Randomized Clinical Trial of Effects of Synbiotics on Intestinal Microbiota in Patients Undergoing Short-course Preoperative Radiotherapy During Treatment of Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 30
- 主要终点
- Action of synbiotics on irradiated GI mucosa in rectal cancer treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rectal cancer/Adenocarcinoma recti
- •Informed Consent explained orally and written, understood, agreed and signed
排除标准
- •Diabetes Mellitus
- •Inflammatory bowel disease
- •Previous radiation to pelvis area
- •Ongoing steroid or immunosuppressive therapy
- •Ongoing antibiotics therapy
研究组 & 干预措施
Oat bran
45 g oat bran
干预措施: Oat bran (Dietary Supplement)
Oat bran and blueberry husks
13 g freeze dried blueberry husks and 22 g oat bran + probiotic bacteria.
干预措施: Oat bran and blueberry husks (Dietary Supplement)
No oral supplementation
No oral supplementation.
干预措施: No oral supplementation (Dietary Supplement)
结局指标
主要结局
Action of synbiotics on irradiated GI mucosa in rectal cancer treatment
时间窗: 2 weeks
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.
次要结局
未报告次要终点