The effect of Synbiotics in humans on biomarkers of risk for colorectal cancer (CRC)

Interventions: 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
Primary outcome(s): Rectal epithelium: Histological analysis of rectal epithelial which includes proliferation, apoptosis, cellularity, DNA adducts, MGMTase activity & DNA methylation.[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).];Plasma: Measurement of short chain fatty acids (acetate, propionate and butyrate), blood DNA & serum cytokines.[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).];Faeces: 24 hour faecal samples for measures including carbohydrate fermentation products (short chain fatty acids), & microflora profile.[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).]
Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Crossover;Type of endpoint: Efficacy