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临床试验/NCT01750138
NCT01750138Unknown不适用

Can Preoperative Oral Glutamine Facilitate Earlier Return of Gut Function in Patients Undergoing Colorectal Surgery. A Prospective Randomized Trial.

Scarborough General Hospital1 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2011年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
206
试验地点
1
主要终点
Gut function

研究概览

简要总结

The gastrointestinal tract has many functions; it provides nutrition, produces hormones, performs a barrier function, maintains a stable gastrointestinal micro flora and plays an important role in the inflammatory process as it is the largest producer of cytokines (proteins associated with inflammation). This gut function is impaired after colorectal (bowel) surgery. There is evidence to suggest that impaired gut function is associated with increased complications. Hence if gut function is preserved, it should equate with better outcomes. As a result, there has been increasing interest in treatments called Gut Specific Nutrients (GSN), which specifically target gut function. Most notable of them is Glutamine, a conditionally essential amino acid and preferred fuel source for intestinal cells. Research has shown that glutamine promotes cell growth, increases clearance of harmful organisms from the blood, and reduces the surgical stress response. In other words, glutamine has a favourable influence on gut function.

Recent studies from our unit using intravenous glutamine in critically ill patients have shown an early return of gut function, which in turn is associated with attenuation of the inflammatory response and improved outcomes. It is not known whether oral glutamine is associated with a similar outcome. A recent pilot study at our unit suggests an association between oral glutamine and early return of gut function. The aim of this research is to determine if giving oral glutamine results in an early return of gut function and whether this is associated with an attenuation of the systemic inflammatory response.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Participant, Investigator)

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All adult patients undergoing elective colorectal surgery (both open or keyhole) will be eligible for the study.

排除标准

  • Allergy to glutamine/placebo
  • Failure to obtain informed consent.
  • Patients with existing infections.
  • Pregnant women and children under the age of 18 years will be excluded from the study.
  • Patients on antibiotics in the previous 2 weeks.

研究组 & 干预措施

Glutamine

Experimental

Glutamine powder given preoperatively for five days

干预措施: Glutamine (Drug)

Placebo

Active Comparator

dextrose powder for 5 days pre-operatively

干预措施: Dextrose powder (Drug)

结局指标

主要结局

Gut function

时间窗: post op

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Syed Irfan Kabir

Research Fellow

Scarborough General Hospital

研究点 (1)

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