Effect of a Short-term Multi-strain Probiotic Supplementation in Endurance Athletes

Krzysztof Durkalec-Michalski

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Supplementation; Aerobic Capacity; Biochemical Markers; Sports Nutrition; Exercise Performance

Treatments: Dietary Supplement: Placebo treatment; Dietary Supplement: MPRO supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT07252778

ZDS2025_0002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 16 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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,
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

MPRO supplementation

Experimental group

Description:

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.

Treatment:

Dietary Supplement: MPRO supplementation

PLA treatment

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo treatment