain, while activation of CB2 receptors probably reduces their action.
There are indications that a qualitative and quantitative change in the intestinal microbiota may affect the activity of endogenous ligands and mediators of the endocannabinoid system (ECS). Although the mechanisms of regulation of the level of endocannabinoids and related bioactive lipids by selected bacteria are not fully understood, it has been shown that probiotic supplementation can induce an increase in the concentration of endogenous cannabinoids, i.e. 2-AG (2-arachidonoylglycerol), 2-OG (2-oleoylglycerol) and 2-PG (2-palmitoylglycerol). In an animal experiment, the use of monoacylglycerol lipase inhibition reduced the degradation of 2-AG, which reduced endotoxemia and systemic inflammation. In another study, the deletion of the Myd88 gene encoding the TLR (toll-like receptor) receptor protein in intestinal epithelial cells changed the composition of the intestinal microbiota, decreased the synthesis of anandamide (AEA) and increased the synthesis of anti-inflammatory endocannabinoids, such as: 2-AG, 2-PG, 2 OG. Released endocannabinoids with anti-inflammatory properties have the ability to activate so-called orphan GPR119 (G protein-coupled receptor 119) receptors, which are associated with the secretion of anti-inflammatory mediators. Moreover, it has been shown that an increase in LPS concentration induces AEA synthesis and a decrease in fatty-acid amide hydrolase (FAAH) in macrophages, as well as an increase in AEA production in peripheral lymphocytes, which may be important for the regulation of the intestinal barrier function and the level of inflammation. The results of studies carried out on a mouse model revealed the importance of the intestinal microbiota in the regulation of the expression of the NAPE-PLD gene (phospholipase D specific for n-acylphosphatidylethanolamine), i.e. an enzyme involved in the synthesis of anandamide and in the selective regulation of CB1 mRNA (messenger ribonucleic acid) expression. In an obese mouse model, it was observed that the administration of a probiotic decreased the expression level of CB1 receptor mRNA while reducing the concentration of AEA ligand and increasing the expression of FAAH mRNA. In other studies, administration of a probiotic to mice resulted in a decrease in the concentration of LPS in the blood plasma, which correlated with both the level of AEA and the expression of CB1 mRNA in the colon epithelium. In in vitro and in vivo experiments on animal models, it has been observed that CB2 receptors are activated when an imbalance in the innate immune system occurs. The NLRP3 inflammasomes are suppressed by autophagy, a mechanism that may be involved in the suppression of inflammation and the regulation of the intestinal barrier, e.g. in irritable bowel syndrome. Another factor that is a potential NLRP3 inhibitor is the intestinal microbiota metabolite, butyrate, which belongs to the short-chain fatty acids. Its action has a positive effect on the functions of the intestinal epithelial cells and the stability of the intestinal barrier. In studies conducted on germ-free mice, after the intestinal microbiota was transferred, the metabolism of endocannabinoids in the gastrointestinal tract changed. The use of probiotic therapy in mice with previously induced intestinal dysbiosis changed the activation of endocannabinoid receptors, the behavior of animals and a decrease in intestinal inflammation. Other research results indicate that inhibition of the CB1 receptor in obese mice stimulates the secretion of mucin, which is the primary source of nutrients for the development of Akkermansia muciniphila. This observation confirms the results of studies by other authors, who demonstrated the possibility of regulation of CB2 receptors by some species of intestinal bacteria and the related immune response.
The mechanisms of the transmission of inflammatory signals from the gut to the CNS (central nervous system) are not fully elucidated. The results of the research indicate, however, that the systemic inflammation accompanying depressive symptoms is associated with changes in the ecosystem of the intestinal microbiota and the production of SCFA (short-chain fatty acids) and other metabolites of a neurobiological nature. Moreover, it can also lead to changes in the synthesis and release of endocannabinoids or the metabolic pathways of tryptophan and kynurenine (KYN). So far, it has been observed that there is a link between ECS and the kynurenine pathway in neurological disorders such as epilepsy or migraine headaches, which are associated with excessive cell stimulation and excitotoxicity. The latest research results indicate the possibility of modifying the transformations of tryptophan and kynurenine by probiotic therapy.
There is limited number of human research on the role of the gut microbiota in the modulation of the ECS. The available literature lacks studies describing the relationship of changes in the intestinal microbiota and its metabolome under the influence of targeted, multi-strain probiotic therapy on the response of the endocannabinoid and immune system in people subjected to high physical and mental stress. Observations that will be made in dancers supplemented with a multi strain probiotic containing Lactobacillus helveticus Rosell-52 and Bifidobacterium longum Rosell-175 may help finding effective tools in the treatment of gastrointestinal disorders and stress related to it. A potential mechanism behind this action may be the restoration of the normal gut microbiota and the profile of its metabolites, as well as the improvement of the gut barrier and endocannabinoid function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic treatment group | Experimental | ca. 30 participants |
|
| Placebo group | Placebo Comparator | ca. 30 participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus helveticus Rosell-52 and Bifidobacterium longum Rosell-175 (Sanprobi Stress) | Dietary Supplement | 3-month, multi-strain probiotic supplementation (one a day, 3 x 10⁹ CFU) |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative Assessment of Intestinal Microbiota in Stool Samples | • gut bacteria species in stool will be assessed using the shallow shotgun sequencing method, NGS (Next-Generation Sequencing); | Baseline and 3 months |
| Quantitive Change in Intestinal Microbiota in Stool Samples | • determination of quantitative (Colony forming units - CFU) changes in bacteria in the stool - the shallow shotgun sequencing method, NGS (Next Generation Sequencing) molecular analysis will be used to assess the changes; | Baseline and 3 months |
| Intestinal Metabolome in Stool Samples | Metabolites with fold change >1.5 and p<0.05 were considered significantly altered. The reported values represent the number of metabolites meeting these criteria in the probiotic group. • metabolomic analysis (non-targeted metabolome, short-chain fatty acids, trimethylamines, tryptophan catabolites) will be performed on a quadrupole mass spectrometer coupled with a time-of-flight (QToF) analyzer connected to the high performance liquid chromatograph (UHPLC). | Baseline and 3 months |
| Quantitive Change in Endocannabinoids Levels in Blood Samples | • determination of endocannabinoids and cannabinoid receptors: anandamide (AEA) using ELISA Kit (nanograms per millilitre (ng/mL)); | Baseline and 3 months |
| Quantitive Change in Endocannabinoids' Receptors Levels in Blood Samples | • determination of cannabinoid receptors: Endocannabinoid Receptor 2 (CNR2) using ELISA Kit (nanograms per millilitre (ng/mL)); | Baseline and 3 months |
| Quantitive Change in Endocannabinoids Metabolism Enzymes in Blood |
| Measure | Description | Time Frame |
|---|---|---|
| Coping With Stress Questionnaire | • determination of methods of active coping with stress using the Inventory for Measuring Coping with Stress (Mini-COPE); It is designed to establish how a study participant behaves when experiences particular events; The scale: 0 = "I hardly ever do this", 1 = "I rarely do this", 2 = "I do this often", 3 = "I almost always do this"; [0-18] - higher scores mean better outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanna Karolkiewicz, Professor | Poznan University of Physical Education | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poznan University of Physical Education | Poznan | 61-871 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28439004 | Background | Acharya N, Penukonda S, Shcheglova T, Hagymasi AT, Basu S, Srivastava PK. Endocannabinoid system acts as a regulator of immune homeostasis in the gut. Proc Natl Acad Sci U S A. 2017 May 9;114(19):5005-5010. doi: 10.1073/pnas.1612177114. Epub 2017 Apr 24. | |
| 24684963 | Background | Alhouayek M, Muccioli GG. COX-2-derived endocannabinoid metabolites as novel inflammatory mediators. Trends Pharmacol Sci. 2014 Jun;35(6):284-92. doi: 10.1016/j.tips.2014.03.001. Epub 2014 Mar 29. |
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Although 20 participants were randomized and assigned to groups (8 in PRO, 12 in PLA), only 17 completed the study. Three withdrew before receiving the intervention or failed to follow-up. The Protocol Enrollment field reflects only the final number analyzed per protocol.
A total of 51 female dancers were screened; 26 met inclusion criteria (age 18-36, >8 hours of weekly training). Twenty-five were excluded due to recent illness, supplementation, medication, or travel. Participation was challenging due to dancers' long training hours, performances, and irregular schedules, limiting availability for fasting blood draws and timely stool sample delivery. As only two men applied, the final sample included women only to avoid sex-related bias in microbiome outcomes.
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| ID | Title | Description |
|---|---|---|
| FG000 | Probiotic Treatment Group (PRO) | Final sample: 5 participants (out of ~30 originally planned). Lactobacillus helveticus Rosell-52 and Bifidobacterium longum Rosell-175 (Sanprobi Stress): 3-month, multi-strain probiotic supplementation (one capsule daily, 3 × 10⁹ CFU). Note: Several participants withdrew or were excluded due to non-adherence or outlier data (e.g., failure to start supplementation, extreme biochemical values). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 28, 2025 |
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a Randomized, Double-blind, Placebo-controlled Study
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| Starch (placebo) | Dietary Supplement | 3-month placebo |
|
|
• determination of cannabinoid metabolism enzymes: fatty acid amide hydrolase (FAAH) using ELISA Kit (nanograms per millilitre (ng/mL)); |
| Baseline and 3 months |
| Quantitive Change in Intestinal Barrier Proteins in Blood Samples | • determination of blood biomarkers of a disturbed intestinal barrier concentrations: zonulin, calprotectin (CALPRO) using ELISA Kit (nanograms per millilitre (ng/mL)); | Baseline and 3 months |
| Quantitive Change in Intestinal Barrier Biomarkers in Blood Samples | • determination of blood biomarkers of a disturbed intestinal barrier concentrations: lipopolysaccharide (LPS), using ELISA Kit (picograms per millilitre (pg/mL)); | Baseline and 3 months |
| Quantitive Change in Tumor Necrosis Factor-alpha (TNF-α) in Blood Samples | • determination of blood tumor necrosis factor-alpha (TNF-α) concentration using ELISA Kit (nanograms per millilitre (ng/mL)); | Baseline and 3 months |
| Quantitive Change in Leukemia Inhibitory Factor (LIF) in Blood Samples | • determination of blood leukemia inhibitory factor (LIF) concentration using ELISA Kit (nanograms per millilitre (ng/mL)); | Baseline and 3 months |
| Quantitive Change in Blood Interleukins Profile | • determination of interleukins concentrations: IL-1β (interleukin-1beta), using ELISA Kit (picograms per millilitre (pg/mL)); | Baseline and 3 months |
| Quantitive Change in Chronic Stress Biomarker in Blood Samples - Cortisol | • determination of blood cortisol concentration using ELISA Kit (nanograms per millilitre (ng/mL)) - Instead of cortisol, IL-10 levels were analyzed as a marker of anti-inflammatory response [pg/mL]. | Baseline and 3 months |
| Quantitive Change in Inflammation Biomarker in Blood Samples - C-reactive Protein | • determination of C-reactive protein (CRP) concentration using ELISA Kit (picograms per millilitre (pg/mL)); | Baseline and 3 months |
| Baseline and 3 months |
| Fatigue Questionnaire | • assessment of the level of fatigue using the Fatigue Assessment Scale (FAS); the statements of the questionnaire relate to the feeling of well-being; The scale: 1. Never (0 points), 2. Sometimes (once a month or less) (1 point), 3. Regularly (several times a month) (2 points), 4. Often (weekly)(3 points) and 5. Always (everyday) (4 points); [0-32] - higher score means worse outcome | Baseline and 3 months |
| Gastrointestinal Disorders Questionnaire | • assessment of gastrointestinal pain using the Rome IV Questionnaire for adults (selected questions on irritable bowel syndrome, constipation and diarrhea); the statements of the questionnaire relate to frequency and intensity of disorders; [0-10] - higher scores mean worse outcome; | Baseline and 3 months |
| Sleep Quality Questionnaire | • assessment of the sleep quality level using Pittsburgh Sleep Quality Questionnaire (PSQI); the statements of the questionnaire relate to frequency of sleep disorders; [0-3] - higher scores mean worse outcome; | Baseline and 3 months |
| Body Mass Analysis (BMI, kg/m^2) | • determination of body weight and composition using the electrical bioimpedance method; | Baseline and 3 months |
| Body Composition Analysis (Percent of Total Body Mass) | • assessment of bone, fat and fat-free mass using the electrical bioimpedance method; | Baseline and 3 months |
| Composite Measure of Diet Composition Assessed by Food Diaries | • assessment of protein, fat, carbohydrates and fibre intake using food diaries (grams); | Baseline and 3 months |
| Pain Threshold Test (Newtons) | • mechanical stimuli pain threshold assessment using an algometer. Mechanical pressure pain threshold was assessed on the thumb flexor muscle using a pressure algometer. The probe was applied perpendicularly with gradually increasing pressure until the participant indicated the first painful sensation. Three consecutive measurements were performed, and the mean value in Newtons was recorded as the outcome. | Baseline and 3 months |
| Changes in Red Blood Cells Count | • determination of red blood cell counts using flow cytometry (trillion cells per Litre); | Baseline and 3 months |
| Changes in White Blood Cells Count | • determination of white blood cells counts using flow cytometry (billion cells per Litre); | Baseline and 3 months |
| Changes in Hemoglobin Level | • determination of hemoglobin level using flow cytometry (grams per Litre); | Baseline and 3 months |
| Changes in Hematocrit | • determination of hematocrit using flow cytometry (percentage of red blood cells in blood); | Baseline and 3 months |
| Changes in Platelets Counts | • determination of platelets counts using flow cytometry (billions per Litre) | Baseline and 3 months |
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| 30388595 | Background | Rudzki L, Ostrowska L, Pawlak D, Malus A, Pawlak K, Waszkiewicz N, Szulc A. Probiotic Lactobacillus Plantarum 299v decreases kynurenine concentration and improves cognitive functions in patients with major depression: A double-blind, randomized, placebo controlled study. Psychoneuroendocrinology. 2019 Feb;100:213-222. doi: 10.1016/j.psyneuen.2018.10.010. Epub 2018 Oct 16. |
| 35124451 | Background | Russo F, Tolomeo F, Vandelli MA, Biagini G, Paris R, Fulvio F, Lagana A, Capriotti AL, Carbone L, Gigli G, Cannazza G, Citti C. Kynurenine and kynurenic acid: Two human neuromodulators found in Cannabis sativa L. J Pharm Biomed Anal. 2022 Mar 20;211:114636. doi: 10.1016/j.jpba.2022.114636. Epub 2022 Jan 31. |
| 28398468 | Background | Saary P, Forslund K, Bork P, Hildebrand F. RTK: efficient rarefaction analysis of large datasets. Bioinformatics. 2017 Aug 15;33(16):2594-2595. doi: 10.1093/bioinformatics/btx206. |
| 25417929 | Background | Shao BZ, Wei W, Ke P, Xu ZQ, Zhou JX, Liu C. Activating cannabinoid receptor 2 alleviates pathogenesis of experimental autoimmune encephalomyelitis via activation of autophagy and inhibiting NLRP3 inflammasome. CNS Neurosci Ther. 2014 Dec;20(12):1021-8. doi: 10.1111/cns.12349. |
| 30937839 | Background | Shao BZ, Wang SL, Pan P, Yao J, Wu K, Li ZS, Bai Y, Linghu EQ. Targeting NLRP3 Inflammasome in Inflammatory Bowel Disease: Putting out the Fire of Inflammation. Inflammation. 2019 Aug;42(4):1147-1159. doi: 10.1007/s10753-019-01008-y. |
| 33139656 | Background | Skonieczna-Zydecka K, Jakubczyk K, Maciejewska-Markiewicz D, Janda K, Kazmierczak-Siedlecka K, Kaczmarczyk M, Loniewski I, Marlicz W. Gut Biofactory-Neurocompetent Metabolites within the Gastrointestinal Tract. A Scoping Review. Nutrients. 2020 Nov 1;12(11):3369. doi: 10.3390/nu12113369. |
| 18671715 | Background | Smid SD. Gastrointestinal endocannabinoid system: multifaceted roles in the healthy and inflamed intestine. Clin Exp Pharmacol Physiol. 2008 Nov;35(11):1383-7. doi: 10.1111/j.1440-1681.2008.05016.x. Epub 2008 Jul 29. |
| 30554372 | Background | Yu W, Jin G, Zhang J, Wei W. Selective Activation of Cannabinoid Receptor 2 Attenuates Myocardial Infarction via Suppressing NLRP3 Inflammasome. Inflammation. 2019 Jun;42(3):904-914. doi: 10.1007/s10753-018-0945-x. |
| 26234821 | Background | Wang X, He G, Peng Y, Zhong W, Wang Y, Zhang B. Sodium butyrate alleviates adipocyte inflammation by inhibiting NLRP3 pathway. Sci Rep. 2015 Aug 3;5:12676. doi: 10.1038/srep12676. |
| 17906675 | Background | Wright KL, Duncan M, Sharkey KA. Cannabinoid CB2 receptors in the gastrointestinal tract: a regulatory system in states of inflammation. Br J Pharmacol. 2008 Jan;153(2):263-70. doi: 10.1038/sj.bjp.0707486. Epub 2007 Oct 1. |
| 34803856 | Background | van Winden D, van Rijn RM, Savelsbergh GJP, Oudejans RRD, Stubbe JH. The Association Between Stress and Injury: A Prospective Cohort Study Among 186 First-Year Contemporary Dance Students. Front Psychol. 2021 Nov 5;12:770494. doi: 10.3389/fpsyg.2021.770494. eCollection 2021. |
| 27133395 | Background | Sharkey KA, Wiley JW. The Role of the Endocannabinoid System in the Brain-Gut Axis. Gastroenterology. 2016 Aug;151(2):252-66. doi: 10.1053/j.gastro.2016.04.015. Epub 2016 Apr 29. |
| 38891799 | Derived | Wiacek J, Podgorski T, Kusy K, Loniewski I, Skonieczna-Zydecka K, Karolkiewicz J. Evaluating the Impact of Probiotic Therapy on the Endocannabinoid System, Pain, Sleep and Fatigue: A Randomized, Double-Blind, Placebo-Controlled Trial in Dancers. Int J Mol Sci. 2024 May 21;25(11):5611. doi: 10.3390/ijms25115611. |
| FG001 | Placebo Group (PLA) | Final sample: 11 participants (out of ~30 originally planned). Starch (placebo): 3-month placebo supplementation (one capsule daily). Note: Some participants were excluded due to early withdrawal or failure to complete the protocol. |
| COMPLETED |
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| NOT COMPLETED |
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Randomization resulted in unequal group sizes due to participant withdrawal after allocation and scheduling constraints that prevented completion of baseline testing for several individuals. Consequently, baseline assessments were completed by 20 participants who met all inclusion criteria and provided valid baseline data used in demographic summaries.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Probiotic Treatment Group (PRO) | Daily supplementation with a probiotic capsule containing Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 (Sanprobi Stress), taken once daily for 12 weeks. |
| BG001 | Placebo Group (PLA) | Daily supplementation with a placebo capsule containing starch, identical in appearance to the probiotic capsule, taken once daily for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | All participants were female | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Only female dance students from the University of Physical Education in Poznań were able to meet the study requirements, as they managed to make time for the research procedures despite their demanding schedules. Recruitment efforts outside the university, including private dance schools and public theaters, were unsuccessful due to professional obligations or reluctance to undergo repeated blood and stool sampling and comply with the strict study protocol. | Number | participants |
| |||||||||||||||
| Body weight | Mean | Standard Deviation | kilograms |
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| Body fat % | Mean | Standard Deviation | Body mass percentage |
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| Physical activity level | Mean | Standard Deviation | Hours per week |
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| Handgrip strength | Mean | Standard Deviation | kilograms |
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| Energy intake | Mean | Standard Deviation | kilocalories |
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| Mediterranean diet adherence score | The Mediterranean Diet Adherence Score was assessed using the 14-item Mediterranean Diet Assessment Tool (MDAT). The questionnaire evaluates adherence to the Mediterranean dietary pattern, emphasizing vegetables, fruits, legumes, whole grains, fish, and olive oil, while limiting processed foods, added sugars, and trans fats. Each item is scored 0 or 1 depending on adherence, resulting in a total score ranging from 0 to 14, with higher scores indicating better adherence. | Mean | Standard Deviation | units on a scale |
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| White blood cells | Mean | Standard Deviation | cells x10^9/L |
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| Lymphocytes | Mean | Standard Deviation | cells x10^9/L |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Qualitative Assessment of Intestinal Microbiota in Stool Samples | • gut bacteria species in stool will be assessed using the shallow shotgun sequencing method, NGS (Next-Generation Sequencing); | Stool samples were collected at baseline and post-intervention according to the study protocol; however, the planned sequencing and metagenomic analyses were not performed due to lack of funding and laboratory resources. Consequently, no outcome data were generated for this Outcome Measure, no participants were analyzed (0 in each arm), and no statistical analyses were performed. No future analyses are planned for this Outcome Measure. | Posted | Baseline and 3 months |
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| Primary | Quantitive Change in Intestinal Microbiota in Stool Samples | • determination of quantitative (Colony forming units - CFU) changes in bacteria in the stool - the shallow shotgun sequencing method, NGS (Next Generation Sequencing) molecular analysis will be used to assess the changes; | Stool samples were collected at baseline and at 3 months according to the study protocol. However, due to lack of funding and laboratory resources, the planned next-generation sequencing and metagenomic analyses were not performed, and no quantitative microbiota data were generated. Consequently, no participants were analyzed for this Outcome Measure (0 in each arm), no statistical analyses were conducted, and no future analyses are planned for this Outcome Measure. | Posted | Baseline and 3 months |
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| Primary | Intestinal Metabolome in Stool Samples | Metabolites with fold change >1.5 and p<0.05 were considered significantly altered. The reported values represent the number of metabolites meeting these criteria in the probiotic group. • metabolomic analysis (non-targeted metabolome, short-chain fatty acids, trimethylamines, tryptophan catabolites) will be performed on a quadrupole mass spectrometer coupled with a time-of-flight (QToF) analyzer connected to the high performance liquid chromatograph (UHPLC). | Stool samples were collected according to the study protocol. Due to financial and laboratory resource limitations, metabolomic analyses were performed only for participants in the probiotic treatment group, and no metabolomic data were generated for the placebo group. Consequently, participants in the probiotic group with available metabolomic data were analyzed for this Outcome Measure. No additional metabolomic analyses are planned for PLA group for this Outcome Measure. | Posted | Number | metabolites | Baseline and 3 months |
| |||||||||||||||||||||
| Primary | Quantitive Change in Endocannabinoids Levels in Blood Samples | • determination of endocannabinoids and cannabinoid receptors: anandamide (AEA) using ELISA Kit (nanograms per millilitre (ng/mL)); | One participant was excluded from the analysis due to an outlier value that affected the normality of the distribution. | Posted | Mean | Standard Deviation | ng/mL | Baseline and 3 months |
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| Primary | Quantitive Change in Endocannabinoids' Receptors Levels in Blood Samples | • determination of cannabinoid receptors: Endocannabinoid Receptor 2 (CNR2) using ELISA Kit (nanograms per millilitre (ng/mL)); | One participant was excluded from the analysis due to an outlier value that affected the normality of the distribution. | Posted | Mean | Standard Deviation | ng/mL | Baseline and 3 months |
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| Primary | Quantitive Change in Endocannabinoids Metabolism Enzymes in Blood | • determination of cannabinoid metabolism enzymes: fatty acid amide hydrolase (FAAH) using ELISA Kit (nanograms per millilitre (ng/mL)); | One participant was excluded from the analysis due to an outlier value that affected the normality of the distribution. | Posted | Mean | Standard Deviation | ng/mL | Baseline and 3 months |
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| Primary | Quantitive Change in Intestinal Barrier Proteins in Blood Samples | • determination of blood biomarkers of a disturbed intestinal barrier concentrations: zonulin, calprotectin (CALPRO) using ELISA Kit (nanograms per millilitre (ng/mL)); | Blood samples were collected at baseline and at 3 months according to the study protocol. However, due to lack of funding and laboratory resources, ELISA-based quantification of intestinal barrier biomarkers (zonulin and calprotectin) was not performed, and no outcome data were generated. Consequently, no participants were analyzed for this Outcome Measure (0 in each arm), no statistical analyses were conducted, and no future analyses are planned for this Outcome Measure. | Posted | Baseline and 3 months |
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| Primary | Quantitive Change in Intestinal Barrier Biomarkers in Blood Samples | • determination of blood biomarkers of a disturbed intestinal barrier concentrations: lipopolysaccharide (LPS), using ELISA Kit (picograms per millilitre (pg/mL)); | One participant was excluded from the analysis due to an outlier value that affected the normality of the distribution. | Posted | Mean | Standard Deviation | pg/mL | Baseline and 3 months |
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| Primary | Quantitive Change in Tumor Necrosis Factor-alpha (TNF-α) in Blood Samples | • determination of blood tumor necrosis factor-alpha (TNF-α) concentration using ELISA Kit (nanograms per millilitre (ng/mL)); | One participant was excluded from the analysis due to an outlier value that affected the normality of the distribution. | Posted | Mean | Standard Deviation | pg/mL | Baseline and 3 months |
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| Primary | Quantitive Change in Leukemia Inhibitory Factor (LIF) in Blood Samples | • determination of blood leukemia inhibitory factor (LIF) concentration using ELISA Kit (nanograms per millilitre (ng/mL)); | Blood samples were collected at baseline and at 3 months according to the study protocol. However, due to lack of funding and laboratory resources, ELISA-based quantification of leukemia inhibitory factor (LIF) was not performed, and no outcome data were generated. Consequently, no participants were analyzed for this Outcome Measure (0 in each arm), no statistical analyses were conducted, and no future analyses are planned for this Outcome Measure. | Posted | Baseline and 3 months |
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| Primary | Quantitive Change in Blood Interleukins Profile | • determination of interleukins concentrations: IL-1β (interleukin-1beta), using ELISA Kit (picograms per millilitre (pg/mL)); | One participant was excluded from the analysis due to an outlier value that affected the normality of the distribution. | Posted | Mean | Standard Deviation | pg/mL | Baseline and 3 months |
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| Primary | Quantitive Change in Chronic Stress Biomarker in Blood Samples - Cortisol | • determination of blood cortisol concentration using ELISA Kit (nanograms per millilitre (ng/mL)) - Instead of cortisol, IL-10 levels were analyzed as a marker of anti-inflammatory response [pg/mL]. | One participant was excluded from the analysis due to an outlier value that affected the normality of the distribution. | Posted | Mean | Standard Deviation | pg/mL | Baseline and 3 months |
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| Primary | Quantitive Change in Inflammation Biomarker in Blood Samples - C-reactive Protein | • determination of C-reactive protein (CRP) concentration using ELISA Kit (picograms per millilitre (pg/mL)); | Blood samples were collected at baseline and after the intervention from participants who met all inclusion criteria. However, c-reactive protein levels were not quantified, and no analyzable outcome data were generated for this measure due to budgetary constraints and limited time frame. Consequently, no participants were analyzed for this outcome (0 in each arm), no statistical analyses were conducted, and no future analyses are planned. | Posted | Baseline and 3 months |
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| Secondary | Coping With Stress Questionnaire | • determination of methods of active coping with stress using the Inventory for Measuring Coping with Stress (Mini-COPE); It is designed to establish how a study participant behaves when experiences particular events; The scale: 0 = "I hardly ever do this", 1 = "I rarely do this", 2 = "I do this often", 3 = "I almost always do this"; [0-18] - higher scores mean better outcome | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 months |
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| Secondary | Fatigue Questionnaire | • assessment of the level of fatigue using the Fatigue Assessment Scale (FAS); the statements of the questionnaire relate to the feeling of well-being; The scale: 1. Never (0 points), 2. Sometimes (once a month or less) (1 point), 3. Regularly (several times a month) (2 points), 4. Often (weekly)(3 points) and 5. Always (everyday) (4 points); [0-32] - higher score means worse outcome | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 months |
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| Secondary | Gastrointestinal Disorders Questionnaire | • assessment of gastrointestinal pain using the Rome IV Questionnaire for adults (selected questions on irritable bowel syndrome, constipation and diarrhea); the statements of the questionnaire relate to frequency and intensity of disorders; [0-10] - higher scores mean worse outcome; | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 months |
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| Secondary | Sleep Quality Questionnaire | • assessment of the sleep quality level using Pittsburgh Sleep Quality Questionnaire (PSQI); the statements of the questionnaire relate to frequency of sleep disorders; [0-3] - higher scores mean worse outcome; | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 months |
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| Secondary | Body Mass Analysis (BMI, kg/m^2) | • determination of body weight and composition using the electrical bioimpedance method; | Participants reported maintaining their habitual diet composition and physical activity throughout the study period, therefore, meaningful changes in BMI were not expected. Within the limited project budget and time frame, BMI was not prioritized for results reporting, BMI change was not derived or tabulated, and no analytical dataset was generated for this outcome. 0 participants were analyzed (0 in each arm), no statistical analyses were conducted, and no future analyses are planned. | Posted | Baseline and 3 months |
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| Secondary | Body Composition Analysis (Percent of Total Body Mass) | • assessment of bone, fat and fat-free mass using the electrical bioimpedance method; | Body composition measurements (fat mass, fat-free mass as percent of total body mass) were collected according to the study protocol, with participants instructed to maintain their habitual diet and lifestyle. However, outcome data for the prespecified body composition change were not derived or tabulated, and no dataset was generated (limited project budget and time frame). Therefore, no participants were analyzed, no statistical analyses were conducted, and no future analyses are planned. | Posted | Baseline and 3 months |
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| Secondary | Composite Measure of Diet Composition Assessed by Food Diaries | • assessment of protein, fat, carbohydrates and fibre intake using food diaries (grams); | Dietary composition was assessed at baseline using food diaries. Participants were instructed to maintain their habitual diet and lifestyle throughout the study period. However, changes in dietary composition over time were not statistically analyzed, and no longitudinal outcome dataset was generated (limited project budget and time frame). Therefore, no participants were analyzed for this outcome (0 in each arm), no statistical analyses were conducted, and no future analyses are planned. | Posted | Baseline and 3 months |
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| Secondary | Pain Threshold Test (Newtons) | • mechanical stimuli pain threshold assessment using an algometer. Mechanical pressure pain threshold was assessed on the thumb flexor muscle using a pressure algometer. The probe was applied perpendicularly with gradually increasing pressure until the participant indicated the first painful sensation. Three consecutive measurements were performed, and the mean value in Newtons was recorded as the outcome. | Posted | Mean | Standard Deviation | Newtons | Baseline and 3 months |
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| Secondary | Changes in Red Blood Cells Count | • determination of red blood cell counts using flow cytometry (trillion cells per Litre); | Blood samples were collected at baseline and after the intervention from participants who met all inclusion criteria. However, red blood cell counts were not quantified, and no analyzable outcome data were generated for this measure due to budgetary constraints. Consequently, no participants were analyzed for this outcome (0 in each arm), no statistical analyses were conducted, and no future analyses are planned. | Posted | Baseline and 3 months |
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| Secondary | Changes in White Blood Cells Count | • determination of white blood cells counts using flow cytometry (billion cells per Litre); | Blood samples were collected at baseline and after the intervention from participants who met all inclusion criteria. However, changes in white blood cell counts were not measured, and no analyzable outcome data were generated for this measure due to budgetary constraints. Consequently, no participants were analyzed for this outcome (0 in each arm), no statistical analyses were conducted, and no future analyses are planned. | Posted | Baseline and 3 months |
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| Secondary | Changes in Hemoglobin Level | • determination of hemoglobin level using flow cytometry (grams per Litre); | Blood samples were collected at baseline and after the intervention from participants who met all inclusion criteria. However, hemoglobin levels were not quantified, and no analyzable outcome data were generated for this measure due to budgetary constraints. Consequently, no participants were analyzed for this outcome (0 in each arm), no statistical analyses were conducted, and no future analyses are planned. | Posted | Baseline and 3 months |
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| Secondary | Changes in Hematocrit | • determination of hematocrit using flow cytometry (percentage of red blood cells in blood); | Blood samples were collected at baseline and after the intervention from participants who met all inclusion criteria. However, hematocrit levels were not quantified, and no analyzable outcome data were generated for this measure due to budgetary constraints. Consequently, no participants were analyzed for this outcome (0 in each arm), no statistical analyses were conducted, and no future analyses are planned. | Posted | Baseline and 3 months |
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| Secondary | Changes in Platelets Counts | • determination of platelets counts using flow cytometry (billions per Litre) | Blood samples were collected at baseline and after the intervention from participants who met all inclusion criteria. However, platelet counts were not quantified, and no analyzable outcome data were generated for this measure due to budgetary constraints. Consequently, no participants were analyzed for this outcome (0 in each arm), no statistical analyses were conducted, and no future analyses are planned. | Posted | Baseline and 3 months |
|
|
6 months
All participants completed the intervention without reporting adverse effects.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Probiotic Treatment Group (PRO) | All participants completed the intervention without reporting adverse effects. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG001 | Placebo Group (PLA) | All participants completed the intervention without reporting adverse effects. | 0 | 12 | 0 | 12 | 0 | 12 |
Not provided
Not provided
The small, all-female sample of professional dancers limits generalizability and statistical power. Baseline differences in key biomarkers, short intervention duration, and lack of follow-up restrict interpretation. No dose-response or synbiotic arms were included. ELISA-based measurements may lack precision compared to LC-MS. Gut microbiome sequencing and plasma metabolite analysis were not performed, limiting mechanistic insight.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jakub Wiącek | Poznan University of Physical Education | +48697881422 | wiacek@awf.poznan.pl |
| Sep 7, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 28, 2025 | Sep 7, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D005221 | Fatigue |
| D000073397 | Occupational Stress |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009784 | Occupational Diseases |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D013213 | Starch |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |
Not provided
Not provided
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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