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Blueberry

13 g freeze dried blueberry husks and 22 g oat bran + probiotic bacteria.

Oat bran

13 g freeze dried blueberry husks and 22 g oat bra + probiotic bacteria.

Oat bran and blueberry husks

No oral supplementation

Bengt Jeppsson, Prof

The aim of this study is to investigate how bacteria and fibre interact with the epithelial cells of the gastrointestinal mucosa to reduce inflammation and to diminish tissue damage caused by radiation therapy to patients diagnosed with rectal cancer.

Thirty patients diagnosed with rectal cancer receiving short term radiation therapy 25 Gray (Gy) during one week preoperatively will be examined. The patients will be divided into three groups with ten patients in each group. One control group without no treatment/study product, one group receiving a test product of 45 g of oat bran and freezing medium only, and one group having a probiotic bacteria, Lactobacillus plantarum HEAL 19 (1010 CFU/g), freezed dried blueberry husks (13 g) and oat bran (22 g), corresponding to 8 g fibre per day in each of the two treated groups. The patients will consume the test product once a day 1 week before and during radiotherapy (2 weeks in total). Mucosal biopsies for microflora analysis and blood samples for analysis of SCFAs and cytokines will be collected at inclusion as well as faecal samples. After radiation therapy, at surgery, blood samples, faecal samples and mucosal biopsies are collected. Fresh faecal samples, blood samples and mucosal biopsies are stored at -80°C until analysis.

Action of Synbiotics on Irradiated GI Mucosa in Rectal Cancer Treatment

Randomized Clinical Trial of Effects of Synbiotics on Intestinal Microbiota in Patients Undergoing Short-course Preoperative Radiotherapy During Treatment of Rectal Cancer

Reaction of gastrointestinal mucosa in a clinical setting in patients with preoperative radiotherapy treatment of rectal cancer pre-treated with either a probiotic bacteria, blueberry husks and oat bran, oat bran only or no pre-treatment at all, measured by analysis of bacterial diversity.

Reaction of gastrointestinal mucosa in a clinical setting in patients with preoperative radiotherapy treatment of rectal cancer pre-treated with either a probiotic bacteria, blueberry husks and oat bran, oat bran only or no pre-treatment at all, measured by analysis of inflammation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Action of Synbiotics on Irradiated GI Mucosa in Rectal Cancer Treatment	NCT03420443	Rectal Cancer	Oat bran Oat bran and bl... No oral supplem...	18 Years - 80 Years	Region Skane
Action of Synbiotics on Irradiated GI Mucosa in Rectal Cancer Treatment	NCT03420443	Rectal Cancer	Oat bran Oat bran and bl... No oral supplem...	18 Years - 80 Years	Region Skane

Spots Global Cancer Trial Database for no oral supplementation