Abstract
A protocol was made for an interventional randomized controlled trial for prevention of colorectal cancer. The subjects were 300 patients with familial adenomatous polyposis from collaborative multiple institutions. Four regimens were formulated for prevention of colorectal cancer. Regimen A was dietary guidance, wheat bran biscuits and decaffeinated green tea extract tables, regimen B was dietary guidance, wheat bran biscuits and non-function tablets, regimen C was dietary guidance and decaffeinated green tea extract tables, regimen D was dietary guidance and non-function tablets. The main end point of the trial is number and size of colorectal adenoma after 2 years. Recruiting of subjects was started in September, 2000. The trial will be completed in March, 2004.
