The Effect of Probiotic Supplementation on the Exercise Performance of Long-distance Runners.

NCT07411482 | Active Not Recruiting DMC

• 2 other identifiers: Runners20232021/41/N/NZ4/02364
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed as a randomized double-blind placebo-controlled clinical trial with a 4-week probiotics intervention period. The study will be conducted between January 2022 and March 2025 at the Medical University of Gdańsk, Department of Bioenergetics and Physiology of Exercise (Gdańsk, Poland). A total of 40 endurance-trained adult men, specifically long-distance runners with previous experience in marathon races, will be enrolled. Only participants who meet all inclusion criteria and do not meet any exclusion criteria will be included in the study. Participants will be randomly assigned to the probiotic (PRO) or placebo (PL) group in a 1:1 ratio. Athletes will supplement 4 capsules of the study product (probiotic mixture) daily. To eliminate the effect of diet on the gut microbiome, all athletes will receive an individually balanced box diet designed to provide 100% of energy requirements, protein intake of 1.6 g/kg/day, and at least 8 g/kg/day of carbohydrates. Participants will continue their training programs and perform at least 5 endurance workouts per week. To assess training loads, athletes will report average pulse range, subjective fatigue, and duration of training sessions. The investigators will examine whether 4 weeks of probiotic supplementation in conjunction with a personalized diet may have a direct or indirect influence on sport performance. This will be assessed through evaluation of aerobic fitness capacity using treadmill tests. The cardiopulmonary exercise test (CPET) will determine maximum oxygen uptake, minute lung ventilation, and heart rate. Body composition analysis and assessments of blood and fecal samples will also be performed. Blood samples will be analyzed for serum pro-inflammatory cytokines (IL-6 and TNF-α). Collected fecal samples will be subjected to quantitative and qualitative analysis of the intestinal microbiota using next-generation sequencing. The analysis will include intestinal permeability markers (calprotectin, zonulin, IFABP) and bacterial metabolism products such as short-chain fatty acids (SCFA). All assessments and procedures will be carried out both before and immediately after the supplementation period. All obtained data will undergo statistical analysis. Descriptive statistics will be used for background information and to examine trends in the analyzed parameters, with mean values and 95% confidence intervals. Depending on the distribution of the data, parametric or non-parametric tests will be applied. Statistical significance will be set at p \< 0.05. To the best of the investigators' knowledge, this will be the first intervention study comprehensively assessing the influence of probiotic supplementation in conjunction with a standardized diet on inflammatory response, intestinal permeability, gut microbiome composition, and aerobic capacity of competitive long-distance runners. The collected data will provide evidence regarding the potential influence of probiotic supplementation on parameters of sport performance.

Conditions

Intestinal Microbiome; Probiotic; Runners

Keywords

Probiotisc; athletes; runners; intestinal mucosal unction

Outcome Measures

Primary Outcomes (2)

• The assessment of the impact of probiotic supplementation on maximal oxygen uptake value among athletes.

  Aerobic capacity will be assessed using an incremental treadmill test performed to volitional exhaustion. After a brief standing period on the treadmill to ensure stabilization of the measurement equipment, participants will complete a standardized low-intensity warm-up, followed by a stepwise increase in exercise intensity until exhaustion. Heart rate will be continuously monitored (Polar Electro Oy, Kempele, Finland), and respiratory variables (VO₂, VCO₂, VE, and RER) will be measured breath-by-breath using a calibrated metabolic cart (Oxycon Pro, Jaeger, Germany). Peak oxygen uptake (VO₂peak) will be defined as the highest value recorded during the test.

  Baseline visit (before supplementation period) and after 4 weeks of supplementation period (post-intervention).

• Analysis of gut microbiome

  Fecal samples will be collected by participants before and after the 4-week intervention period using standardized containers. Samples will be immediately frozen at -80°C and analyzed by an independent laboratory. The intestinal microbiota will be assessed using next-generation sequencing of selected 16S rRNA gene regions. Microbiome composition will be characterized by alpha diversity (Chao1, ACE, Shannon, inverted Simpson) and beta diversity (Bray-Curtis and weighted UniFrac), and analyzed in relation to intestinal permeability markers (calprotectin, zonulin, IFABP) and bacterial metabolites (short-chain fatty acids, SCFA).

  Baseline (pre-intervention) and after 4 weeks of supplementation (post-intervention).

Secondary Outcomes (1)

• Assessment of inflammatroy state

  Baseline (pre-supplementation) and after 4 weeks of supplementation (post-intervention), with blood samples collected immediately before exercise and 30 minutes after the exercise test.

Study Arms (2)

A

EXPERIMENTAL

Participants who supplement probiotics or placebo

Dietary Supplement: probiotics or placebo; Dietary Supplement: Box diet

B

EXPERIMENTAL

Participants who supplement probiotics or placebo

Dietary Supplement: probiotics or placebo; Dietary Supplement: Box diet

Interventions

probiotics or placebo DIETARY_SUPPLEMENT

The study product is a probiotic mixture Sanprobi Active \& Sport, containing 2,5 x 109 CFU/g per capsule (≥500 million CFU in one capsule) of five strains of lactic acid bacteria (Bifidobacterium lactis W51, Lactobacillus brevis W63, Lactobacillus acidophilus W22, Bifidobacterium bifidum W23 and Lactococcus lactis W5); maize starch, maltodextrin, plant proteins and hydroxypropyl ethylcellulose tablets' coating. OR PLACEBo identically-looked

A; B

Box diet DIETARY_SUPPLEMENT

To eliminate the effect of diet on the gut microbiome, all athletes received optimal, individually-balanced box-diet.

Also known as: GroupA

A; B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Endurance-trained adult men (aged ≥ 18 years)
• Long-distance runners with experience in at least three marathons or half-marathons
• Average running speed between 10.549 and 14.065 km/h
• At least 3 years of regular endurance training experience
• Completion of 5 or more training sessions per week

You may not qualify if:

• Age below 18 years
• Female gender
• Antibiotic therapy within the last 3 months
• Diagnosed inflammatory bowel disease
• Chronic musculoskeletal injuries within the last 6 months
• Heart failure or heart defects

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Medical University of Gdańsk

Gdansk, Poland

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

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

Model Details: double-blinded placebo controlled trial

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: February 13, 2026
• Study Start: December 1, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)