Effects of Probiotics on Gut Microbiota, Endocannabinoid and Immune Activation and Symptoms of Fatigue in Dancers

NCT05567653 | Completed Results

• 1 other identifier: 11/NSN/4/2022
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fatigue; Stress, Job

Keywords

Gut microbiome; Probiotics; Professional dancers; Cannabinoids; Inflammation

Outcome Measures

Primary Outcomes (13)

• 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

  • 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

Secondary Outcomes (13)

• Coping With Stress Questionnaire

  Baseline and 3 months

• Fatigue Questionnaire

  Baseline and 3 months

• Gastrointestinal Disorders Questionnaire

  Baseline and 3 months

• Sleep Quality Questionnaire

  Baseline and 3 months

• Body Mass Analysis (BMI, kg/m^2)

  Baseline and 3 months

Study Arms (2)

Probiotic treatment group

EXPERIMENTAL

ca. 30 participants

Dietary Supplement: Lactobacillus helveticus Rosell-52 and Bifidobacterium longum Rosell-175 (Sanprobi Stress)

Placebo group

PLACEBO COMPARATOR

ca. 30 participants

Dietary Supplement: Starch (placebo)

Interventions

Starch (placebo) DIETARY_SUPPLEMENT

3-month placebo

Also known as: capsules containing starch

Placebo group

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)

Also known as: L. helveticus R-0052, B. longum R-0175

Probiotic treatment group

Eligibility Criteria

• Age: 18 Years - 36 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age \> 18, \<36 years old;
• Professional dancing activity with over 8 hours of training per week.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poznan University of Physical Education: lead

Study Sites (1)

Poznan University of Physical Education

Poznan, 61-871, Poland

Location

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MeSH Terms

Conditions

Fatigue; Occupational Stress; Inflammation

Interventions

Starch

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Occupational Diseases; Stress, Psychological; Behavioral Symptoms; Behavior; Pathologic Processes

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Limitations and Caveats

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.

Results Point of Contact

• Title: Jakub Wiącek
• Organization: Poznan University of Physical Education

wiacek@awf.poznan.pl

+48697881422

Study Officials

• Joanna Karolkiewicz, Professor

  Poznan University of Physical Education

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: a Randomized, Double-blind, Placebo-controlled Study

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: October 5, 2022
• Study Start: October 1, 2022
• Primary Completion: March 8, 2023
• Study Completion: June 13, 2023
• Last Updated: February 20, 2026
• Results First Posted: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)