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

Study Overview
=================
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.

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

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

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotics (Lab4 probiotics, Cultech, Port Talbot, Wales, UK)
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are assigned into either supplement or placebo intervention groups, in a pair-matched, double-blind, placebo controlled manner.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic Supplementation Arm<br>This group will receive the probiotic supplement for 4-weeks prior to their ironman race performance. | Dietary Supplement: Probiotics (Lab4 probiotics, Cultech, Port Talbot, Wales, UK)<br>* The intervention is a unique blend of probiotic cultures from a well-established manufacturer.<br>* Other names: Lab4 Probiotics, Cultech, Port Talbot, Wales, UK;|
| Placebo Comparator: Placebo Arm<br>This group will receive the placebo capsules for 4-weeks prior to their ironman race performance. | Dietary Supplement: Placebo<br>* Placebo Tablets<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composition of the gut microbiome | This will assess the bacterial content in the gut of the participants, performed using shotgun metagenomic sequencing | 4-weeks | 
| Gastrointestinal symptoms during training and competition | This will be the subjective assessment of any gastrointestinal symptoms experienced during training and competition, from a previously validated questionnaire | 8-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Training volume and intensity | This will be a quantification of the amount of training completed in the 8 weeks leading up to the race, via questionnaire. | 8-weeks | 
| Perceived stress | This will be the subjective assessment of how stressed participants are in the 8 weeks leading up to competition, via questionnaire. | 8-weeks | 
| Quality of sleep | This will be a subjective assessment of how well-rested the participants are in the 8 weeks leading up to competition, via questionnaire. | 8-weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Probiotics, Endurance Exercise, Triathlon, GI Disturbance, Gut Microbiome