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Effect of Probiotics on Endurance Athletes' Microbiome at Rest and Post-race

Effect of Probiotics on Endurance Athletes' Microbiome at Rest and Post-race

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05615961
Enrollment
70
Registered
2022-11-14
Start date
2022-07-01
Completion date
2022-10-10
Last updated
2022-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aerobic Exercise, Athletes, Gastrointestinal Tract Irritation, Gut Microbiome, Gut Microbiota, Probiotics

Keywords

Probiotics, Endurance Exercise, Triathlon, GI Disturbance, Gut Microbiome

Brief summary

This study is intended to investigate the use of probiotics (LAB4 probiotics, Cultech, Port Talbot, Wales, UK) and the effect this has on gastrointestinal symptoms experienced during elite long-distance triathlon (ironman) competition, as well as the composition of the gut bacteria in the athlete. Long-distance triathlon events frequently induce gastrointestinal discomfort due to the duration of the event (8-17 hours), the intensity of the exercise and the ingestion of large amounts of sugars throughout the event. Data will be collected from athletes participating at the Kona ironman World-championships. Participants will supplement with either probiotic tablet, or placebo (sugar-pill) for 4-weeks prior to competition. Athletes will be both male and female age-group athletes from any qualifying age category (age categories are as follows: 18-24; 25-29; 30-34; 35-39; 40-44; 45-49; 50-54; 55-59; 60-64; 65-69; 70-74; 75-79; 80-84). The main investigation of the study will be the occurence/frequency/severity of gastrointestinal symptoms during training and competition between groups.

Detailed description

The study will recruit ironman triathletes who have qualified for the Kona ironman World-championships in Hawaii. Participants will be allocated into either probiotic (Lab4 Probiotics, Cultech, Port Talbot, Wales, UK) or placebo (Maltodextrin) groups, in a double-blind fashion (Blinded by supplement supplier). Those recruited into the study will have their training load and gut symptoms monitored for 8-weeks prior to competition via the completion of online questionnaires (previously validated). Four-weeks prior to competition participants will provide a stool sample for microbiome analysis, they will then proceed to supplement with probiotic or placebo for 4-weeks. 24-h prior to competition they will provide a stool sample as well as providing a sample from the first bowel movement post-race, which will be used for microbiome analysis. Data will be collected for pre-race and raceday nutrition, as well as outcome measures for raceday performance and gastroitestinal symptoms experienced, again via online questionnaire. Stool samples will be analysed by an independent laboratory that specialises in microbiome analysis. Primary outcome measures will be the composition of the gut bacteria and the metabolites (substances produced) of the gut bacteria at baseline, pre-race and post-race. As well as the occurrence (frequency, duration, severity) of gastrointestinal symptoms during training and competition.

Interventions

DIETARY_SUPPLEMENTProbiotics (Lab4 probiotics, Cultech, Port Talbot, Wales, UK)

The intervention is a unique blend of probiotic cultures from a well-established manufacturer.

DIETARY_SUPPLEMENTPlacebo

Placebo Tablets

Sponsors

Georgia Southern University
CollaboratorOTHER
University of Illinois at Chicago
CollaboratorOTHER
Liverpool John Moores University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

The study has been blinded by an impartial third party from the company that has provided both the probiotic supplements and the placebo capsules.

Intervention model description

Participants are assigned into either supplement or placebo intervention groups, in a pair-matched, double-blind, placebo controlled manner.

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

* Aged 18-85 * Qualification for the Kona Ironman World-championships in Hawaii

Exclusion criteria

* Have a current musculoskeletal injury. * Currently unwell with cold or flu * Have been told they have liver disease * Have gastric Ulcer or other gastric/stomach problems * Have a condition/disease of the Gut/bowel. * Have diagnosed uncontrolled asthma * Have kidney problems * Have a chronic connective tissue disorder * Have suffered cerebrovascular disease such as a stroke * Are taking balcofen, methotrexate, tacrolimus and voriconazole, beta-blockers or diuretics drugs

Design outcomes

Primary

MeasureTime frameDescription
Composition of the gut microbiome4-weeksThis will assess the bacterial content in the gut of the participants, performed using shotgun metagenomic sequencing
Gastrointestinal symptoms during training and competition8-weeksThis will be the subjective assessment of any gastrointestinal symptoms experienced during training and competition, from a previously validated questionnaire

Secondary

MeasureTime frameDescription
Training volume and intensity8-weeksThis will be a quantification of the amount of training completed in the 8 weeks leading up to the race, via questionnaire.
Perceived stress8-weeksThis will be the subjective assessment of how stressed participants are in the 8 weeks leading up to competition, via questionnaire.
Quality of sleep8-weeksThis will be a subjective assessment of how well-rested the participants are in the 8 weeks leading up to competition, via questionnaire.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026