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临床试验/NCT01758783
NCT01758783Unknown不适用

the Efficacy of Glutamine in the Therapy of Radiation Enteritis Among Patients Treated With Radiation of Abdomen and Pelvis.

Nanjing University School of Medicine1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012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
发起方
入组人数
30
试验地点
1
主要终点
inflammatory factor

研究概览

简要总结

Objective: To evaluate the effects of perioperative glutamine supplemented total parenteral nutrition support on nutritional status, immunologic function and intestinal permeability of patients with chronic radiation intestinal injury.

Methods: The 40 patients with CRII were randomized into two groups, the standard TPN group and glutamine-enriched TPN group. The patients were administered total parenteral nutrition for at least four weeks (two weeks pre-operation and two weeks post-operation). The nutritional status, immunologic function, plasma concentration of glutamine and intestinal permeability were measured at 1 day, 1 week and 2 weeks pre-operation, 3 day, 1 week and 2 weeks post-operation. Nutrition status was determined the plasma concentrations of hemoglobin, albumin, prealbumin, transferrin and triglyceride. Immunologic function were measured by the percentages of CD4+T cells and CD8+T cells, the ratio of CD4 +T cells to CD8+T cells ( CD4 +/CD8 +) was calculated, and serum IgA, IgM and IgG.The intestinal permeability was detected by the urinal ratio of lactulose and mannitol.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of chronic radiation enteritis
  • Need the operation
  • Malnutrition

排除标准

  • Hepatic failure
  • Kidney failure
  • Neoplasm recurrence
  • Serious cardiovascular/metabolic disease
  • Pregnancy and lactation

研究组 & 干预措施

placebo group

Placebo Comparator

干预措施: Glutamine (Drug)

Glutamine group

Experimental

干预措施: Glutamine (Drug)

结局指标

主要结局

inflammatory factor

时间窗: 2 weeks after the surgery

次要结局

未报告次要终点

研究者

发起方
Nanjing University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lei Zheng

Resident

Nanjing University School of Medicine

研究点 (1)

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