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Trial registered on ANZCTR
Registration number
ACTRN12611000807954
Ethics application status
Approved
Date submitted
1/08/2011
Date registered
1/08/2011
Date last updated
1/08/2011
Type of registration
Retrospectively registered
Titles & IDs
Public title
Synbiotic supplementation: effects on faecal microbiota and immunity in physically active individuals.
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Scientific title
Comparing Digestion 1-2-3-4 with acacia gum on gut bacteria and indices of immunity in physically active male adults
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Secondary ID [1]
262753
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Nil
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Universal Trial Number (UTN)
U1111-1123-3365
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal illness
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Upper respiratory tract illness
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Condition category
Condition code
Alternative and Complementary Medicine
270613
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0
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Other alternative and complementary medicine
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Inflammatory and Immune System
270615
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0
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Normal development and function of the immune system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Experimental intervention: 3 capsules daily for four weeks of Digestion 1-2-3-4, which contains per capsule 200mg glycomax immunoglobulin, 50mg of lactoferrin, 4.6x10e8 Lactobacillus paracasei, 6x10e8 Bifidobacterium Lactis, 4.6x10e8 Lactobacillus acidophilus, 4.6x10e8 Lactobacillus rhamnosus, 90mg Raftiline and 10mg Raftilose GR.
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Intervention code [1]
267096
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Treatment: Other
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Intervention code [2]
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Prevention
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Comparator / control treatment
Active control: 3 capsules daily with each capsule containing 116 mg acacia powder for four weeks.
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Control group
Active
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Outcomes
Primary outcome [1]
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Recovery of faecal lactobacillus paracasei measured denaturing gradient gel electrophoresis and quantitative polymerase chain reaction.
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Assessment method [1]
269349
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Timepoint [1]
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pre supplementation and post supplementation.
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Primary outcome [2]
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Faecal recovery of Lactobacillus rhamnosus measured via denaturing gradient gel electrophoresis and quantitative polymerase chain reaction.
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Assessment method [2]
269350
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Timepoint [2]
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Pre and post supplementation
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Secondary outcome [1]
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Faecal recovery of Bifidobacterium lactis measured pre supplementation and post supplementation via denaturing gradient gel electrophoresis and quantitative polymerase chain reaction.
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Assessment method [1]
279427
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Timepoint [1]
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pre supplementation and post supplementation.
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Secondary outcome [2]
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Faecal recovery of Lactobacillus species measured via denaturing gradient gel electrophoresis and quantitative polymerase chain reaction.
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Assessment method [2]
279428
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Timepoint [2]
279428
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pre supplementation and post supplementation.
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Secondary outcome [3]
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Faecal recovery of Lactobacillus acidophilus measured via denaturing gradient gel electrophoresis and quantitative polymerase chain reaction.
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Assessment method [3]
279429
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Timepoint [3]
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pre supplementation and post supplementation.
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Secondary outcome [4]
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Faecal recovery of escherichia coli measured via denaturing gradient gel electrophoresis and quantitative polymerase chain reaction.
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Assessment method [4]
279430
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Timepoint [4]
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pre supplementation and post supplementation.
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Secondary outcome [5]
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Interleukin 12(P70) measured by microarray
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Assessment method [5]
279431
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Timepoint [5]
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pre supplementation and post supplementation.
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Secondary outcome [6]
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Interferon gamma measured by microarray
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Assessment method [6]
279432
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Timepoint [6]
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pre supplementation and post supplementation.
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Secondary outcome [7]
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Interleukin 16 measured by microarray
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Assessment method [7]
279433
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Timepoint [7]
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pre supplementation and post supplementation.
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Secondary outcome [8]
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Interleukin 18 measured by microarray
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Assessment method [8]
279434
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Timepoint [8]
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Pre and post supplementation
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Secondary outcome [9]
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Salivary lactoferrin measured by commercial (Calbiochem) enzyme linked immunosorbant assay
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Assessment method [9]
279435
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Timepoint [9]
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Pre and post supplementation
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Secondary outcome [10]
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Urinary lactulose and mannitol measured by high performance liquid chromatography.
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Assessment method [10]
279436
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Timepoint [10]
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Pre and post supplementation.
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Eligibility
Key inclusion criteria
Undertaking a minimum 3 exercise sessions per week, have a minimum VO2max (maximum oxygen uptake) of 45ml/kg/min and not have taken antibiotics for a period of one month before the start of supplementation.
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Individuals outside of the age or VO2max range, taking immunomodulating medications, asthmatics and individuals with irritable bowel symptoms.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects were enrolled after meeting the key inclusion and exclusion criteria and undertaking the VO2max test. The study was double blinded with treatments being identical in packaging, taste and colour. The allocation sequence was held by an independent physician until completion of the outcome assessment.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation was undertaken by an independent researcher using a computer generated random allocation spreadsheet.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
16/02/2008
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
45
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Australian Institute of Sport
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Address [1]
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C/- Nicholas West
PO Box 176
Belconnen ACT 2617
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Country [1]
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Probiotec Pharma Pty Ltd
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Address
83 Cherry Lane
Laverton North
Melbourne, Victoria, 3026
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Country
Australia
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Secondary sponsor category [1]
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Government body
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Name [1]
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Australian Institute of Sport
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Address [1]
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C/- Nicholas West
PO Box 176
Belconnen ACT 2617
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Country [1]
266610
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
269530
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Australian Institute of Sport Human Research Ethics Committee
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Ethics committee address [1]
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C/- Ms Helene Kay
PO Box 176
Belconnen ACT 2614
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
269530
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Approval date [1]
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23/08/2007
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Ethics approval number [1]
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20070804
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Summary
Brief summary
The aim of this study is to compare a synbiotic supplement containing pre- and probiotics, bovine lactoferrin and bovine immunoglobulines with acacia gum on gut bacteria and indices of immunity. The study will provide consumers with evidence based advice on the use of a synbiotic supplement.
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Trial website
Nil
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
32961
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Address
32961
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Country
32961
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Phone
32961
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Fax
32961
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Email
32961
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Contact person for public queries
Name
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Nicholas West
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Address
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C/- Sports Science Sport Medicine
Australian Institute of Sport
PO Box 176
Belconnen ACT 2617
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Country
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Australia
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Phone
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+61262147340
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Nicholas West
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Address
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C/- Sports Science Sport Medicine
PO Box 176
Australian Institute of Sport
Belconnen ACT 2617
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Country
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Australia
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Phone
7136
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+61262147340
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Fax
7136
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Email
7136
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[email protected]
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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
No additional documents have been identified.
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