Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000130965
Ethics application status
Approved
Date submitted
24/03/2010
Date registered
4/02/2011
Date last updated
4/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the efficacy of probiotic supplements on illness and immunity in healthy active individuals
Scientific title
Randomized placebo-controlled clinical trial assessing the effect of two probiotic supplements on upper respiratory tract and gastrointestinal illness during a winter period in healthy physically active adult subjects.
Secondary ID [1] 253133 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper respiratory tract illness 257029 0
gastrointestinal symptoms 258691 0
colonization of antibiotic-resistant Escherichia coli 258692 0
Condition category
Condition code
Infection 257187 257187 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Probiotic 1: Lactobacillus spp. and Bifidobacterium spp. at total of 1x10E10 (50:50) per 1g sacchet taken daily mixed into 20-50ml of non-alcoholic beverage during 5 winter months

Probiotic 2: Bifidobacterium spp. at 2x10E10 taken daily per 1g sacchet taken daily mixed into 20-50ml of non-alcoholic beverage during 5 winter months.
Intervention code [1] 256201 0
Prevention
Comparator / control treatment
Sucrose placebo supplement 1g taken daily in sachet form during 5 winter months
Control group
Placebo

Outcomes
Primary outcome [1] 258080 0
Primary Outcome: incidence, severity and duration of upper respiratory tract and gastrointestinal (GI) illness. Both outcomes will be measured by the use of online daily self reported illness logs. Participants will indicate the type and intensity of symptoms they experience on the log. Logs are checked weekly by the research team and participants contacted to confirm any anomalies.

The data will be analysed using SASS
Timepoint [1] 258080 0
Timepoint: daily during the intervention period
Secondary outcome [1] 263663 0
Secondary Outcome 1: Faecal microbiology
Timepoint [1] 263663 0
Timepoint: Pre and post supplementation
Secondary outcome [2] 263668 0
Secondary Outcome 2: Immune function will be analysed by examining peripheral blood mononuclear cell phagocytosis and natural killer cell activity. Data will be analysed with SASS
Timepoint [2] 263668 0
Pre and post intervention
Secondary outcome [3] 263669 0
Secondary Outcome 3: Colonization of antibiotic resistant Escherichia coli (E. coli). Samples will be cultured with antibiotic broths and incubated on agar plates. Data will be analysed by SASS.
Timepoint [3] 263669 0
Pre and post intervention
Secondary outcome [4] 263670 0
Secondary Outcome 4: Resilience. Participants will complete the Connor-Davidson Resilience and the data will be analysed in SASS.
Timepoint [4] 263670 0
questionnaire pre and post intervention
Secondary outcome [5] 263671 0
Secondary Outcome 5: Use of medications.
Timepoint [5] 263671 0
Daily self-report daily during the intervention period

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
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
All participants will be required to declare their use of dietary and/or ergogenic aids that may influence underlying immune function and/or exercise performance. All participants on immuno-modulatory medications will be excluded, including those on steroid based anti-asthma treatments. Subjects who have been on antibiotic treatments in the previous month will also be excluded. A daily illness log will be used to monitor training, health status, diet, use of supplements and other therapeutic agents. Subjects with any symptoms of gastrointestinal disease, such as Crohn’s disease, coelic disease and so on will also be excluded.

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 will be 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 will be age and sex matched and blinded to their treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be randomised using a computer generated, blocked random-allocation sequence by an independent third party not associated with the study
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
29/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2636 0
2600-2900

Funding & Sponsors
Funding source category [1] 256700 0
Commercial sector/Industry
Name [1] 256700 0
Danisco Finland
Country [1] 256700 0
Finland
Primary sponsor type
Commercial sector/Industry
Name
Danisco Finland
Address
Danisco Finland Oy, Sokeritehtaantie 20, 02460 Kantvik, Finland
Country
Finland
Secondary sponsor category [1] 255987 0
None
Name [1] 255987 0
Address [1] 255987 0
Country [1] 255987 0
Other collaborator category [1] 1164 0
University
Name [1] 1164 0
Griffith University
Address [1] 1164 0
Kessels Road, Nathan, Queensland 4222
Country [1] 1164 0
Australia
Other collaborator category [2] 1165 0
Other Collaborative groups
Name [2] 1165 0
Australian Sports Commission / Australian Institute of Sport
Address [2] 1165 0
PO Box 176
Belconnen ACT 2602
Country [2] 1165 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258717 0
Australian Institute of Sport Human Research Ethics Committee
Ethics committee address [1] 258717 0
PO Box 176 Belconnen ACT 2616
Ethics committee country [1] 258717 0
Australia
Date submitted for ethics approval [1] 258717 0
Approval date [1] 258717 0
16/02/2010
Ethics approval number [1] 258717 0
200100101

Summary
Brief summary
There is increasing interest in the use of nutritional supplements to improve health and wellbeing. Probiotics are proposed to boost immunity and reduce susceptibility to infection. Common infections, such as URTI, are a significant burden on the community. There is growing body of evidence that probiotic supplementation may reduce the prevalence of URTI and GI illness in the general population.

Hypothesis: That a probiotic supplement will enhance immunity and ameliorate the heightened susceptibility to upper respiratory tract illness (URTI) and gastrointestinal tract illness in active well-trained community individuals.
Trial website
http://www.ausport.gov.au/ais/sssm/physiology/research/probiotic_study
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30978 0
Address 30978 0
Country 30978 0
Phone 30978 0
Fax 30978 0
Email 30978 0
Contact person for public queries
Name 14225 0
Nicholas West
Address 14225 0
Australian Institute of Sport
PO Box 176
Belconnen ACT 2617
Country 14225 0
Australia
Phone 14225 0
+61 2 6247 1660
Fax 14225 0
Email 14225 0
[email protected]
Contact person for scientific queries
Name 5153 0
Nicholas West
Address 5153 0
Australian Institute of Sport
PO Box 176
Belconnen ACT 2617
Country 5153 0
Australia
Phone 5153 0
+61 2 6247 1660
Fax 5153 0
Email 5153 0
[email protected]

No information has been provided regarding IPD availability


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
Dimensions AIProbiotic supplementation for respiratory and gastrointestinal illness symptoms in healthy physically active individuals2013https://doi.org/10.1016/j.clnu.2013.10.002
N.B. These documents automatically identified may not have been verified by the study sponsor.