The Impact of Lactobacillus Plantarum 299v in Combination With Inulin on Gut Microbiome, Chemotherapy and Radiotherapy-induced Diarrhoea, and Clostridioides Difficile Infection in Colorectal Cancer Patients in Periooperative Period
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- gut microbiota composition
研究概览
简要总结
Colorectal cancer in periooperative period patients (n=60) will be enrolled to this study. Participants will be divided into 4 groups as follows:
- group 1 (n=15) will receive 2 capsules (per day) of L. plantarum 299v L. plantarum 299v (Sanprobi IBS®) for 4 weeks
- group 2 (n=15) will receive L. plantarum 299v (2 capsules per day) and inulin (4 g) for 4 weeks
- group 3 (n=15) will receive placebo (2 capsules per day) and inulin (4 g) for 4 weeks
- group 4 (n=15) will receive placebo (2 capsules per day) for 4 weeks
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 oraz ≤65
- •patients with colorectal cancer prior to surgical treatment
- •qualification to surgery
- •the treatment with chemotherapy and radiotherapy in preoperative period
- •an appropriate swallowing
- •patients agreement to take part in this study
排除标准
- •the presence of other cancers than colorectal cancer
- •inflammatory bowel diseases
- •dysphagia
- •intake of antibiotics, proton pump inhibitors, probiotics, and synbiotics 3 months befor taking part in this study
研究组 & 干预措施
Lactobacillus plantarum 299v
15 patients will receive 2 capsules (per day - 1 capsule contains 10x10 CFU) of L. plantarum 299v for 4 weeks
干预措施: Sanprobi IBS® (Dietary Supplement)
Lactobacillus plantarum 299v in combination with inulin
15 patients will receive 2 capsules (per day - 1 capsule contains 10x10 CFU) of L. plantarum 299v and inulin (4 g) for 4 weeks
干预措施: Sanprobi IBS® (Dietary Supplement)
Placebo in combination with inulin
15 patients will receive 2 capsules (per day) of placebo and inulin (4 g) for 4 weeks
Placebo
15 patients will receive 2 capsules (per day) of placebo for 4 weeks
结局指标
主要结局
gut microbiota composition
时间窗: 4 weeks
It will be measured by presenting alpha diversity and beta-diversity of microbial community and after that it will be presented using bioinformatic analysis.
次要结局
- chemotherapy and radiotherapy-induced diarrhoea(4 weeks)
- Clostridioides difficile infection(6 months)