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Trial registered on ANZCTR


Registration number
ACTRN12611000006943
Ethics application status
Approved
Date submitted
20/12/2010
Date registered
4/01/2011
Date last updated
4/01/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Probiotics, illness and immunity in athletes
Scientific title
Lactobacillus fermentum supplementation, upper respiratory tract illness and athletes: A randomised controlled placebo trial.
Secondary ID [1] 253320 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper respiratory tract illness 258859 0
Gastrointestinal illness 258860 0
Condition category
Condition code
Infection 258998 258998 0 0
Studies of infection and infectious agents
Alternative and Complementary Medicine 259019 259019 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1 capsule containing 1 billion per day of Lactobacillus fermentum PCC daily for 77 days
Intervention code [1] 257775 0
Prevention
Comparator / control treatment
Placebo: 1 capsule of microcrystalline cellulose daily for 77 days
Control group
Placebo

Outcomes
Primary outcome [1] 259848 0
Upper respiratory tract illness. Subjects report on a range of symptoms (sore throat, sneezing, runny or blocked nose, cough) and indicated severity on a 3-point scale. The severity of symptoms were self-rated as mild, moderate or severe based on the impact of the symptoms on exercise training for that day, with mild symptoms resulting in no change to training, moderate symptoms necessitating a reduction in training volume and/or intensity, and severe symptoms leading to a total cessation of training on that day.
Timepoint [1] 259848 0
Daily: subjects report symptoms (sore throat, coughing, sputum, sneezing, blocked/runny nose) daily for the 77 days of the study
Primary outcome [2] 259849 0
Gastrointestinal illness. Subjects report on a range of symptoms and indicated severity on a 3-point scale. The severity of symptoms were self-rated as mild, moderate or severe based on the impact of the symptoms on exercise training for that day, with mild symptoms resulting in no change to training, moderate symptoms necessitating a reduction in training volume and/or intensity, and severe symptoms leading to a total cessation of training on that day.
Timepoint [2] 259849 0
Daily: subjects report symptoms (diarrhoea, flatulance, rumbles) daily for the 77 days of the study
Primary outcome [3] 259850 0
Cold and flu medication use
Timepoint [3] 259850 0
Daily: subjects report medications used daily for the duration of the study
Secondary outcome [1] 268716 0
Faecal microbiology - quantitation of the dominant bacterial species in stool samples
Timepoint [1] 268716 0
Pre-supplementation (day 0) and post supplementation (days 74-77)
Secondary outcome [2] 268717 0
Salivary immunoglobulin A, lactoferrin and lysozyme
Timepoint [2] 268717 0
Pre-supplementation (day 0) and post supplementation (days 74-77)
Secondary outcome [3] 268718 0
Serum cytokines - IL-1RA, IL-6, Il-10, IFN-gamma, TNF-alpha and GM-CSF
Timepoint [3] 268718 0
Pre and postan exercise test to exhaustion prior (day 0) to and at the end of supplementation (days 74-77) .

Eligibility
Key inclusion criteria
Inclusion to the study will be determined according to physical activity levels with subjects required to be undertaking 3 exercise sessions weekly and a questionnaire to determine subject’s health in the previous month
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Use of immunomodulatory medications, asthma, GI illness

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)
Following consent and the respective entry criteria being met, participants were randomly assigned to a treatment group using a computer generated, blocked random-allocation sequence by an independent third party not associated with the study. Subjects were match on VO2, age andsex and blinded to their treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258240 0
Commercial sector/Industry
Name [1] 258240 0
Christian Hansen A/S
Address [1] 258240 0
Boge Alle 10-12
DK- 2970 Horsholm
Denmark
Country [1] 258240 0
Denmark
Primary sponsor type
Commercial sector/Industry
Name
Probiomics Ltd
Address
Probiomics Limited
Suite G09, 1 Central Avenue
Australian Technology Park
Eveleigh NSW 2015
Australia
Country
Australia
Secondary sponsor category [1] 257410 0
Government body
Name [1] 257410 0
Australian Institute of Sport
Address [1] 257410 0
Po Box 176
Belconnen ACT 2617
Country [1] 257410 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260220 0
Australian Institute of Sport Human Research Ethics Committee
Ethics committee address [1] 260220 0
PO Box 176
Belconnen ACT 2617
Ethics committee country [1] 260220 0
Australia
Date submitted for ethics approval [1] 260220 0
Approval date [1] 260220 0
20/05/2008
Ethics approval number [1] 260220 0
20080203

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

Contacts
Principal investigator
Name 32034 0
Address 32034 0
Country 32034 0
Phone 32034 0
Fax 32034 0
Email 32034 0
Contact person for public queries
Name 15281 0
Nicholas West
Address 15281 0
PO Box 176
Belconnen ACT 2614
Country 15281 0
Australia
Phone 15281 0
+61 2 6214 7340
Fax 15281 0
Email 15281 0
nicholas.west@ausport.gov.au
Contact person for scientific queries
Name 6209 0
Nicholas West
Address 6209 0
PO Box 176
Belconnen ACT 2614
Country 6209 0
Australia
Phone 6209 0
+61 2 6214 7340
Fax 6209 0
Email 6209 0
nicholas.west@ausport.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary