Detection of bowel disease using cells from the colon

Background and study aims
The purpose of this study is to examine the differences between cells which are naturally shed from the bowel in patients with and without bowel disease. Origin Sciences Ltd has developed a device to collect these cells. It is hoped that by measuring the total amount of genetic material (DNA) in the cells, we can determine whether there is any disease of the bowel which may explain your change in bowel habit and stomach pains, and hence avoid any further invasive tests such as endoscopy (camera tests).
Who can participate?
You have been chosen because you require investigation of your bowel symptoms and may have bowel disease.
What does the study involve?
If you take part in this study, there will be no change to the investigation or any treatment you undergo for your bowel problem. As part of your normal investigation the doctor will examine your back passage (rectal examination). In this study we would in addition use a small balloon to collect cells from the rectum (lower bowel) during the examination of your back passage. This will only involve a few additional seconds compared to your normal management and will be done at the same time as the examination of the back passage. The total time for the whole examination is about 30 seconds. The amount of discomfort is minimal and less than that of a rectal examination as the balloon is soft and only 1 cm in diameter. The balloon is only inflated for ten seconds. The cells from the surface of the balloon will then be immersed in a fixative (preservation) solution. This preservation fluid ensures little or no loss of cells. The fluid is then taken to the laboratory in Cambridge (Origin Sciences Ltd) where it is processed and analysed. The samples will be looked at to see the total amount of genetic content (DNA). In previous studies we have found that an increase in the amount of DNA that is shed is associated with bowel disease. The samples will also be stored for further analysis to look at new markers in the future which may help in the early diagnosis of bowel inflammation. These markers will have no immediate effect to you or your family and would have to be tested in clinical trials before they can be shown to be reliable.