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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 336356
ACTR Number: ACTRN12611000006943
Trial Status: Registered
Date Submitted: 20/12/2010
Date Registered: 4/01/2011
Date Last Updated: 04/01/2011
Registration Type: Retrospective registered

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Public title: Probiotics, illness and immunity in athletes
ANZCTR registration title: Lactobacillus fermentum supplementation, upper respiratory tract illness and athletes: A randomised controlled placebo trial.
Secondary ID:Nil 
UTN:
Trial acronym:

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

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

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Primary outcome 1: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:Daily: subjects report symptoms (sore throat, coughing, sputum, sneezing, blocked/runny nose) daily for the 77 days of the study 
Primary outcome 2: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:Daily: subjects report symptoms (diarrhoea, flatulance, rumbles) daily for the 77 days of the study 
Primary outcome 3:Cold and flu medication use 
Timepoint:Daily: subjects report medications used daily for the duration of the study 
Secondary outcome 1:Faecal microbiology - quantitation of the dominant bacterial species in stool samples 
Timepoint:Pre-supplementation (day 0) and post supplementation (days 74-77) 
Secondary outcome 2:Salivary immunoglobulin A, lactoferrin and lysozyme 
Timepoint:Pre-supplementation (day 0) and post supplementation (days 74-77) 
Secondary outcome 3:Serum cytokines - IL-1RA, IL-6, Il-10, IFN-gamma, TNF-alpha and GM-CSF 
Timepoint:Pre and postan exercise test to exhaustion prior (day 0) to and at the end of supplementation (days 74-77) . 

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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
Healthy volunteers? Yes
Key exclusion criteria: Use of immunomodulatory medications, asthma, GI illness

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Study type: Interventional
Purpose of the study: Prevention
Allocation to intervention: Randomised controlled trial
Describe the 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.
Describe the methods used to generate the sequence in which subjects will be randomised (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 analysing the results/data
Assignment: Parallel
Other design features (specify):
Type of endpoint(s): Efficacy

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Phase Not Applicable
Anticipated or actual date of first participant enrolement: 1/06/2008
Target sample size: 100
Recruitment status: Completed

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Funding source:Commercial sector/Industry 
Name:Christian Hansen A/S 
Address:Boge Alle 10-12
DK- 2970 Horsholm
Denmark 
Country:Denmark 
Primary sponsor: 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:Government funding body e.g. Department of Health 
Name:Australian Institute of Sport 
Address:Po Box 176
Belconnen ACT 2617 
Country:Australia 
Other collaborator: 

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Has the study received approval from at least one ethics committee? Yes
Ethics Committee name:Australian Institute of Sport Human Research Ethics Committee 
Address:PO Box 176
Belconnen ACT 2617 
Country:Australia 
Date of approval:20/05/2008 
HREC Number:20080203 
Countries of recruitment:Australia 
Brief summary:
Trial website:
Presentations / publication list:

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Contact person for public queries
Name: Nicholas West
Address: PO Box 176
Belconnen ACT 2614
Country: Australia
Tel: +61 2 6214 7340
Fax:
Email: nicholas.west@ausport.gov.au

Contact person for scientific queries
Name: Nicholas West
Address: PO Box 176
Belconnen ACT 2614
Country: Australia
Tel: +61 2 6214 7340
Fax:
Email: nicholas.west@ausport.gov.au
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