Sports NutritionPhase 2/3NCT07252778
Effect of a Short-term Multi-strain Probiotic Supplementation in Endurance Athletes
A Phase 2/3 study testing MPRO supplementation in people with Sports Nutrition and Biochemical Markers, run by Krzysztof Durkalec-Michalski at 1 site in Poland.
Trial summary
The aim of this project is to evaluate and identify the effect of a short-term 2-week multi-strain probiotic (MPRO) supplementation on the exercise-associated gastrointestinal (GI) symptoms and perturbations in high level female athletes of the Polish national team during strictly controlled conditions of a training… Read more about this study
- Who is it for?
- Ages 16 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sports Nutrition, Biochemical Markers, Exercise Performance
- What is being tested?
- MPRO supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 20 Nov 2025to 30 Jun 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- belonging to the national rowing team;
- training experience ≥5 years;
- a currently issued medical certificate confirming
- good health and capacity to practice sports;
- good health without chronic health disorders;
- written informed consent to participate.
Who cannot join
- injury, any health contraindication or failure to perform exercise procedures;
- gastrointestinal infections, diseases, disorders;
- past history of gastrointestinal surgery, and
- other self-reported gastrointestinal issues;
- reporting symptoms of infection or taking any medication (e.g. antibiotics) for 4 weeks before the study protocol;
- current supplementation of prebiotics,
Show all 11Show fewer
- probiotics, synbiotics (last 4 weeks);
- current intake of pharmaceutical agents (e.g., nonsteroidal anti-inflammatory drugs, laxatives, antidiarrhea agents, antacids, and/or antiemetics) (last 4 weeks);
- failure to follow the study protocol;
- declared general feeling of being unwell;
- pregnancy or current pregnancy planning.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Krzysztof Durkalec-Michalski, PhD contact
Poland1 site, 1 recruiting
- Recruiting
Department of Sports Dietetics, Poznan University of Physical Education Poznań
Poznan, Wielkopolska, 61-871
Natalia Główka, PhD, +48 691 756 944, glowka@awf.poznan.pl
Krzysztof Durkalec-Michalski, PhD, durkalec-michalski@awf.poznan.pl
About this study
Official title: Effect of a Short-term Multi-strain Probiotic Supplementation on the Exercise- Associated Gastrointestinal Disturbances in Trained Female Athletes Under Controlled Conditions During Professional Training Cycle
The aim of this project is to evaluate and identify the effect of a short-term 2-week multi-strain probiotic (MPRO) supplementation on the exercise-associated gastrointestinal (GI) symptoms and perturbations in high level female athletes of the Polish national team during strictly controlled conditions of a training camp, based on recommendations for best practices for probiotic (PRO) research in athletes and assessment of EX-associated GI perturbations.
Read the detailed description
Objective of the study: GI health is crucial for the maintenance of general health and high performance in athletes. It is well known that GI symptoms are common in endurance athletes and that women are more likely to experience moderate or severe levels of symptoms. Exercise stress and external factors have an impact on GI health, leading to perturbations of GI integrity and functions negatively affecting performance outcomes. It is therefore necessary to develop treatment strategies capable of strengthening the GI health. Among the various preparations, PRO seem to induce improvements in intestinal diseases. There is a possible direct association between the reduced exercise-induced perturbations and cytokines, gut barrier function, and GI symptoms after PRO supplementation, but it has not been fully clarified yet. Moreover, it is stated that PRO benefits are strain-specific and dose-dependent, and include improved gut-barrier function, nutrient absorption, recovery and performance in athletes. Nevertheless, there is lack of well-designed studies on athletes population. Therefore, the main goal of the project is to evaluate and identify the effect of a short-term 2-week MPRO supplementation on the exercise- associated GI symptoms and perturbations in high level female rowers (particularly exposed to GI disturbances) of the Polish national team during completely controlled conditions of a training camp, based on recommendations for best practices for probiotic research in athletes and assessment of exercise-associated GI perturbations. The primary outcome is to recognize the MPRO supplementation effect on GI mechanisms, responsible for the occurrence of exercise-induced GI symptoms negatively affecting exercise performance. The following research hypotheses were adopted: A) considerable physical stress induced by high intensity exercises during national training camp contribute to the occurrence of GI disturbances; B) MPRO during high intensity training schedule may have a significant impact on specific key markers of GI perturbations; C) MPRO may have a positive effect on GI integrity; D) MPRO may have a beneficial effect on the systemic immune responses; E) MPRO may alter the fecal bacterial composition; F) MPRO may positively affect psychological stress and mood during high intensity training camp; G) MPRO may positively affect exercise performance outcomes.
Research project methodology: The study will be conducted in the standard of randomized, triple-blind, PLA-controlled crossover studies. A number of 30 high level female rowers will be enrolled. Specific MPRO strategy will be implemented. The assessment of body composition, exercise performance, baseline stool and baseline/post-exercise blood collection, GI and stress and mood status and nutrition will be performed. Samples will be analysed for: A) GI integrity markers permeability, bacterial endotoxin translocation, B) immune/stress responses' markers [inflammatory cytokine profile, immune cell response, C) exercise adaptation and intensity markers, D) stool GI integrity markers, E) fecal bacterial composition.
Expected impact of the research project on the development of science, practice and society: This completely innovative MPRO project will be conducted according to recently released recommendations for best practices for probiotic research in athletes and assessment of exercise-associated GI perturbations. Furthermore, recognizing the impact of MPRO on GI health could have beneficial implications for athletes, and people from the general population. An indisputable strength of our project is the fact that obtained data may be extrapolated into a real-world. Information on whether MPRO administration promotes proper GI health and physical training adaptation could be important for developing recommendations for PRO usage. Finally, the indisputable necessity of conducting research in the area of PRO is proved, in particular, by the abundance of GI disturbances, in terms of investigating natural methods in the prevention of GI symptoms.
- Conditions
- Sports Nutrition, Biochemical Markers, Exercise Performance, Aerobic Capacity, Supplementation
- Being tested
- MPRO supplementation, Placebo treatment
- Keywords
- Probiotics, Gastro-intestinal markers, Microbiota, Rowing, Females
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPRO supplementationDietary supplement
In the experimental procedure each athlete will be supplemented with a certificated, commercially available MPRO supplement SANPROBI® Barrier (Bifidobacterium lactis W52, Lactobacillus brevis W63, Lactobacillus casei W56, Lactococcus lactis W19, Lactococcus lactis W58, Lactobacillus acidophilus W37, Bifidobacterium bifidum W23, Bifidobacterium lactis W51, Lactobacillus salivarius W24).
The supplement will be provided in the capsule form and will be taken twice a day [4 capsules of MPRO/day (2×10to9 CFU/g, 500 milions CFU/capsule) in two servings/day (2x2 capsules].
Placebo treatmentDietary supplement
In the control procedure each athlete will be supplemented with a placebo (PLA). The PLA group will receive corn starch mixed with maltodextrins. The PLA will be provided in the capsule form and will be taken twice a day (2x2 capsules/day).
| Study group | Role | What they receive |
|---|---|---|
| MPRO supplementation | Experimental | The experimental procedure for each participant in this group will include a 2-week period of MPRO supplementation.
The entire study protocol will include familiarization and 4 main study visits (T1-T4; before/after supplementation). Enrolled volunteers will be randomly assigned to the treatment order with specific codes by an impartial biostatistician. Each study visit will consist of anthropometric indices and body composition evaluation, three saliva and blood samplings (resting; 3 min and 60 min after exercise) and exercise performance evaluation. Additionally, all participants will donate their stool samples into specially prepared two empty tubes. Samples will be collected on the same days as saliva/blood samples, early in the morning. Moreover, during each study visit, participants will complete a specific, validated GI symptoms questionnaire and specific and validated stress and mood questionnaires to assess their stress and mood before and after MPRO supplementation. Receives: Dietary Supplement: MPRO supplementation |
| PLA treatment | Placebo comparator | The experimental procedure for each participant in this group will include a 2-week period of placebo supplementation.
The entire study protocol will include familiarization and 4 main study visits (T1-T4; before/after supplementation). Enrolled volunteers will be randomly assigned to the treatment order with specific codes by an impartial biostatistician. Each study visit will consist of anthropometric indices and body composition evaluation, three saliva and blood samplings (resting; 3 min and 60 min after exercise) and exercise performance evaluation. Additionally, all participants will donate their stool samples into specially prepared two empty tubes. Samples will be collected on the same days as saliva/blood samples, early in the morning. Moreover, during each study visit, participants will complete a specific, validated GI symptoms questionnaire and specific and validated stress and mood questionnaires to assess their stress and mood before and after placebo supplementation. Receives: Dietary Supplement: Placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gastrointestinal integrity and inflammation markers (I-FABP, claudin-3, zonulin, LPS, scd-14, LBP, ocludin, lipocalin-2, DAO) (ng/mL) in blood after MPRO supplementation and PLA treatment
Assessment of the gastrointestinal integrity markers (I-FABP, claudin-3, zonulin, LPS, scd-14, LBP, ocludin, lipocalin-2, DAO) (ng/mL) in blood at three time-points (resting [REST]; 3 min [POST-EX] and 60 min after completion of the test exercise [REC]) will be carried out at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA).
Measured: Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.
Changes in gastrointestinal integrity and inflammation markers (zonulin, ocludin, lipocalin-2) (ng/mL) in stool after MPRO supplementation and PLA treatment
Assessment of the gastrointestinal integrity markers (zonulin, ocludin, lipocalin-2) (ng/mL) in stool at rest will be carried out at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA).
Measured: Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.
Changes in gastrointestinal integrity and inflammation markers (calprotectin, lactoferrin) (μg/g) in stool after MPRO supplementation and PLA treatment
Assessment of the gastrointestinal integrity markers (calprotectin, lactoferrin) (μg/g) in stool at rest will be carried out at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA).
Measured: Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.
Changes in gastrointestinal integrity and inflammation markers (α-1 antitripsin) (mg/g) in stool after MPRO supplementation and PLA treatment
Assessment of the gastrointestinal integrity markers (α-1 antitripsin) (mg/g) in stool at rest will be carried out at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA).
Measured: Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.
Changes in gut microbiota phylogenetic diversity (Faith's phylogenetic diversity index) after MPRO supplementation and PLA treatment
Assessment of phylogenetic α-diversity of the gut microbiome assessed from stool 16S rRNA gene sequencing; computed as Faith's Phylogenetic Diversity (sum of branch lengths on the phylogenetic tree corresponding to observed taxa) at rest will be carried out at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA).
Measured: Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.
Changes in gut microbiota species diversity (Shannon diversity index) after MPRO supplementation and PLA treatment
Assessment of species (taxonomic) α-diversity of the gut microbiome assessed from stool 16S rRNA gene sequencing; computed using the Shannon diversity index (accounts for richness and evenness) at rest will be carried out at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA).
Measured: Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.
Changes in gut microbiota species richness (number of observed species (OTUs)) after MPRO supplementation and PLA treatment
Assessment of species richness of the gut microbiome assessed from stool 16S rRNA gene sequencing; reported as the number of observed operational taxonomic units (Observed OTUs) at rest will be carried out at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA).
Measured: Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.
Secondary outcomes (7)
Changes in blood cytokines (IL-1β/1ra/6/8/10/17, TNF-α) (pg/mL) after MPRO supplementation and PLA treatment
Assessment of the cytokines (IL-1β/1ra/6/8/10/17, TNF-α) (pg/mL) at three time-points (resting [REST]; 3 min [POST-EX] and 60 min after completion of the second test exercise [REC]) will be carried out at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA).
Measured: Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.
Changes in stress marker (cortisol) (ng/ml) in blood and saliva after MPRO supplementation and PLA treatment
Assessment of the stress marker (cortisol) (ng/ml) in blood and saliva at three time-points (resting [REST]; 3 min [POST-EX] and 60 min after completion of the test exercise [REC]) will be carried out at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA).
Measured: Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.
Changes in saliva SIgA concentration (μg/mL) after MPRO supplementation and PLA treatment
Assessment of the saliva SIgA concentration (μg/mL) at three time-points (resting [REST]; 3 min [POST-EX] and 60 min after completion of the test exercise [REC]) will be carried out at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA).
Measured: Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.
Changes in gastrointestinal symptoms incidence and severity (points) after MPRO supplementation and PLA treatment
Assessment of the gastrointestinal symptoms incidence and severity (points) will be carried out before, during and after aerobic fitness and exercise performance test at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA).
Measured: Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.
Changes in psychological stress and mood (points) after MPRO supplementation and PLA treatment
Assessment of the psychological stress and mood (points) will be carried out at rest at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA).
Measured: Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.
Changes in white blood cells count and differential (count/L) after MPRO supplementation and PLA treatment
Assessment of the leukocytes (neutrophils, monocytes, lymphocytes, neutrophils:lymphocytes ratio) (count/L) at three time-points (resting [REST]; 3 min [POST-EX] and 60 min after completion of the test exercise [REC]) will be carried out at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA).
Measured: Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.
Changes in white blood cells count and differential (%) after MPRO supplementation and PLA treatment
Assessment of the leukocytes (neutrophils, monocytes, lymphocytes, neutrophils:lymphocytes ratio) (%) at three time-points (resting [REST]; 3 min [POST-EX] and 60 min after completion of the test exercise [REC]) will be carried out at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA)
Measured: Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start20 Nov 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Krzysztof Durkalec-Michalski
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Human Genetics, Polish Academy of Sciences
- Responsible party
- Sponsor-investigator, Krzysztof Durkalec-Michalski, Poznan University of Physical Education
- Investigators
- Krzysztof Durkalec-Michalski, PhD, Study chair, Department of Sports Dietetics, Poznan University of Physical Education Poznań
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252778
- Sponsor's protocol ID
- ZDS2025_0002
- Status last verified
- Nov 2025
- First submitted
- 27 Sep 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Shared data will be exclusively related to the level of recorded indicators, without personal data. The data obtained will be attached to scientific publications, depending on the requirements of the journal. De-identified individual participant data (IPD), including timepoint-specific values of primary and secondary outcome measures (e.g., performance results, hematological and physiological parameters), will be shared. Data will be made available upon reasonable request to qualified researchers for non-commercial academic purposes, following publication of the primary results. Requests should be directed to the corresponding author via institutional email. A data use agreement may be required.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Short-term Multi-strain Probiotic Supplementation on the Exercise- Associated Gastrointestinal Disturbances in Trained Female Athletes Under Controlled Conditions During Professional Training Cycle
- ClinicalTrials.gov ID
- NCT07252778
- Acronym / sponsor ID
- ZDS2025_0002
- Conditions
- Sports Nutrition, Biochemical Markers, Exercise Performance, Aerobic Capacity, Supplementation
- Keywords
- Probiotics, Gastro-intestinal markers, Microbiota, Rowing, Females
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Krzysztof Durkalec-MichalskiUniversity, hospital or other
- Collaborators
- Institute of Human Genetics, Polish Academy of Sciences
- Study start
- 20 Nov 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this project is to evaluate and identify the effect of a short-term 2-week multi-strain probiotic (MPRO) supplementation on the exercise-associated gastrointestinal (GI) symptoms and perturbations in high level female athletes of the Polish national team during strictly controlled conditions of a training camp, based on recommendations for best practices for probiotic (PRO) research in athletes and assessment of EX-associated GI perturbations.
Detailed description
Objective of the study: GI health is crucial for the maintenance of general health and high performance in athletes. It is well known that GI symptoms are common in endurance athletes and that women are more likely to experience moderate or severe levels of symptoms. Exercise stress and external factors have an impact on GI health, leading to perturbations of GI integrity and functions negatively affecting performance outcomes. It is therefore necessary to develop treatment strategies capable of strengthening the GI health. Among the various preparations, PRO seem to induce improvements in intestinal diseases. There is a possible direct association between the reduced exercise-induced perturbations and cytokines, gut barrier function, and GI symptoms after PRO supplementation, but it has not been fully clarified yet. Moreover, it is stated that PRO benefits are strain-specific and dose-dependent, and include improved gut-barrier function, nutrient absorption, recovery and performance in athletes. Nevertheless, there is lack of well-designed studies on athletes population. Therefore, the main goal of the project is to evaluate and identify the effect of a short-term 2-week MPRO supplementation on the exercise- associated GI symptoms and perturbations in high level female rowers (particularly exposed to GI disturbances) of the Polish national team during completely controlled conditions of a training camp, based on recommendations for best practices for probiotic research in athletes and assessment of exercise-associated GI perturbations. The primary outcome is to recognize the MPRO supplementation effect on GI mechanisms, responsible for the occurrence of exercise-induced GI symptoms negatively affecting exercise performance. The following research hypotheses were adopted: A) considerable physical stress induced by high intensity exercises during national training camp contribute to the occurrence of GI disturbances; B) MPRO during high intensity training schedule may have a significant impact on specific key markers of GI perturbations; C) MPRO may have a positive effect on GI integrity; D) MPRO may have a beneficial effect on the systemic immune responses; E) MPRO may alter the fecal bacterial composition; F) MPRO may positively affect psychological stress and mood during high intensity training camp; G) MPRO may positively affect exercise performance outcomes.
Research project methodology: The study will be conducted in the standard of randomized, triple-blind, PLA-controlled crossover studies. A number of 30 high level female rowers will be enrolled. Specific MPRO strategy will be implemented. The assessment of body composition, exercise performance, baseline stool and baseline/post-exercise blood collection, GI and stress and mood status and nutrition will be performed. Samples will be analysed for: A) GI integrity markers permeability, bacterial endotoxin translocation, B) immune/stress responses' markers [inflammatory cytokine profile, immune cell response, C) exercise adaptation and intensity markers, D) stool GI integrity markers, E) fecal bacterial composition.
Expected impact of the research project on the development of science, practice and society: This completely innovative MPRO project will be conducted according to recently released recommendations for best practices for probiotic research in athletes and assessment of exercise-associated GI perturbations. Furthermore, recognizing the impact of MPRO on GI health could have beneficial implications for athletes, and people from the general population. An indisputable strength of our project is the fact that obtained data may be extrapolated into a real-world. Information on whether MPRO administration promotes proper GI health and physical training adaptation could be important for developing recommendations for PRO usage. Finally, the indisputable necessity of conducting research in the area of PRO is proved, in particular, by the abundance of GI disturbances, in terms of investigating natural methods in the prevention of GI symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MPRO supplementation | Experimental | Dietary Supplement: MPRO supplementationThe experimental procedure for each participant in this group will include a 2-week period of MPRO supplementation. The entire study protocol will include familiarization and 4 main study visits (T1-T4; before/after supplementation). Enrolled volunteers will be randomly assigned to the treatment order with specific codes by an impartial biostatistician. Each study visit will consist of anthropometric indices and body composition evaluation, three saliva and blood samplings (resting; 3 min and 60 min after exercise) and exercise performance evaluation. Additionally, all participants will donate their stool samples into specially prepared two empty tubes. Samples will be collected on the same days as saliva/blood samples, early in the morning. Moreover, during each study visit, participants will complete a specific, validated GI symptoms questionnaire and specific and validated stress and mood questionnaires to assess their stress and mood before and after MPRO supplementation. |
| PLA treatment | Placebo comparator | Dietary Supplement: Placebo treatmentThe experimental procedure for each participant in this group will include a 2-week period of placebo supplementation. The entire study protocol will include familiarization and 4 main study visits (T1-T4; before/after supplementation). Enrolled volunteers will be randomly assigned to the treatment order with specific codes by an impartial biostatistician. Each study visit will consist of anthropometric indices and body composition evaluation, three saliva and blood samplings (resting; 3 min and 60 min after exercise) and exercise performance evaluation. Additionally, all participants will donate their stool samples into specially prepared two empty tubes. Samples will be collected on the same days as saliva/blood samples, early in the morning. Moreover, during each study visit, participants will complete a specific, validated GI symptoms questionnaire and specific and validated stress and mood questionnaires to assess their stress and mood before and after placebo supplementation. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- belonging to the national rowing team;
- training experience ≥5 years;
- a currently issued medical certificate confirming
- good health and capacity to practice sports;
- good health without chronic health disorders;
Key exclusion criteria (11 listed)
- injury, any health contraindication or failure to perform exercise procedures;
- gastrointestinal infections, diseases, disorders;
- past history of gastrointestinal surgery, and
- other self-reported gastrointestinal issues;
- reporting symptoms of infection or taking any medication (e.g. antibiotics) for 4 weeks before the study protocol;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MPRO supplementationIn the experimental procedure each athlete will be supplemented with a certificated, commercially available MPRO supplement SANPROBI® Barrier (Bifidobacterium lactis W52, Lactobacillus brevis W63, Lactobacillus casei W56, Lactococcus lactis W19, Lactococcus lactis W58, Lactobacillus acidophilus W37, Bifidobacterium bifidum W23, Bifidobacterium lactis W51, Lactobacillus salivarius W24). The supplement will be provided in the capsule form and will be taken twice a day [4 capsules of MPRO/day (2×10to9 CFU/g, 500 milions CFU/capsule) in two servings/day (2x2 capsules]. | Dietary supplement | MPRO supplementation |
| Placebo treatmentIn the control procedure each athlete will be supplemented with a placebo (PLA). The PLA group will receive corn starch mixed with maltodextrins. The PLA will be provided in the capsule form and will be taken twice a day (2x2 capsules/day). | Dietary supplement | PLA treatment |
Primary outcome
Changes in gastrointestinal integrity and inflammation markers (I-FABP, claudin-3, zonulin, LPS, scd-14, LBP, ocludin, lipocalin-2, DAO) (ng/mL) in blood after MPRO supplementation and PLA treatment
Time frame: Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.
Assessment of the gastrointestinal integrity markers (I-FABP, claudin-3, zonulin, LPS, scd-14, LBP, ocludin, lipocalin-2, DAO) (ng/mL) in blood at three time-points (resting [REST]; 3 min [POST-EX] and 60 min after completion of the test exercise [REC]) will be carried out at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA).
Changes in gastrointestinal integrity and inflammation markers (zonulin, ocludin, lipocalin-2) (ng/mL) in stool after MPRO supplementation and PLA treatment
Time frame: Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.
Assessment of the gastrointestinal integrity markers (zonulin, ocludin, lipocalin-2) (ng/mL) in stool at rest will be carried out at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA).
Changes in gastrointestinal integrity and inflammation markers (calprotectin, lactoferrin) (μg/g) in stool after MPRO supplementation and PLA treatment
Time frame: Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.
Assessment of the gastrointestinal integrity markers (calprotectin, lactoferrin) (μg/g) in stool at rest will be carried out at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA).
Changes in gastrointestinal integrity and inflammation markers (α-1 antitripsin) (mg/g) in stool after MPRO supplementation and PLA treatment
Time frame: Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.
Assessment of the gastrointestinal integrity markers (α-1 antitripsin) (mg/g) in stool at rest will be carried out at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA).
Changes in gut microbiota phylogenetic diversity (Faith's phylogenetic diversity index) after MPRO supplementation and PLA treatment
Time frame: Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.
Assessment of phylogenetic α-diversity of the gut microbiome assessed from stool 16S rRNA gene sequencing; computed as Faith's Phylogenetic Diversity (sum of branch lengths on the phylogenetic tree corresponding to observed taxa) at rest will be carried out at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA).
Changes in gut microbiota species diversity (Shannon diversity index) after MPRO supplementation and PLA treatment
Time frame: Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.
Assessment of species (taxonomic) α-diversity of the gut microbiome assessed from stool 16S rRNA gene sequencing; computed using the Shannon diversity index (accounts for richness and evenness) at rest will be carried out at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA).
Changes in gut microbiota species richness (number of observed species (OTUs)) after MPRO supplementation and PLA treatment
Time frame: Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.
Assessment of species richness of the gut microbiome assessed from stool 16S rRNA gene sequencing; reported as the number of observed operational taxonomic units (Observed OTUs) at rest will be carried out at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA).
7 secondary outcomes
Changes in blood cytokines (IL-1β/1ra/6/8/10/17, TNF-α) (pg/mL) after MPRO supplementation and PLA treatment
Time frame: Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.
Changes in stress marker (cortisol) (ng/ml) in blood and saliva after MPRO supplementation and PLA treatment
Time frame: Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.
Changes in saliva SIgA concentration (μg/mL) after MPRO supplementation and PLA treatment
Time frame: Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.
Changes in gastrointestinal symptoms incidence and severity (points) after MPRO supplementation and PLA treatment
Time frame: Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.
Changes in psychological stress and mood (points) after MPRO supplementation and PLA treatment
Time frame: Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.
Changes in white blood cells count and differential (count/L) after MPRO supplementation and PLA treatment
Time frame: Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.
Changes in white blood cells count and differential (%) after MPRO supplementation and PLA treatment
Time frame: Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: Yes. Shared data will be exclusively related to the level of recorded indicators, without personal data. The data obtained will be attached to scientific publications, depending on the requirements of the journal. De-identified individual participant data (IPD), including timepoint-specific values of primary and secondary outcome measures (e.g., performance results, hematological and physiological parameters), will be shared. Data will be made available upon reasonable request to qualified researchers for non-commercial academic purposes, following publication of the primary results. Requests should be directed to the corresponding author via institutional email. A data use agreement may be required.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Krzysztof Durkalec-Michalski, PhD contact
Krzysztof Durkalec-Michalski, PhD study chair
Department of Sports Dietetics, Poznan University of Physical Education Poznań
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing MPRO supplementation in people with Sports Nutrition and Biochemical Markers, run by Krzysztof Durkalec-Michalski at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalia Główka, PhD (+48 691 756 944, glowka@awf.poznan.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in gastrointestinal integrity and inflammation markers (I-FABP, claudin-3, zonulin, LPS, scd-14, LBP, ocludin, lipocalin-2, DAO) (ng/mL) in blood after MPRO supplementation and PLA treatment (time frame: Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.