ANZCTR - Registration

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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]

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

general health and wellbeing

respiratory infection prophylaxis

Condition category

Condition code

Alternative and Complementary Medicine

Other alternative and complementary medicine

Infection

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]

Prevention

Intervention code [2]

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]

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]

5 months prior to baseline enrolment and again at 6 months after intervention has commenced.

Primary outcome [2]

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]

from 5 months before baseline enrolment to 6 months after intervention has commenced.

Secondary outcome [1]

Salivary biomarkers of immunity and stress - sIgA, cortisol, alpha-amylase and testosterone

Timepoint [1]

Assessed twice weekly for six months from commencing intervention for 7 months

Secondary outcome [2]

The Daily Analysis of Life Demands for Athletes (DALDA) on a weekly basis.

Timepoint [2]

Weekly from commencement of intervention for 6 months

Secondary outcome [3]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

FIT Bioceuticals

Address [1]

6/37-41 O'Riordan Street, Alexandria New South Wales 2015

Country [1]

Australia

Primary sponsor type

University

Name

The University of Canberra

Address

University Drive, Canberra Australian Capital Territory 2617

Country

Australia

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

The Australian Rugby Union

Address [1]

29-57 Christie St, St Leonards NSW 2065

Country [1]

Australia

Other collaborator category [1]

University

Name [1]

The University of Sydney

Address [1]

Camperdown Campus Sydney, NSW 2006

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

ACT Health Human Research Ethics Committee -The Unversity of Canberra

Ethics committee address [1]

The University of Canberra
University Dr, Bruce ACT 2617
Canberra ACT

Ethics committee country [1]

Date submitted for ethics approval [1]

23/03/2016

Approval date [1]

07/04/2016

Ethics approval number [1]

HREC 16-49

Summary

Brief summary

Of interest to this study is the role specific species and strains of probiotics could play in reducing the incidence and/or severity of respiratory and gastrointestinal symptoms infections in elite team sport athletes who travel frequently. The impact of endurance exercise on immune function is well established with a body of research to support that in a significant number of athletes, the physical and mental stress endured by elite athletes can result in an increased susceptibility to gastrointestinal and respiratory infections. Furthermore, a number of trials have investigated the efficacy of supplementing with specific Lactobacilli and Bifidobacteria in reducing respiratory infections.

Trial website

None

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Kate Pumpa

Address

Discipline of Exercise and Sport Science, Faculty of Health

UC Research Institute for Sport and Exercise
University Drive,
University of Canberra, ACT 2601

Country

Australia

Phone

+61 2 6201 2936

Fax

kate.pumpa@canberra.edu.au

Contact person for public queries

Name

Joanna Harnett

Address

Faculty of Pharmacy
Building A15
The University of Sydney
Sydney
NSW
2006

Country

Australia

Phone

+612 9351 7009

Fax

joanna.harnett@sydney.edu.au

Contact person for scientific queries

Name

Joanna Harnett

Address

Faculty of Pharmacy
Building A15
The University of Sydney
Sydney
NSW
2006

Country

Australia

Phone

+612 9351 7009

Fax

joanna.harnett@optusnet.com.au

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

Source	Title	Year of Publication	DOI
Embase	A novel role of probiotics in improving host defence of elite rugby union athlete: A double blind randomised controlled trial.	2019	https://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.

Trial Review

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Documents added manually

Documents added automatically