Action of Synbiotics on Irradiated GI Mucosa in Rectal Cancer Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Rectal Cancer

Intervention / Treatment
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* Dietary Supplement: Oat bran
* Dietary Supplement: Oat bran and blueberry husks
* Dietary Supplement: No oral supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rectal cancer/Adenocarcinoma recti Informed Consent explained orally and written, understood, agreed and signed Exclusion Criteria: Diabetes Mellitus Inflammatory bowel disease Previous radiation to pelvis area Ongoing steroid or immunosuppressive therapy Ongoing antibiotics therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oat bran<br>45 g oat bran | Dietary Supplement: Oat bran<br>* 45 g oat bran.<br>|
| Experimental: Oat bran and blueberry husks<br>13 g freeze dried blueberry husks and 22 g oat bran + probiotic bacteria. | Dietary Supplement: Oat bran and blueberry husks<br>* 13 g freeze dried blueberry husks and 22 g oat bra + probiotic bacteria.<br>|
| Other: No oral supplementation<br>No oral supplementation. | Dietary Supplement: No oral supplementation<br>* No oral supplementation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Action of synbiotics on irradiated GI mucosa in rectal cancer treatment | 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. | 2 weeks | 
| Action of synbiotics on irradiated GI mucosa in rectal cancer treatment | 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. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiotherapy, probiotics