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临床试验/NCT01609660
NCT01609660已完成4 期

Impact of Probiotics on the Intestinal Microbiota and Its Association With Postoperative Outcome After Colorectal Surgery

Federal University of Minas Gerais0 个研究点目标入组 33 人开始时间: 2010年3月1日最近更新:
适应症

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

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

发起方
Federal University of Minas Gerais
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Isabel Toulson Davisson Correia

Professor of Surgery, responsible investigator

Federal University of Minas Gerais

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