Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000555459
Ethics application status
Approved
Date submitted
11/04/2016
Date registered
29/04/2016
Date last updated
18/06/2021
Date data sharing statement initially provided
18/06/2021
Date results provided
18/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of probiotics for reducing the incidence and severity of illness in elite team sport athletes
Scientific title
Efficacy of probiotics for reducing the incidence and severity of illness in elite team sport athletes
Secondary ID [1] 288971 0
NIL KNOWN
Universal Trial Number (UTN)
U1111-1181-7666
Trial acronym
Pro-elite
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gastrointestinal infection prophylaxis 298360 0
general health and wellbeing 298361 0
respiratory infection prophylaxis 298362 0
Condition category
Condition code
Alternative and Complementary Medicine 298469 298469 0 0
Other alternative and complementary medicine
Infection 298531 298531 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A proprietary blend of probiotic bacteria capsules (twice daily with food) and yeast capsules (twice daily with food) or placebo will be given to elite team athletes for 7 months.
At the end of the trial all remaining capsules will be returned and counted as a means of measuring compliance. In addition, the head trainer will provide reminders regarding taking the trial medicine to improve compliance
The details of the probiotic and yeasts are commercial and in confidence and listed privately with the ANZCTR
Intervention code [1] 294458 0
Prevention
Intervention code [2] 294460 0
Treatment: Other
Comparator / control treatment
Placebo controlled in same age-matched elite team athletes. The placebo will contained corn starch.
Control group
Placebo

Outcomes
Primary outcome [1] 297959 0
This is a composite primary outcome i.e.to identify if probiotics ingestion is effective in reducing the number and severity of upper respiratory tract infections.
The incidence of respiratory infections will be recorded by the team doctor and the severity recorded as mild moderate or severe.
Timepoint [1] 297959 0
5 months prior to baseline enrolment and again at 6 months after intervention has commenced.
Primary outcome [2] 298023 0
composite of number and severity of gastrointestinal infections assessed and recorded by the team doctor. The team doctor will record the number of gastrointestinal infections and rate the severity of the symptoms, mild moderate or severe
Timepoint [2] 298023 0
from 5 months before baseline enrolment to 6 months after intervention has commenced.
Secondary outcome [1] 322764 0

Salivary biomarkers of immunity and stress - sIgA, cortisol, alpha-amylase and testosterone
Timepoint [1] 322764 0
Assessed twice weekly for six months from commencing intervention for 7 months
Secondary outcome [2] 322983 0
The Daily Analysis of Life Demands for Athletes (DALDA) on a weekly basis.
Timepoint [2] 322983 0
Weekly from commencement of intervention for 6 months
Secondary outcome [3] 322987 0
A composite secondary outcome will include standard wellness information (sleep quality and quantity, muscle soreness). This will be measured through administering The Standard Wellness Questionnaire weekly
Timepoint [3] 322987 0
weekly from commencement of intervention for 6 months

Eligibility
Key inclusion criteria
Elite team athletes that are member of the Australian Rugby Union who travel for intensive competition periods. We do not want to disclose to the public or competitors which ARU team is participating in this trial.
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any player not in good medical health or with any diagnosed medical condition of the immune or gastrointestinal system.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The holder of the allocation schedule will be "off-site" and have no contact with the participants. They will be contactable through the study if concealment needs to be broken..
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
No sample size calculations have been performed as the number of participants is entirely dependent on the number of players in the team. Salivary biomarkers results - their 90% confidence limits will be estimated with a spreadsheet via the unequal-variances t statistic computed for change scores between baseline (pre) - and post-tests of the two groups. Each subject’s change score will be expressed as a percentage of baseline score by analysis of log-transformed values, in order to reduce bias arising from non-uniformity of error. Comparison of the frequency of illness measures recorded during probiotic and placebo treatments will be conducted using X2 analysis, and illness severity scores will be compared using a Mann–Whitney U test for non-parametric measures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/05/2016
Actual
28/05/2016
Date of last participant enrolment
Anticipated
29/05/2016
Actual
29/05/2016
Date of last data collection
Anticipated
Actual
20/06/2017
Sample size
Target
38
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 293331 0
Commercial sector/Industry
Name [1] 293331 0
FIT Bioceuticals
Country [1] 293331 0
Australia
Primary sponsor type
University
Name
The University of Canberra
Address
University Drive, Canberra Australian Capital Territory 2617
Country
Australia
Secondary sponsor category [1] 292150 0
Commercial sector/Industry
Name [1] 292150 0
The Australian Rugby Union
Address [1] 292150 0
29-57 Christie St, St Leonards NSW 2065
Country [1] 292150 0
Australia
Other collaborator category [1] 278939 0
University
Name [1] 278939 0
The University of Sydney
Address [1] 278939 0
Camperdown Campus Sydney, NSW 2006
Country [1] 278939 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294800 0
ACT Health Human Research Ethics Committee -The Unversity of Canberra
Ethics committee address [1] 294800 0
Ethics committee country [1] 294800 0
Date submitted for ethics approval [1] 294800 0
23/03/2016
Approval date [1] 294800 0
07/04/2016
Ethics approval number [1] 294800 0
HREC 16-49

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65086 0
Dr Kate Pumpa
Address 65086 0
Discipline of Exercise and Sport Science, Faculty of Health

UC Research Institute for Sport and Exercise
University Drive,
University of Canberra, ACT 2601
Country 65086 0
Australia
Phone 65086 0
+61 2 6201 2936
Fax 65086 0
Email 65086 0
[email protected]
Contact person for public queries
Name 65087 0
Joanna Harnett
Address 65087 0
Faculty of Pharmacy
Building A15
The University of Sydney
Sydney
NSW
2006
Country 65087 0
Australia
Phone 65087 0
+612 9351 7009
Fax 65087 0
Email 65087 0
[email protected]
Contact person for scientific queries
Name 65088 0
Joanna Harnett
Address 65088 0
Faculty of Pharmacy
Building A15
The University of Sydney
Sydney
NSW
2006
Country 65088 0
Australia
Phone 65088 0
+612 9351 7009
Fax 65088 0
Email 65088 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA novel role of probiotics in improving host defence of elite rugby union athlete: A double blind randomised controlled trial.2019https://dx.doi.org/10.1016/j.jsams.2019.03.013
N.B. These documents automatically identified may not have been verified by the study sponsor.