Impact of Probiotics on the Intestinal Microbiota and Its Association With Postoperative Outcome After Colorectal Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 主要终点
- Mucosal cytokine
研究概览
简要总结
The purpose of this study is to assess the impact of probiotic administration (Saccharomyces boulardii) on patients undergoing colorectal resections comparing to the routine protocol by assessing: (1)intestinal microbiota modulation using RT-PCR to measure cytokine in the mucosa; (2) assess postoperative complications, mainly infectious and mortality, as well as length of hospital stay
详细描述
The intestinal microbiota, a complex and dynamic population of different bacterial species, under normal circumstances, represents an important contribution to the health of the host. This plays a key role by maintaining the integrity of the epithelial barrier and helping the development of mucosal immunity. However, under some stressful situations, such as after gastrointestinal surgery, infectious complications may be originated from the patient's own intestinal microbiota. This leads to the so called "gut origin of sepsis" hypothesis. On the other hand, under similar conditions, the supply of probiotics, the good bacteria, has been shown to be beneficial, despite few controversial results. Therefore, it is important to carefully assess the efficacy of probiotics in the prevention and treatment of complications in surgical patients, as well as to evaluate the safety of its use.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •older than 18 years old
- •intend to undergo elective colon resection at the UFMG Hospital
排除标准
- •Patients in use of steroids
- •Patients unable to receive the probiotics for, at least, 7 days before the operation
- •Changes to the operation strategy
- •Patients that discontinued probiotic use
- •Patients who had previously taken any probiotic or prebiotic
结局指标
主要结局
Mucosal cytokine
时间窗: April 2013
To assess mucosal cytokine levels
次要结局
- Short chain fatty acids(April 2013)
研究者
Maria Isabel Toulson Davisson Correia
Professor of Surgery, responsible investigator
Federal University of Minas Gerais
