Extract

Background and study aims Oily fish such as mackerel and sardines contain natural omega-3 fatty acids (O3FAs). They are commonly used as nutritional supplements in capsule form, with evidence suggesting numerous health benefits including improved cognitive performance, maintenance of a healthy heart and even possible anti-cancer effects. There is however little known about the amount of O3FA that enter an individual’s large bowel after taking O3FA capsules. This is of particular interest as O3FAs may have numerous effects on the environment within the bowel, including anti-bowel cancer effects and possible changes in the type and balance of bacteria. The aim of our study is to measure the amount of O3FAs present in the stoma fluid after taking daily O3FA capsules for 4 weeks. We will also examine how O3FAs alter the balance of bacteria within the gut. Who can participate? Patients aged 50 or over with a temporary ileostomy (An ileostomy is where the bowel is diverted through an opening in the tummy [stoma] to collect waste products in a bag. They are performed to allow the bowel to heal after surgery to treat bowel cancer). What does the study involve? Participants are required to take two O3FA gelatin capsules twice a day with meals for 4 weeks. The O3FA capsules contain naturally occurring fatty acids found in oily fish such as mackerel and sardines. They are widely available for people to buy over the counter from pharmacies and supermarkets. The amount of O3FA within the stoma fluid is measured after taking the O3FA capsules for 4 weeks. Participants provide a stoma fluid sample at three separate visits over the 4 week period. At the start and end of the study participants also provide blood samples to measure the levels of O3FAs in the blood. What are the possible benefits and risks of participating? Although O3FA supplementation is associated with many health benefits, taking part in this study is unlikely to directly help participants. However, the results of the study may help plan future research exploring the beneficial effects of O3FAs against bowel cancer. Participants may get some mild side-effects such as indigestion-type symptoms (including belching or change in stoma volume), at which stage they can decide whether to reduce or stop supplementation temporarily or permanently. Sometimes symptoms disappear if the daily dose is reduced. If participants stop taking the capsules during the 4 weeks, a stoma fluid sample and blood test is still required at the end of the study. Where is the study run from? St James University Hospital Leeds (UK) When is the study starting and how long is it expected to run for? October 2015 to October 2016 Who is funding the study? Leeds Teaching Hospital Charitable Trust (UK) Who is the main contact? Dr Henry Watson [email protected]

Inclusion criteria

• Participants with a loop ileostomy following anterior resection for colorectal cancer

Links

• ictrp
• isrctn