“I think it’s essential that people keep signing up to these type of trials to push research forward.”
A study to test the effect of a fatty acid on biomarkers of bowel cancer risk
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking to see how substances in the body linked to bowel cancer risk (
Studies looking at whether people develop bowel cancer or not take a long time and look at large numbers of people. It would be useful to find another way of working out the risk of developing cancer, so that trials can be smaller and quicker to carry out.
Researchers in this study have already found several possible substances in the body (biomarkers) linked to bowel cancer risk. They now need to see if these biomarkers will be useful. In this study they will test how these biomarkers respond to a fatty acid called butyrate, which they already know reduces the risk of bowel cancer.
They will give some people different types of indigestible (resistant) starch powder, which is broken down by bacteria in the body into fatty acids including butyrate. Other people will have a dummy powder (a placebo). After people have taken the powder for 50 days, researchers will look at biomarkers in bowel tissue, blood, urine and stool samples from before and after taking the powder. The aim of this study is to look at the impact of resistant starch and the butyrate it helps produce, on biomarkers of bowel cancer risk.
You will not have any direct benefit from taking part in this study, and it is unlikely to change your treatment plan in any way. But the results of the study will help people in the future.
Who can enter
You can enter this study if
- You are under the care of Wansbeck General Hospital or North Tyneside General Hospital
- You are going to have either a camera examination of the large bowel (colonoscopy), or of the lower part of the large bowel (flexible sigmoidoscopy)
- The doctor cannot see any tissue changes during the procedure
- You are between 16 and 85 years of age
You cannot enter this study if
- You have a rare inherited disease that causes lots of non cancerous growths in the bowel (
familial adenomatous polyposis (FAP))
- You have a rare inherited condition called HNPCC (Lynch syndrome) that increases risk of bowel cancer, womb cancer, ovarian cancer and stomach cancer
- You have or have had cancer of the bowel (colorectal cancer)
- You have had surgery to remove part of your bowel
- You have had chemotherapy in the last 6 months
- You are taking aspirin or other non steroidal anti inflammatory drugs (NSAIDs)
- You are taking any other medication that dampens your immune system
- Your doctor found some active
inflammationin your bowel during your bowel examination
- The doctor could not examine all the bowel tissue they needed to
- The doctor found bowel cancer either during the bowel examination or under the microscope in the laboratory
- Part of your bowel tissue tore (perforated) during the examination
- You are taking warfarin or other medication to thin your blood
- You have diabetes
- You have Crohn’s disease
- You have difficulty learning, understanding and remembering information
- You are pregnant
This randomised study will recruit 75 people into 4 groups. Neither you nor your doctor will be able to decide or know which group you are in. This is called a double blind study.
At the start, everyone will give 9 samples of bowel tissue (biopsies) and a urine, blood and stool sample. The team will also take some body measurements.
You will then be given one of 4 types of starch powder to add to food or drink. You take one dose every day, for 50 days.
If you are in group 1, you will have hi-maize.
If you are in group 2, you will have polydextrose.
If you are in group 3, you will have hi-maize and polydextrose.
If you are in group 4, you will have a dummy starch powder (placebo).
When you have completed your 50 doses of starch, you have another camera examination of the bowel called a rigid sigmoidoscopy. This is similar to a flexible sigmoidoscopy, but the tube is shorter and does not bend. During this procedure, the team will take 9 samples of bowel tissue (biopsies).
You will also give another blood, urine and stool sample and another set of body measurements.
After the study you continue to see your regular specialist in the same way as you did before.
You will come to hospital to
- Give your first biopsies and blood samples
- Have your rigid sigmoidoscopy with biopsies after finishing the starch powder and give your second blood, urine and stool samples
So you will make 2 visits to hospital to take part in this study.
The team will give you your supply of starch powder at home. They will also pick up your first urine and stool sample at this time.
All operations and procedures carry a small risk.
There is a very small chance that colonoscopy or sigmoidoscopy could cause a hole in the bowel wall (a perforation). A perforation will almost always need surgery to fix it.
Bleeding from the bowel is a more common complication, but this is usually minor, and settles on its own.
The more biopsies you have, the higher the risk of bleeding or perforation.
Starch powder can sometimes cause
- Passing increased amounts of wind (flatulence)
- Mild tummy (abdominal) pain
- A swollen feeling in your tummy due to a build up of gas (bloating)
- Slight increase in bowel movements
These side effects will stop when you stop taking the powder. No one has ever reported serious side effects from starch powder.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor John Mathers
Biotechnology and Biological Sciences Research Council
National Institute for Health Research Cancer Research Network (NCRN)
Northumbria Healthcare NHS Foundation Trust
University of Newcastle