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临床试验/NCT00695461
NCT00695461已完成不适用

L Plantarum 299v to Patients Undergoing Colon Resection - a Randomized Placebo-Controlled Study

Skane University Hospital2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2001年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
2
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

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

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)

研究者

申办方类型
Other

研究点 (2)

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Lactobacillus Plantarum 299v in Colon Surgery | 临床试验