N/A
Completed N=20
Effects of Probiotics on Gut Microbiota, Endocannabinoid and Immune Activation and Symptoms of Fatigue in Dancers
Fatigue · Stress, Job
Source: ClinicalTrials.gov NCT05567653 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcomePrimary: Qualitative Assessment of Intestinal Microbiota in Stool Samples
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Qualitative Assessment of Intestinal Microbiota in Stool Samples |
— | — |
| PRIMARY Quantitive Change in Intestinal Microbiota in Stool Samples |
— | — |
| PRIMARY Intestinal Metabolome in Stool Samples |
16 | — |
| PRIMARY Quantitive Change in Endocannabinoids Levels in Blood Samples |
-1.11; 14.08 | — |
| PRIMARY Quantitive Change in Endocannabinoids' Receptors Levels in Blood Samples |
-0.26; -0.14 | — |
| PRIMARY Quantitive Change in Endocannabinoids Metabolism Enzymes in Blood |
0.09; 0.48 | — |
| PRIMARY Quantitive Change in Intestinal Barrier Proteins in Blood Samples |
— | — |
| PRIMARY Quantitive Change in Intestinal Barrier Biomarkers in Blood Samples |
3.48; 56.98 | — |
| PRIMARY Quantitive Change in Tumor Necrosis Factor-alpha (TNF-α) in Blood Samples |
10.28; 7.15 | — |
| PRIMARY Quantitive Change in Leukemia Inhibitory Factor (LIF) in Blood Samples |
— | — |
| PRIMARY Quantitive Change in Blood Interleukins Profile |
46.52; 104.61 | — |
| PRIMARY Quantitive Change in Chronic Stress Biomarker in Blood Samples - Cortisol |
66.17; 24.95 | — |
| PRIMARY Quantitive Change in Inflammation Biomarker in Blood Samples - C-reactive Protein |
— | — |
| SECONDARY Coping With Stress Questionnaire |
-1; -0.8 | — |
| SECONDARY Fatigue Questionnaire |
-6.2; -2.8 | — |
| SECONDARY Gastrointestinal Disorders Questionnaire |
-0.2; -0.55 | — |
| SECONDARY Sleep Quality Questionnaire |
-0.4; 0.48 | — |
| SECONDARY Body Mass Analysis (BMI, kg/m^2) |
— | — |
| SECONDARY Body Composition Analysis (Percent of Total Body Mass) |
— | — |
| SECONDARY Composite Measure of Diet Composition Assessed by Food Diaries |
— | — |
| SECONDARY Pain Threshold Test (Newtons) |
-0.93; -3.9 | — |
| SECONDARY Changes in Red Blood Cells Count |
— | — |
| SECONDARY Changes in White Blood Cells Count |
— | — |
| SECONDARY Changes in Hemoglobin Level |
— | — |
| SECONDARY Changes in Hematocrit |
— | — |
| SECONDARY Changes in Platelets Counts |
— | — |
Eligibility Criteria
Inclusion Criteria
- Age > 18, 36 y.o.;
- Being injured within 3 months from the start of the study;
- Taking pre- and / or probiotics in the last 3 months before the study;
- Hospitalization during the last 4 weeks before starting of the study;
- Traveling to tropical countries during the last 4 weeks before study;
- Taking antibiotics, steroids and anabolic steroids in the last 4 weeks before study.
Data sourced from ClinicalTrials.gov (NCT05567653). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.