NCT07585474

Brief 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 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

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Jul 2025

Geographic Reach
2 countries

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Jul 2025Aug 2026

First Submitted

Initial submission to the registry

July 21, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

July 25, 2025

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2025

Completed
9 months until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2026

Expected
Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

24 days

First QC Date

July 21, 2025

Last Update Submit

May 8, 2026

Conditions

Keywords

Gut microbiomeProbioticsPre-SeasonFootballLong-HaulTravel

Outcome Measures

Primary Outcomes (1)

  • 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.

    3-4 weeks

Secondary Outcomes (1)

  • Salivary IgA

    3-4 weeks

Study Arms (2)

Active Treatment Group

EXPERIMENTAL

All participants receive probiotic once orally for 3-4 weeks

Drug: Probiotic Capsule

Placebo

PLACEBO COMPARATOR

Participants receive matching placebo orally once daily for 3-4 weeks

Drug: Placebo

Interventions

Probiotic capsule administered orally once daily for 3 weeks

Active Treatment Group

Placebo tablet, identical in appearance to probiotic, administered orally once daily for 3-4 weeks.

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

1 Hotel Nashville

Nashville, Tennessee, 37203, United States

Location

Bodymoor Heath

Tamworth, West Midlands, B78 2BB, United Kingdom

Location

Related Publications (1)

  • 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

    BACKGROUND

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • George Davis, Masters

    Sheffield Hallam University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Parallel Randomised Control Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

July 21, 2025

First Posted

May 13, 2026

Study Start

July 25, 2025

Primary Completion

August 18, 2025

Study Completion (Estimated)

August 15, 2026

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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.

Locations