Microbial CompositionNCT07585474
Gut Microbiome Response to Long-Haul Travel in Elite Football Players
A study testing Probiotic Capsule in people with Microbial Composition and Immune Function, run by Sheffield Hallam University at 2 sites in 2 countries.
Trial summary
The goal of this randomised control trial is to measure the gut microbiome response to long-haul travel alongside the demands of pre-season amongst elite football players. The efficacy of a probiotic in modulating the gut microbiome to mitigate the detrimental impacts of long-haul travel as well as training in the… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Microbial Composition, Immune Function
- What is being tested?
- Probiotic Capsule
- 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
- 2 sitesin 2 countries
- Study dates
- 25 Jul 2025to 15 Aug 2026
- Phase
- Interventional
- 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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male professional footballers who are involved in regular training during the pre-season period.
- Generally healthy, with no acute or chronic illnesses that could interfere with the study intervention or outcomes.
- Not currently consuming probiotics, prebiotics, or antibiotics within 4 weeks prior to enrolment.
- Willing to refrain from starting any new dietary supplements or probiotics during the study period.
- Able and willing to provide written informed consent.
Who cannot join
- History of gastrointestinal disorders (e.g., Crohn's disease, ulcerative colitis, irritable bowel syndrome) or chronic diseases that could interfere with probiotic metabolism or study outcomes.
- Acute illness (e.g., infection) within 2 weeks prior to enrollment.
- Known allergy or hypersensitivity to components of the probiotic or placebo. - - - Use of antibiotics, probiotics, prebiotics, or synbiotics within 4 weeks prior to study start.
- Use of immunosuppressive medications or other supplements likely to impact gut microbiota.
- Regular use of alcohol or drugs at levels that could interfere with study participation or outcomes.
- Participation in another clinical trial within the past 3 months.
- Any injury or medical condition that limits participation in full training or matches during the study period.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
About this study
The goal of this randomised control trial is to measure the gut microbiome response to long-haul travel alongside the demands of pre-season amongst elite football players. The efficacy of a probiotic in modulating the gut microbiome to mitigate the detrimental impacts of long-haul travel as well as training in the heat will also be explored.
The main questions this study aims to answer are:
Read more
- How is the gut microbiome of the professional football player impacted by long-haul travel during the pre-season period?
- How is immune function impacted by the demands of pre-season?
- Can a probiotic dietary maintain gut microbial stability in response to long-haul travel? Researchers will compare the effects of the probiotic supplement with a placebo.
Participants will be required to:
- Provide a faecal sample at multiple points throughout the pre-season
- Provide a saliva sample at multiple points throughout the season
- Consume a daily supplement which will either be a placebo or probiotic capsule
Read the detailed description
Study Overview During the pre-season period it has become increasingly popular for professional football teams to travel to locations such as North America, Asia and Australia in attempts to maximise commercial revenue. The gut microbiome, the diverse bacterial community known to influence key physiological processes, has been shown to be negatively impacted by long-haul travel. As a result, elite athletes may benefit from dietary interventions to mitigate these negative impacts especially when considering the intense heat and physical demands of a pre-season camp conditions which have been shown to induce gut dysbiosis.
This study will firstly attempt to highlight the impact of long-haul travel on the gut microbiome of professional football players. It will also attempt to determine the efficacy of a probiotic dietary intervention in maintaining gut microbial stability in response to long-haul travel. A randomised, placebo-controlled trial will be utilised whereby players will consume either a daily probiotic or placebo. In addition, players will provide multiple faecal samples at specific time points; 1) arrival from the off-season break, 2) prior to the pre-season tour flight, 3) upon arrival to the pre-season tour destination, and 4) within five days of arriving back in UK. It is predicted that the probiotic intervention will result in greater microbial diversity and lead to a reduction in abundance of pathogenic bacterial strains typically seen following long-haul travel.
Background \& Rationale The human gut microbiome is a sophisticated eco-system of microorganisms comprised of bacteria, archaea, fungi and viruses. This rich and diverse microbial community actively contributes to physiological processes such as energy metabolism, nutrient uptake and immune response. It is accepted that both the intensity and pattern of physical activity alters the composition of the gut microbiome and there is growing interest regarding the bidirectional association between exercise and the gut microbiome.
One sporting context which has seen a growing body of literature in this area is professional football. The professional football player is required to play up to 50 matches a season with regular periods of congested fixtures often played every 4 days for as long as 3 consecutive weeks. Given that the gut microbiota is heavily involved in the production and storage of energy, processes which are vital to meet the demands of physical performance, a suboptimal gut microbiota configuration may have a significant influence over players performance. As a result of the demands of the professional football player it is vital that such implications are avoided. Various authors have investigated the gut microbiome of the professional footballer across a range of study designs within both male and female cohorts. The results of these studies appear promising with findings suggesting that certain dietary strategies can maintain gut microbial stability and that elite players demonstrate higher prevalence of beneficial microbial populations compared with less active subjects.
When considering microbial stability several factors have a drastic impact on functional richness and microbial diversity. One such factor is travel, with short-term travel having been found to increase intra-individual gut microbiota fluctuations in non-athlete populations. These changes appear to be influenced by the composition of the gut microbiota prior to travel. In addition, international travel combined with dietary changes has been shown to negatively impact the gut microbiome of elite athletes, with reductions in microbial diversity and shifts in taxonomic profiles. However, to date no studies have explored the impact of long-haul travel on the gut microbiome of the professional footballer, highlighting an immediate gap in the literature.
In attempts to maximise commercial opportunities, modern football pre-season tours now regularly involve trips to locations such as North America or Asia. Pre-season tours outside of Europe have also become increasingly important for Premier League clubs as they serve as a vehicle for creating and maintaining strategic partnerships. As a result, players face the prospect of an annual long-haul trip in the pre-season period emphasising the importance of strategies to mitigate negative impacts on player well-being.
The pre-season period is characterised by high intensity tactical and technical training sessions to re-establish fitness following the off-season. Players often complete multiple training sessions per day and are therefore subjected to greater training loads compared to the in-season period. Pre-season tour destinations also typically present hot and humid environmental conditions, increasing exposure to heat stress which can impair performance and pose health risks. Exposure to these stimuli may have a detrimental effect on gut health by reducing functionality and causing gut dysbiosis. This combined with the requirement of long-haul travel presents an opportunity to explore the resilience and sensitivity of the gut microbiome during this period.
While the association between exercise and the gut microbiome is well established, understanding of dietary interventions to modulate the gut microbiome is still evolving. One commonly used approach involves providing live microorganisms to manipulate gut microbiome composition and correct perturbations. Probiotics are defined as live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. However, there remains a lack of research investigating probiotic interventions in elite football populations. Existing evidence suggests probiotic-rich foods may increase microbial diversity in professional players, but further investigation is required.
Considering the above, it is reasonable to postulate that a dietary intervention aimed at modulating the gut microbiome may mitigate disturbances associated with long-haul travel and intensive pre-season training in hot and humid conditions. Therefore, this study will explore the impact of long-haul travel on the gut microbiome composition of elite football players and assess whether a probiotic intervention helps maintain gut microbial stability during a Premier League pre-season schedule.
Main Research Questions
- How does long-haul travel impact the gut microbiome composition of elite football players?
- Does a probiotic intervention offset gut microbiome disruptions associated with long-haul travel?
- Is there an added impact of environmental factors and training load on gut microbiome composition?
Methods Study Design This study will be designed as a randomised control trial to investigate the impact of long-haul travel on the gut microbiome of professional football players and explore whether probiotic supplementation offsets observed disruptions. Sample size will be calculated using GPower based on previous research demonstrating significant changes in microbial diversity following dietary interventions. A large expected effect size and statistical power of 80% will be used for an a priori sample size calculation.
Players will be randomly divided into two groups: 1) intervention (daily probiotic) and 2) control (daily placebo). Randomisation will be conducted using an online computer-generated tool. The intervention group will consume a probiotic capsule daily with their first meal, beginning five days prior to departure. Prior to travel, players will follow a structured training schedule with controlled nutrition provided by club staff. This approach aims to minimise inter-individual variability and establish a stable baseline gut microbiome prior to travel.
Dietary Assessment Direct dietary recording throughout the study period will not be feasible. However, dietary intake will be highly controlled as players will consume most meals at the training ground or team hotel, prepared from pre-planned menus by the club's Head Chef. This provides substantial control over food quality and nutrient intake and limits variability seen in free-living environments.
Salivary Immunoglobin A Long-haul travel and environmental stressors may disrupt immune homeostasis and increase susceptibility to illness. Salivary immunoglobin A will be monitored as a biomarker of immune function. Samples will be collected at baseline and multiple time points during travel using a standardised collection protocol. Samples will be analysed using a lateral flow device, with results recorded and stored by the lead researcher.
Gastrointestinal Symptoms Players will complete a daily gastrointestinal symptom questionnaire where possible to capture subjective responses to long-haul travel. The questionnaire assesses symptoms across multiple domains including reflux, abdominal pain, indigestion, diarrhoea and constipation using a 7-point Likert scale. This information will provide important contextual insight alongside microbiome data.
Temperature \& Humidity Environmental conditions will be monitored using a heat stress tracker to measure temperature, humidity and heat stress indices. Measurements will be taken before and after each training session to quantify environmental exposure.
Faecal Sample Collection \& Analysis Players will provide four faecal samples across the study period to assess changes in gut microbiome composition. Samples will be collected using validated self-collection methods and preserved for transport and storage. Samples collected in the UK will be frozen and processed within one month.
Faecal samples will be analysed using 16S rRNA sequencing. Alpha and beta diversity metrics will be used to assess microbial diversity and community composition. Statistical analyses will evaluate within- and between-group changes across time points. Differential abundance analysis and correlation testing will be performed using appropriate statistical software, with adjustments made for multiple comparisons.
- Conditions
- Microbial Composition, Immune Function
- Being tested
- Probiotic Capsule, Placebo
- Keywords
- Gut microbiome, Probiotics, Pre-Season, Football, Long-Haul, Travel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic CapsuleDrug
Probiotic capsule administered orally once daily for 3 weeks
PlaceboDrug
Placebo tablet, identical in appearance to probiotic, administered orally once daily for 3-4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment Group | Experimental | All participants receive probiotic once orally for 3-4 weeks Receives: Drug: Probiotic Capsule |
| Placebo | Placebo comparator | Participants receive matching placebo orally once daily for 3-4 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut Microbiome
The gut microbiome is the complex community of microorganisms in the gastrointestinal tract that plays a vital role in digestion, immune regulation, and overall physiological resilience. In elite athletes, long-haul travel and pre-season training in hot environments can place additional stress on the gastrointestinal system, potentially leading to dysbiosis, gastrointestinal discomfort, and impaired performance or recovery.
Measured: 3-4 weeks
Secondary outcomes (1)
Salivary IgA
Salivary immunoglobulin A (sIgA) is a key antibody in mucosal secretions that provides a first line of defence against pathogens entering through the oral cavity and upper respiratory tract. In elite athletes, prolonged physical exertion, heat stress, and long-haul travel can suppress sIgA levels, increasing susceptibility to respiratory infections and impairing overall immune function.
Measured: 3-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start25 Jul 2025
- Primary completion18 Aug 2025
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Microbial CompositionStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Randomised Control Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Hallam University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leeds
- Responsible party
- Principal investigator, Tony Lynn, Sheffield Hallam University
- Investigators
- George Davis, Masters, Principal investigator, Sheffield Hallam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585474
- Sponsor's protocol ID
- ER79032366
- Status last verified
- May 2026
- First submitted
- 21 Jul 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study involves a small population of elite athletes, and sharing detailed participant data could risk breaching confidentiality and anonymity. In addition, there are no plans for secondary analyses requiring IPD sharing.
Publications
References Bielik, V., Hric, I., Ugrayová, S., Kubáňová, L., Putala, M., Grznár, Ľ., Penesová, A., Havranová, A., Šardzíková, S. and Grendar, M. (2022) Effect of high-intensity training and probiotics on gut microbiota diversity in competitive swimmers: randomized controlled trial. Sports medicine-open, 8(1), p. 64. Borg, G. A. (1982) Psychophysical bases of perceived exertion. Medicine and science in sports and exercise, 14(5), pp. 377-381. Cani, P. D., Van Hul, M., Lefort, C., Depommier, C., Rastelli, M. and Everard, A. (2019) Microbial regulation of organismal energy homeostasis. Nature metabolism, 1(1), pp. 34-46. Casa, D. J., Becker, S. M., Ganio, M. S., Brown, C. M., Yeargin, S. W., Roti, M. W., Siegler, J., Blowers, J. A., Glaviano, N. R. and Huggins, R. A. (2007) Validity of devices that assess body temperature during outdoor exercise in the heat. Journal of athletic training, 42(3), p. 333. Chantler, S., Wood-Martin, R., Holliday, A., Davison, G., Crabtree, D. R., Readhead, C. and Jones, B. (2024) The frequency and severity of gastrointestinal symptoms in rugby players. International Journal of Sports Medicine, 45(04), pp. 323-221. Cinca-Morros, S. and Álvarez-Herms, J. (2024) The importance of maintaining and improving a healthy gut microbiota in athletes as a preventive strategy to improve heat tolerance and acclimatization. Microorganisms, 12(6), p. 1160. Donnan, K., Williams, E. L. and Stanger, N. (2021) The effects of heat exposure during intermittent exercise on physical and cognitive performance among team sport athletes. Perceptual and Motor Skills, 128(1), pp. 439-466. Fassarella, M., Blaak, E. E., Penders, J., Nauta, A., Smidt, H. and Zoetendal, E. G. (2021) Gut microbiome stability and resilience: elucidating the response to perturbations in order to modulate gut health. Gut, 70(3), pp. 595-605. Fessi, M. S., Nouira, S., Dellal, A., Owen, A., Elloumi, M. and Moalla, W. (2016) Changes of the psychophysical state and feeling of wellness of
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiome Response to Long-Haul Travel in Elite Football Players
- ClinicalTrials.gov ID
- NCT07585474
- Acronym / sponsor ID
- ER79032366
- Conditions
- Microbial Composition, Immune Function
- Keywords
- Gut microbiome, Probiotics, Pre-Season, Football, Long-Haul, Travel
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sheffield Hallam UniversityUniversity, hospital or other
- Collaborators
- University of Leeds
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 18 Aug 2025 (actual)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 13 May 2026 (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 goal of this randomised control trial is to measure the gut microbiome response to long-haul travel alongside the demands of pre-season amongst elite football players. The efficacy of a probiotic in modulating the gut microbiome to mitigate the detrimental impacts of long-haul travel as well as training in the heat will also be explored.
The main questions this study aims to answer are:
- How is the gut microbiome of the professional football player impacted by long-haul travel during the pre-season period?
- How is immune function impacted by the demands of pre-season?
- Can a probiotic dietary maintain gut microbial stability in response to long-haul travel? Researchers will compare the effects of the probiotic supplement with a placebo.
Participants will be required to:
- Provide a faecal sample at multiple points throughout the pre-season
- Provide a saliva sample at multiple points throughout the season
- Consume a daily supplement which will either be a placebo or probiotic capsule
Detailed description
Study Overview During the pre-season period it has become increasingly popular for professional football teams to travel to locations such as North America, Asia and Australia in attempts to maximise commercial revenue. The gut microbiome, the diverse bacterial community known to influence key physiological processes, has been shown to be negatively impacted by long-haul travel. As a result, elite athletes may benefit from dietary interventions to mitigate these negative impacts especially when considering the intense heat and physical demands of a pre-season camp conditions which have been shown to induce gut dysbiosis.
This study will firstly attempt to highlight the impact of long-haul travel on the gut microbiome of professional football players. It will also attempt to determine the efficacy of a probiotic dietary intervention in maintaining gut microbial stability in response to long-haul travel. A randomised, placebo-controlled trial will be utilised whereby players will consume either a daily probiotic or placebo. In addition, players will provide multiple faecal samples at specific time points; 1) arrival from the off-season break, 2) prior to the pre-season tour flight, 3) upon arrival to the pre-season tour destination, and 4) within five days of arriving back in UK. It is predicted that the probiotic intervention will result in greater microbial diversity and lead to a reduction in abundance of pathogenic bacterial strains typically seen following long-haul travel.
Background \& Rationale The human gut microbiome is a sophisticated eco-system of microorganisms comprised of bacteria, archaea, fungi and viruses. This rich and diverse microbial community actively contributes to physiological processes such as energy metabolism, nutrient uptake and immune response. It is accepted that both the intensity and pattern of physical activity alters the composition of the gut microbiome and there is growing interest regarding the bidirectional association between exercise and the gut microbiome.
One sporting context which has seen a growing body of literature in this area is professional football. The professional football player is required to play up to 50 matches a season with regular periods of congested fixtures often played every 4 days for as long as 3 consecutive weeks. Given that the gut microbiota is heavily involved in the production and storage of energy, processes which are vital to meet the demands of physical performance, a suboptimal gut microbiota configuration may have a significant influence over players performance. As a result of the demands of the professional football player it is vital that such implications are avoided. Various authors have investigated the gut microbiome of the professional footballer across a range of study designs within both male and female cohorts. The results of these studies appear promising with findings suggesting that certain dietary strategies can maintain gut microbial stability and that elite players demonstrate higher prevalence of beneficial microbial populations compared with less active subjects.
When considering microbial stability several factors have a drastic impact on functional richness and microbial diversity. One such factor is travel, with short-term travel having been found to increase intra-individual gut microbiota fluctuations in non-athlete populations. These changes appear to be influenced by the composition of the gut microbiota prior to travel. In addition, international travel combined with dietary changes has been shown to negatively impact the gut microbiome of elite athletes, with reductions in microbial diversity and shifts in taxonomic profiles. However, to date no studies have explored the impact of long-haul travel on the gut microbiome of the professional footballer, highlighting an immediate gap in the literature.
In attempts to maximise commercial opportunities, modern football pre-season tours now regularly involve trips to locations such as North America or Asia. Pre-season tours outside of Europe have also become increasingly important for Premier League clubs as they serve as a vehicle for creating and maintaining strategic partnerships. As a result, players face the prospect of an annual long-haul trip in the pre-season period emphasising the importance of strategies to mitigate negative impacts on player well-being.
The pre-season period is characterised by high intensity tactical and technical training sessions to re-establish fitness following the off-season. Players often complete multiple training sessions per day and are therefore subjected to greater training loads compared to the in-season period. Pre-season tour destinations also typically present hot and humid environmental conditions, increasing exposure to heat stress which can impair performance and pose health risks. Exposure to these stimuli may have a detrimental effect on gut health by reducing functionality and causing gut dysbiosis. This combined with the requirement of long-haul travel presents an opportunity to explore the resilience and sensitivity of the gut microbiome during this period.
While the association between exercise and the gut microbiome is well established, understanding of dietary interventions to modulate the gut microbiome is still evolving. One commonly used approach involves providing live microorganisms to manipulate gut microbiome composition and correct perturbations. Probiotics are defined as live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. However, there remains a lack of research investigating probiotic interventions in elite football populations. Existing evidence suggests probiotic-rich foods may increase microbial diversity in professional players, but further investigation is required.
Considering the above, it is reasonable to postulate that a dietary intervention aimed at modulating the gut microbiome may mitigate disturbances associated with long-haul travel and intensive pre-season training in hot and humid conditions. Therefore, this study will explore the impact of long-haul travel on the gut microbiome composition of elite football players and assess whether a probiotic intervention helps maintain gut microbial stability during a Premier League pre-season schedule.
Main Research Questions
- How does long-haul travel impact the gut microbiome composition of elite football players?
- Does a probiotic intervention offset gut microbiome disruptions associated with long-haul travel?
- Is there an added impact of environmental factors and training load on gut microbiome composition?
Methods Study Design This study will be designed as a randomised control trial to investigate the impact of long-haul travel on the gut microbiome of professional football players and explore whether probiotic supplementation offsets observed disruptions. Sample size will be calculated using GPower based on previous research demonstrating significant changes in microbial diversity following dietary interventions. A large expected effect size and statistical power of 80% will be used for an a priori sample size calculation.
Players will be randomly divided into two groups: 1) intervention (daily probiotic) and 2) control (daily placebo). Randomisation will be conducted using an online computer-generated tool. The intervention group will consume a probiotic capsule daily with their first meal, beginning five days prior to departure. Prior to travel, players will follow a structured training schedule with controlled nutrition provided by club staff. This approach aims to minimise inter-individual variability and establish a stable baseline gut microbiome prior to travel.
Dietary Assessment Direct dietary recording throughout the study period will not be feasible. However, dietary intake will be highly controlled as players will consume most meals at the training ground or team hotel, prepared from pre-planned menus by the club's Head Chef. This provides substantial control over food quality and nutrient intake and limits variability seen in free-living environments.
Salivary Immunoglobin A Long-haul travel and environmental stressors may disrupt immune homeostasis and increase susceptibility to illness. Salivary immunoglobin A will be monitored as a biomarker of immune function. Samples will be collected at baseline and multiple time points during travel using a standardised collection protocol. Samples will be analysed using a lateral flow device, with results recorded and stored by the lead researcher.
Gastrointestinal Symptoms Players will complete a daily gastrointestinal symptom questionnaire where possible to capture subjective responses to long-haul travel. The questionnaire assesses symptoms across multiple domains including reflux, abdominal pain, indigestion, diarrhoea and constipation using a 7-point Likert scale. This information will provide important contextual insight alongside microbiome data.
Temperature \& Humidity Environmental conditions will be monitored using a heat stress tracker to measure temperature, humidity and heat stress indices. Measurements will be taken before and after each training session to quantify environmental exposure.
Faecal Sample Collection \& Analysis Players will provide four faecal samples across the study period to assess changes in gut microbiome composition. Samples will be collected using validated self-collection methods and preserved for transport and storage. Samples collected in the UK will be frozen and processed within one month.
Faecal samples will be analysed using 16S rRNA sequencing. Alpha and beta diversity metrics will be used to assess microbial diversity and community composition. Statistical analyses will evaluate within- and between-group changes across time points. Differential abundance analysis and correlation testing will be performed using appropriate statistical software, with adjustments made for multiple comparisons.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Randomised Control Trial
| Arm | Type | Receives |
|---|---|---|
| Active Treatment Group | Experimental | Drug: Probiotic CapsuleAll participants receive probiotic once orally for 3-4 weeks |
| Placebo | Placebo comparator | Drug: PlaceboParticipants receive matching placebo orally once daily for 3-4 weeks |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male professional footballers who are involved in regular training during the pre-season period.
- Generally healthy, with no acute or chronic illnesses that could interfere with the study intervention or outcomes.
- Not currently consuming probiotics, prebiotics, or antibiotics within 4 weeks prior to enrolment.
- Willing to refrain from starting any new dietary supplements or probiotics during the study period.
- Able and willing to provide written informed consent.
Key exclusion criteria (7 listed)
- History of gastrointestinal disorders (e.g., Crohn's disease, ulcerative colitis, irritable bowel syndrome) or chronic diseases that could interfere with probiotic metabolism or study outcomes.
- Acute illness (e.g., infection) within 2 weeks prior to enrollment.
- Known allergy or hypersensitivity to components of the probiotic or placebo. - - - Use of antibiotics, probiotics, prebiotics, or synbiotics within 4 weeks prior to study start.
- Use of immunosuppressive medications or other supplements likely to impact gut microbiota.
- Regular use of alcohol or drugs at levels that could interfere with study participation or outcomes.
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 |
|---|---|---|
| Probiotic CapsuleProbiotic capsule administered orally once daily for 3 weeks | Drug | Active Treatment Group |
| PlaceboPlacebo tablet, identical in appearance to probiotic, administered orally once daily for 3-4 weeks. | Drug | Placebo |
Primary outcome
Gut Microbiome
Time frame: 3-4 weeks
The gut microbiome is the complex community of microorganisms in the gastrointestinal tract that plays a vital role in digestion, immune regulation, and overall physiological resilience. In elite athletes, long-haul travel and pre-season training in hot environments can place additional stress on the gastrointestinal system, potentially leading to dysbiosis, gastrointestinal discomfort, and impaired performance or recovery.
1 secondary outcome
Salivary IgA
Time frame: 3-4 weeks
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 13 May 2026.
- BackgroundReferences Bielik, V., Hric, I., Ugrayová, S., Kubáňová, L., Putala, M., Grznár, Ľ., Penesová, A., Havranová, A., Šardzíková, S. and Grendar, M. (2022) Effect of high-intensity training and probiotics on gut microbiota diversity in competitive swimmers: randomized controlled trial. Sports medicine-open, 8(1), p. 64. Borg, G. A. (1982) Psychophysical bases of perceived exertion. Medicine and science in sports and exercise, 14(5), pp. 377-381. Cani, P. D., Van Hul, M., Lefort, C., Depommier, C., Rastelli, M. and Everard, A. (2019) Microbial regulation of organismal energy homeostasis. Nature metabolism, 1(1), pp. 34-46. Casa, D. J., Becker, S. M., Ganio, M. S., Brown, C. M., Yeargin, S. W., Roti, M. W., Siegler, J., Blowers, J. A., Glaviano, N. R. and Huggins, R. A. (2007) Validity of devices that assess body temperature during outdoor exercise in the heat. Journal of athletic training, 42(3), p. 333. Chantler, S., Wood-Martin, R., Holliday, A., Davison, G., Crabtree, D. R., Readhead, C. and Jones, B. (2024) The frequency and severity of gastrointestinal symptoms in rugby players. International Journal of Sports Medicine, 45(04), pp. 323-221. Cinca-Morros, S. and Álvarez-Herms, J. (2024) The importance of maintaining and improving a healthy gut microbiota in athletes as a preventive strategy to improve heat tolerance and acclimatization. Microorganisms, 12(6), p. 1160. Donnan, K., Williams, E. L. and Stanger, N. (2021) The effects of heat exposure during intermittent exercise on physical and cognitive performance among team sport athletes. Perceptual and Motor Skills, 128(1), pp. 439-466. Fassarella, M., Blaak, E. E., Penders, J., Nauta, A., Smidt, H. and Zoetendal, E. G. (2021) Gut microbiome stability and resilience: elucidating the response to perturbations in order to modulate gut health. Gut, 70(3), pp. 595-605. Fessi, M. S., Nouira, S., Dellal, A., Owen, A., Elloumi, M. and Moalla, W. (2016) Changes of the psychophysical state and feeling of wellness of
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study involves a small population of elite athletes, and sharing detailed participant data could risk breaching confidentiality and anonymity. In addition, there are no plans for secondary analyses requiring IPD sharing.
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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.
George Davis, Masters principal investigator
Sheffield Hallam University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Capsule in people with Microbial Composition and Immune Function, run by Sheffield Hallam University at 2 sites in 2 countries.
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 5 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, United Kingdom. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut Microbiome (time frame: 3-4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07585474, which also lists 1 linked publication.
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 13 May 2026.