L Plantarum 299v to Patients Undergoing Colon Resection - a Randomized Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in intestinal bacterial microflora
研究概览
简要总结
Intestinal pathogenes are often involved in postoperative complications after colon surgery. Probiotic bacteria, i e live bacteria which have beneficial effects on the host when ingested, have been shown to reduce bacterial translocation in animal studies. However, in humans studies results have varied. The purpose with this study was to find whether high doses of Lactobacillus plantarum 299v affects the potentially pathogenic microflora of the gut, bacterial translocation and cell proliferation in patients undergoing planned colon surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •planned resection of colon for malignant or benign disease
排除标准
- •unable to understand instructions and perform preoperative intake of study preparation
- •rectal surgery
- •present or past history of endocarditis
- •congenital or acquired valvular heart disease
研究组 & 干预措施
1
Receives Lactobacillus plantarum 299v in an oatmeal drink, at a concentration of 10(9) colony-forming-units/ml, 100 ml per day, starting one week before surgery, finishing 5 days after surgery.
干预措施: Lactobacillus plantarum 299v in oatmeal drink (Dietary Supplement)
2
Receives oatmeal drink, 100 ml per day, starting one week before surgery, finishing 5 days after surgery.
干预措施: Oatmeal drink (Dietary Supplement)
结局指标
主要结局
Change in intestinal bacterial microflora
时间窗: Before inclusion, after treatment, during surgery, postoperative day 6, 6 weeks, 6 months
次要结局
- Bacterial translocation(During surgery)
- Inflammatory response (cytokines)(Preoperative, during operation, 3, 24 an 48 hours postoperastive)
- Cell proliferation(During surgery)
- Postoperative complications(One week after surgery)