Actively Recruiting

Phase 2
Phase 3
Age: 16Years - 50Years
FEMALE
Healthy Volunteers
ID07252778

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

Led by Krzysztof Durkalec-Michalski · Updated on 2025-11-28

30

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

K

Krzysztof Durkalec-Michalski

Lead Sponsor

I

Institute of Human Genetics, Polish Academy of Sciences

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate the effect of a short-term 2-week multi-strain probiotic (MPRO) supplementation on exercise-related gastrointestinal (GI) symptoms and disturbances in high-level female rowers from the Polish national team. The study focuses on how probiotics might influence GI integrity, immune responses, fecal bacterial composition, psychological stress, mood, and exercise performance during intense training. Women are particularly studied due to their higher likelihood of experiencing moderate to severe GI symptoms during endurance activities. Participants will receive either the MPRO supplement or a placebo in a randomized, triple-blind, placebo-controlled crossover design. Each supplementation period lasts two weeks. The MPRO supplement includes several probiotic strains in capsules taken twice daily, while the placebo contains corn starch and maltodextrins in identical capsule form. The study includes familiarization and four main visits before and after supplementation periods, where various biological samples and questionnaires are collected. During each visit, participants undergo body composition measurements, saliva and blood sampling at rest and post-exercise, stool sample collection, and exercise performance assessments. They also complete validated GI symptoms and stress/mood questionnaires. Researchers will measure changes in gastrointestinal integrity and inflammation markers in blood and stool, gut microbiota diversity, cytokines, stress hormones, immune cell counts, GI symptoms, mood, and performance outcomes. The study is expected to last until June 2027 with comprehensive monitoring under controlled training conditions.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 16Years - 50Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Belonging to the national rowing team
  • Training experience of at least 5 years
  • Currently have a medical certificate confirming good health and capacity to practice sports
  • Good health without chronic health disorders
  • Provide written informed consent to participate
Not Eligible

You will not qualify if you...

  • Injury or any health condition preventing exercise procedures
  • Gastrointestinal infections, diseases, or disorders
  • History of gastrointestinal surgery or other gastrointestinal issues
  • Symptoms of infection or medication use (e.g., antibiotics) within 4 weeks before the study
  • Current supplementation with prebiotics, probiotics, or synbiotics within last 4 weeks
  • Use of certain pharmaceutical agents (e.g., anti-inflammatory drugs, laxatives) within last 4 weeks
  • Failure to follow the study protocol
  • General feeling of being unwell
  • Pregnancy or planning pregnancy

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 2 weeks per supplementation period

Participants will undergo two separate 2-week supplementation periods with either the MPRO probiotic supplement or a placebo. During each supplementation period, participants will take capsules twice daily and attend study visits where body composition, exercise performance, blood and saliva samples, stool samples, and questionnaires on gastrointestinal symptoms, stress, and mood will be collected.

4 main study visits (before and after each supplementation period)

Trial Site Locations

Total: 1 location

1

Department of Sports Dietetics, Poznan University of Physical Education Poznań

Poznan, Wielkopolska, Poland, 61-871

Actively Recruiting

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Research Team

N

Natalia Główka, PhD

K

Krzysztof Durkalec-Michalski, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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