Lactobacillus helveticus Rosell-52 and Bifidobacterium longum Rosell-175 (Sanprobi Stress)
3-month, multi-strain probiotic supplementation (one a day, 3 x 10⁹ CFU)
L. helveticus R-0052, B. longum R-0175Loading study record…
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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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-02-20
What this record can show
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Registry facts
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.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Research network
Interventions
3-month, multi-strain probiotic supplementation (one a day, 3 x 10⁹ CFU)
L. helveticus R-0052, B. longum R-01753-month placebo
capsules containing starchSource-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
• gut bacteria species in stool will be assessed using the shallow shotgun sequencing method, NGS (Next-Generation Sequencing);
Population: 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.
• 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;
Population: 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.
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).
Population: 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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Probiotic Treatment Group (PRO) | 5 | 16 | - |
• determination of endocannabinoids and cannabinoid receptors: anandamide (AEA) using ELISA Kit (nanograms per millilitre (ng/mL));
Population: One participant was excluded from the analysis due to an outlier value that affected the normality of the distribution.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Probiotic Treatment Group (PRO) | 5 | -1.11 | 35.90 |
| Placebo Group (PLA) | 10 | 14.08 | 56.63 |
• determination of cannabinoid receptors: Endocannabinoid Receptor 2 (CNR2) using ELISA Kit (nanograms per millilitre (ng/mL));
Population: One participant was excluded from the analysis due to an outlier value that affected the normality of the distribution.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Probiotic Treatment Group (PRO) | 5 | -0.26 | 0.29 |
| Placebo Group (PLA) | 10 | -0.14 | 0.57 |
• determination of cannabinoid metabolism enzymes: fatty acid amide hydrolase (FAAH) using ELISA Kit (nanograms per millilitre (ng/mL));
Population: One participant was excluded from the analysis due to an outlier value that affected the normality of the distribution.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Probiotic Treatment Group (PRO) | 5 | 0.09 | 0.71 |
| Placebo Group (PLA) | 10 | 0.48 | 1.11 |
• determination of blood biomarkers of a disturbed intestinal barrier concentrations: zonulin, calprotectin (CALPRO) using ELISA Kit (nanograms per millilitre (ng/mL));
Population: 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.
• determination of blood biomarkers of a disturbed intestinal barrier concentrations: lipopolysaccharide (LPS), using ELISA Kit (picograms per millilitre (pg/mL));
Population: One participant was excluded from the analysis due to an outlier value that affected the normality of the distribution.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Probiotic Treatment Group (PRO) | 5 | 3.48 | 81.67 |
| Placebo Group (PLA) | 10 | 56.98 | 82.96 |
• determination of blood tumor necrosis factor-alpha (TNF-α) concentration using ELISA Kit (nanograms per millilitre (ng/mL));
Population: One participant was excluded from the analysis due to an outlier value that affected the normality of the distribution.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Probiotic Treatment Group (PRO) | 5 | 10.28 | 10.89 |
| Placebo Group (PLA) | 10 | 7.15 | 16.79 |
• determination of blood leukemia inhibitory factor (LIF) concentration using ELISA Kit (nanograms per millilitre (ng/mL));
Population: 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.
• determination of interleukins concentrations: IL-1β (interleukin-1beta), using ELISA Kit (picograms per millilitre (pg/mL));
Population: One participant was excluded from the analysis due to an outlier value that affected the normality of the distribution.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Probiotic Treatment Group (PRO) | 5 | 46.52 | 164.81 |
| Placebo Group (PLA) | 10 | 104.61 | 164.60 |
• 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 \[pg/mL\].
Population: One participant was excluded from the analysis due to an outlier value that affected the normality of the distribution.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Probiotic Treatment Group (PRO) | 5 | 66.17 | 92.87 |
| Placebo Group (PLA) | 10 | 24.95 | 62.83 |
• determination of C-reactive protein (CRP) concentration using ELISA Kit (picograms per millilitre (pg/mL));
Population: 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.
• 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
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Probiotic Treatment Group (PRO) | 5 | -1 | 2.1 |
| Placebo Group (PLA) | 10 | -0.8 | 3.2 |
• 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
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Probiotic Treatment Group (PRO) | 5 | -6.2 | 4.92 |
| Placebo Group (PLA) | 10 | -2.8 | 5.51 |
• 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;
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Probiotic Treatment Group (PRO) | 5 | -0.2 | 0.75 |
| Placebo Group (PLA) | 11 | -0.55 | 0.99 |
• 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;
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Probiotic Treatment Group (PRO) | 5 | -0.4 | 0.8 |
| Placebo Group (PLA) | 10 | 0.48 | 0.66 |
• determination of body weight and composition using the electrical bioimpedance method;
Population: 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.
• assessment of bone, fat and fat-free mass using the electrical bioimpedance method;
Population: 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.
• assessment of protein, fat, carbohydrates and fibre intake using food diaries (grams);
Population: 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.
• 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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Probiotic Treatment Group (PRO) | 5 | -0.93 | 5.12 |
| Placebo Group (PLA) | 10 | -3.9 | 10.20 |
• determination of red blood cell counts using flow cytometry (trillion cells per Litre);
Population: 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.
• determination of white blood cells counts using flow cytometry (billion cells per Litre);
Population: 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.
• determination of hemoglobin level using flow cytometry (grams per Litre);
Population: 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.
• determination of hematocrit using flow cytometry (percentage of red blood cells in blood);
Population: 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.
• determination of platelets counts using flow cytometry (billions per Litre)
Population: 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.
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.
| Milestone | Probiotic Treatment Group (PRO) | Placebo Group (PLA) |
|---|---|---|
| STARTED | 8 | 12 |
| COMPLETED | 6 | 11 |
| NOT COMPLETED | 2 | 1 |
Eligibility
primary outcomes
Time frame: Baseline and 3 months
• gut bacteria species in stool will be assessed using the shallow shotgun sequencing method, NGS (Next-Generation Sequencing);
Time frame: Baseline and 3 months
• 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;
Time frame: Baseline and 3 months
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).
Time frame: Baseline and 3 months
• determination of endocannabinoids and cannabinoid receptors: anandamide (AEA) using ELISA Kit (nanograms per millilitre (ng/mL));
Time frame: Baseline and 3 months
• determination of cannabinoid receptors: Endocannabinoid Receptor 2 (CNR2) using ELISA Kit (nanograms per millilitre (ng/mL));
Time frame: Baseline and 3 months
• determination of cannabinoid metabolism enzymes: fatty acid amide hydrolase (FAAH) using ELISA Kit (nanograms per millilitre (ng/mL));
Time frame: Baseline and 3 months
• determination of blood biomarkers of a disturbed intestinal barrier concentrations: zonulin, calprotectin (CALPRO) using ELISA Kit (nanograms per millilitre (ng/mL));
Time frame: Baseline and 3 months
• determination of blood biomarkers of a disturbed intestinal barrier concentrations: lipopolysaccharide (LPS), using ELISA Kit (picograms per millilitre (pg/mL));
Time frame: Baseline and 3 months
• determination of blood tumor necrosis factor-alpha (TNF-α) concentration using ELISA Kit (nanograms per millilitre (ng/mL));
Time frame: Baseline and 3 months
• determination of blood leukemia inhibitory factor (LIF) concentration using ELISA Kit (nanograms per millilitre (ng/mL));
Time frame: Baseline and 3 months
• determination of interleukins concentrations: IL-1β (interleukin-1beta), using ELISA Kit (picograms per millilitre (pg/mL));
Time frame: Baseline and 3 months
• 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 \[pg/mL\].
Time frame: Baseline and 3 months
• determination of C-reactive protein (CRP) concentration using ELISA Kit (picograms per millilitre (pg/mL));
secondary outcomes
Time frame: Baseline and 3 months
• 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
Time frame: Baseline and 3 months
• 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
Time frame: Baseline and 3 months
• 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;
Time frame: Baseline and 3 months
• 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;
Time frame: Baseline and 3 months
• determination of body weight and composition using the electrical bioimpedance method;
Time frame: Baseline and 3 months
• assessment of bone, fat and fat-free mass using the electrical bioimpedance method;
Time frame: Baseline and 3 months
• assessment of protein, fat, carbohydrates and fibre intake using food diaries (grams);
Time frame: Baseline and 3 months
• 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.
Time frame: Baseline and 3 months
• determination of red blood cell counts using flow cytometry (trillion cells per Litre);
Time frame: Baseline and 3 months
• determination of white blood cells counts using flow cytometry (billion cells per Litre);
Time frame: Baseline and 3 months
• determination of hemoglobin level using flow cytometry (grams per Litre);
Time frame: Baseline and 3 months
• determination of hematocrit using flow cytometry (percentage of red blood cells in blood);
Time frame: Baseline and 3 months
• determination of platelets counts using flow cytometry (billions per Litre)
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