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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.
Scientific title
Comparing Digestion 1-2-3-4 with acacia gum on gut bacteria and indices of immunity in physically active male adults
Secondary ID [1] 262753 0
Nil
Universal Trial Number (UTN)
U1111-1123-3365
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal illness 270463 0
Upper respiratory tract illness 270464 0
Condition category
Condition code
Alternative and Complementary Medicine 270613 270613 0 0
Other alternative and complementary medicine
Inflammatory and Immune System 270615 270615 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 267096 0
Treatment: Other
Intervention code [2] 267097 0
Prevention
Comparator / control treatment
Active control: 3 capsules daily with each capsule containing 116 mg acacia powder for four weeks.
Control group
Active

Outcomes
Primary outcome [1] 269349 0
Recovery of faecal lactobacillus paracasei measured denaturing gradient gel electrophoresis and quantitative polymerase chain reaction.
Timepoint [1] 269349 0
pre supplementation and post supplementation.
Primary outcome [2] 269350 0
Faecal recovery of Lactobacillus rhamnosus measured via denaturing gradient gel electrophoresis and quantitative polymerase chain reaction.
Timepoint [2] 269350 0
Pre and post supplementation
Secondary outcome [1] 279427 0
Faecal recovery of Bifidobacterium lactis measured pre supplementation and post supplementation via denaturing gradient gel electrophoresis and quantitative polymerase chain reaction.
Timepoint [1] 279427 0
pre supplementation and post supplementation.
Secondary outcome [2] 279428 0
Faecal recovery of Lactobacillus species measured via denaturing gradient gel electrophoresis and quantitative polymerase chain reaction.
Timepoint [2] 279428 0
pre supplementation and post supplementation.
Secondary outcome [3] 279429 0
Faecal recovery of Lactobacillus acidophilus measured via denaturing gradient gel electrophoresis and quantitative polymerase chain reaction.
Timepoint [3] 279429 0
pre supplementation and post supplementation.
Secondary outcome [4] 279430 0
Faecal recovery of escherichia coli measured via denaturing gradient gel electrophoresis and quantitative polymerase chain reaction.
Timepoint [4] 279430 0
pre supplementation and post supplementation.
Secondary outcome [5] 279431 0
Interleukin 12(P70) measured by microarray
Timepoint [5] 279431 0
pre supplementation and post supplementation.
Secondary outcome [6] 279432 0
Interferon gamma measured by microarray
Timepoint [6] 279432 0
pre supplementation and post supplementation.
Secondary outcome [7] 279433 0
Interleukin 16 measured by microarray
Timepoint [7] 279433 0
pre supplementation and post supplementation.
Secondary outcome [8] 279434 0
Interleukin 18 measured by microarray
Timepoint [8] 279434 0
Pre and post supplementation
Secondary outcome [9] 279435 0
Salivary lactoferrin measured by commercial (Calbiochem) enzyme linked immunosorbant assay
Timepoint [9] 279435 0
Pre and post supplementation
Secondary outcome [10] 279436 0
Urinary lactulose and mannitol measured by high performance liquid chromatography.
Timepoint [10] 279436 0
Pre and post supplementation.

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.
Minimum age
18 Years
Maximum age
55 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals outside of the age or VO2max range, taking immunomodulating medications, asthmatics and individuals with irritable bowel symptoms.

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)
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.
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.
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] 267576 0
Government body
Name [1] 267576 0
Australian Institute of Sport
Address [1] 267576 0
C/- Nicholas West
PO Box 176
Belconnen ACT 2617
Country [1] 267576 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Probiotec Pharma Pty Ltd
Address
83 Cherry Lane
Laverton North
Melbourne, Victoria, 3026
Country
Australia
Secondary sponsor category [1] 266610 0
Government body
Name [1] 266610 0
Australian Institute of Sport
Address [1] 266610 0
C/- Nicholas West
PO Box 176
Belconnen ACT 2617
Country [1] 266610 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269530 0
Australian Institute of Sport Human Research Ethics Committee
Ethics committee address [1] 269530 0
C/- Ms Helene Kay
PO Box 176
Belconnen ACT 2614
Ethics committee country [1] 269530 0
Australia
Date submitted for ethics approval [1] 269530 0
Approval date [1] 269530 0
23/08/2007
Ethics approval number [1] 269530 0
20070804

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.
Trial website
Nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32961 0
Address 32961 0
Country 32961 0
Phone 32961 0
Fax 32961 0
Email 32961 0
Contact person for public queries
Name 16208 0
Nicholas West
Address 16208 0
C/- Sports Science Sport Medicine
Australian Institute of Sport
PO Box 176
Belconnen ACT 2617
Country 16208 0
Australia
Phone 16208 0
+61262147340
Fax 16208 0
Email 16208 0
nicholas.west@ausport.gov.au
Contact person for scientific queries
Name 7136 0
Nicholas West
Address 7136 0
C/- Sports Science Sport Medicine
PO Box 176
Australian Institute of Sport
Belconnen ACT 2617
Country 7136 0
Australia
Phone 7136 0
+61262147340
Fax 7136 0
Email 7136 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