The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Trial ID
ACTRN12606000115538
Ethics application status
Approved
Date submitted
23/03/2006
Date registered
31/03/2006
Date last updated
14/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Synbiotics in humans on biomarkers of risk for colorectal cancer (CRC)
Scientific title
The potential of synbiotic combination of probiotic bacteria and resistant starch to improve bowel health and reduce risk of colon cancer in humans
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bowel cancer 1080 0
Condition category
Condition code
Cancer 1160 1160 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to test the capacity of a synbiotic (Hi-maize resistant starch + Bifidobacteria) administered in the diet to humans for improving the biomarkers associated with bowel health and reducing the potential risk of colorectal cancer.
We will enlist 20 people in a random cross over design with an initial wash out period of 4 weeks (with no consumption of 'over the counter' products of Resistant Starch or Bifidobacteria) followed by three treatment phases, using the following variables:
Synbiotic – resistant starch (RS) + Bifidobacteria. 4 wks
Probiotic only – Bifidobacteria. 4 wks
Prebiotic only - resistant starch. 4 wks
Comparator / control treatment
No control arms, only 4 intervention arms
Control group
Active

Outcomes
Primary outcome [1] 1563 0
Rectal epithelium: Histological analysis of rectal epithelial which includes proliferation, apoptosis, cellularity, DNA adducts, MGMTase activity & DNA methylation.
Timepoint [1] 1563 0
Rectal pinch biopsy will be taken at the end (fourth week) of the initial wash out phase and during the fourth week of each intervention (treatment phase).
Primary outcome [2] 1564 0
Plasma: Measurement of short chain fatty acids (acetate, propionate and butyrate), blood DNA & serum cytokines.
Timepoint [2] 1564 0
Blood samples will be taken at the end (fourth week) of the initial wash out phase and during the fourth week of each intervention (treatment phase).
Primary outcome [3] 1565 0
Faeces: 24 hour faecal samples for measures including carbohydrate fermentation products (short chain fatty acids), & microflora profile.
Timepoint [3] 1565 0
faecal specimens will be taken at the end (fourth week) of the initial wash out phase and during the fourth week of each intervention (treatment phase).
Secondary outcome [1] 2817 0
Faeces:
24 hour faecal samples: Measures include: Faecal bulk, pH, protein fermentation products (N-nitrosamines, phenols, cresols).
Timepoint [1] 2817 0
Faecal specimens will be taken during the (fourth week) of the initial wash out phase and during the fourth week of each intervention (treatment phase).

Eligibility
Key inclusion criteria
Healthy, with no active bowel disease, or with a previous history of adenoma removal.
Minimum age
21 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Evidence of any active mucosal bowel disease, eg colitis, or of malabsorption.Intolerance to high-fibre foods. Any perceived contraindication to consumption of the test products.

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)
Allocation code will be assigned by numbered containers & sachets.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using randomised table created by a computer software program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
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] 1268 0
Commercial sector/Industry
Name [1] 1268 0
Imperial Chemical Industries PLC
Address [1] 1268 0
20 Manchester Square
London W1U 3AN England
Country [1] 1268 0
United Kingdom
Primary sponsor type
Individual
Name
Professor Graeme Young MD, FRACP
Address
Department of Gastroenterology
Flinders Medical Centre
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 1123 0
Commercial sector/Industry
Name [1] 1123 0
Imperial Chemical Industries PLC
Address [1] 1123 0
20 Manchester Square
London W1U 3AN England
Country [1] 1123 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2599 0
Flinders Medical Centre
Ethics committee address [1] 2599 0
Bedford Park Adelaide SA 5042
Ethics committee country [1] 2599 0
Australia
Date submitted for ethics approval [1] 2599 0
Approval date [1] 2599 0
28/11/2005
Ethics approval number [1] 2599 0
28/056

Summary
Brief summary
This study will explore the potential of synbiotic combination of probiotic bacteria and resistant starch (RS) to improve health and reduce the risk of colon cancer. Participants will be asked to include in their diet either resistant starch or a probiotic or a combination of the two.
Markers of the health value of these dietary agents will then be examined in samples of faeces, blood and samples taken from the lining of the bowel wall.
Since the greatest risk of CRC is due to lifestyle (in particular diet) rather than genetic predisposition (family/hereditary bias), defining the disease mechanism and finding ways to prevent its occurrence are of significant importance.
The proposed study will help provide valuable information on how resistant starch can be used to improve colon health, provide data on the prebiotic use of resistant starch and detailed information on a “synbiotic formulation” that is already on the market.
The study participants (subjects) and the data analyst will be blinded.
The probiotic bacteria will be in the form of boxes of capsules labelled - B
The resistant starch will be in powder form in sachets labelled - A
The combination will be A + B
The resistant starch placebo will be labelled - C
The placebo probiotic will be labelled - D
Example: Pt 1 will be allocated with First 4 weeks A+B, then A and then final 4 weeks B
Their boxes and sachets will be labelled A+B, A+D & B+C respectively.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35538 0
Address 35538 0
Country 35538 0
Phone 35538 0
Fax 35538 0
Email 35538 0
Contact person for public queries
Name 10139 0
Ms Jane Upton
Address 10139 0
Department of Gastroenterology
Flinders Medical Centre
Bedford Park SA 5042
Country 10139 0
Australia
Phone 10139 0
+61 8 82046071
Fax 10139 0
+61 8 82046330
Email 10139 0
jane.upton@fmc.sa.gov.au
Contact person for scientific queries
Name 1067 0
Dr Richard Le Leu
Address 1067 0
Department of Gastroenterology
Flinders University
Flinders Medical Centre
Bedford Park SA 5042
Country 1067 0
Australia
Phone 1067 0
+61 8 82045170
Fax 1067 0
+61 8 82043943
Email 1067 0
Richard.Leleu@flinders.edu.au